Homology Medicines Announces Presentation of Positive Data from the Dose-Escalation Phase of the pheNIX Gene Therapy Trial for Adults with PKU | DNA…

Details Category: DNA RNA and Cells Published on Friday, 06 November 2020 17:53 Hits: 882

- Marked Reductions in Phe Observed at Two Doses -

- Achieved Goal with Plans to Advance to Randomized, Concurrently Controlled Expansion Phase of Trial -

BEDFORD, MA, USA I November 06, 2020 I Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today the presentation of positive data from the dose-escalation portion of the Phase 1/2 gene therapy pheNIX clinical trial for adults with phenylketonuria (PKU). The results showed that product candidate HMI-102 was generally well-tolerated, and resulted in marked reductions in phenylalanine (Phe) and the Phe-to-tyrosine (Tyr) ratio (Phe/Tyr ratio) at two doses. Phe is a registrable endpoint in PKU, and the Phe/Tyr ratio is a clinically relevant diagnostic measurement for PKU. With these positive results, Homology is progressing to the randomized, concurrently controlled expansion phase of the trial, which has the potential to be converted to a registrational trial.

The data were presented today in an oral presentation by Olaf Bodamer, M.D., Ph.D., FACMG, FAAP, Park Gerald Chair in Genetics & Genomics and Associate Chief of Genetics & Genomics at Boston Childrens Hospital, and principal investigator of the pheNIX trial, during the New England Consortium of Metabolic Programs (NECMP) annual meeting, which is focused on new research in metabolic disorders. NECMP includes metabolic clinics, healthcare providers, patient organizations and others dedicated to increasing knowledge of metabolic disorders and improving delivery of healthcare to patients.

This is the first-ever PKU gene therapy clinical trial, and I am excited to share these data with the PKU community as I believe they demonstrate the potential of HMI-102 to treat the underlying genetic cause and reduce the therapeutic burden for patients and their families, stated Dr. Bodamer. PKU is a challenging condition, and a treatment that establishes normal metabolism could change the prognosis for patients with this rare genetic disorder. We look forward to participating in the next phase of the study.

We are pleased to have met the goals of the dose-escalation portion of the trial, which were evaluation of safety and efficacy of a single I.V. administration of HMI-102 and dose determination for the expansion phase of the trial, stated Gabe Cohn, M.D., Chief Medical Officer of Homology Medicines. Even as many patients self-liberalized their diets, there were patients at the mid- and high-doses with plasma Phe values below 360 mol/L and/or 600 mol/L, and one of these patients achieved a Phe level within the normal range. This is the first time a genetic medicines approach has achieved these results in patients with PKU. We have learned a tremendous amount in the dose-escalation phase and are applying these learnings to the expansion phase of the trial, which we anticipate initiating in early 2021.

Dr. Cohn continued, We greatly appreciate the PKU community of patients, clinicians and caregivers who have participated in this first phase of the pheNIX trial, and we look forward to working together during the next phase.

As of the data cutoff date of October 19, 2020, six patients in the dose-escalation phase of the pheNIX trial had received gene therapy product candidate HMI-102 across three dose cohorts (low-dose Cohort 1, n=2; mid-dose Cohort 2, n=2; high-dose Cohort 3, n=2). Cohorts included males and females, with an age range of 21-49 and time in study ranging from 13 weeks to 52 weeks (end of study).

Safety Observations HMI-102 was generally well-tolerated, and there were no treatment-related serious adverse events (SAEs). There were no clinically significant changes in ECG or vital signs and no clinical signs of complement activation. The Grade 1 and 3* alanine aminotransferases (ALTs) observed in Cohorts 2 and 3, which is common in AAV-based gene therapy, were managed with increased steroids when necessary. The patients who experienced Grade 3 ALTs had pre-existing underlying immune conditions. An independent data monitoring committee, which provided guidance throughout the pheNIX trial, concluded that there were no safety concerns related to bilirubin, and that ALT elevations may be associated with reduced efficacy.

Updates to the expansion phase of the pheNIX trial, including key learnings related to patient selection, monitoring and steroid regimen, are being incorporated.

Efficacy Observations

Cohort 1 (Low-Dose) Through 52 weeks, patients in Cohort 1 continued to show no meaningful reductions in Phe.

Cohorts 2 and 3 (Mid- and High-Dose) The mean percent change from baseline in Phe observed in patients in Cohorts 2 and 3 were significant, compared to Cohort 1**. These Phe reductions occurred while patients self-liberalized their diets.

Through 48 weeks, one patient in Cohort 2 had Phe levels of <360 mol/L and/or <600 mol/L*** at multiple timepoints and had reached a minimum Phe level of 42 mol/L, compared with a baseline level of 1,010 mol/L. Through 13 weeks, one patient in Cohort 3 had a Phe level <360 mol/L and several Phe levels <600 mol/L at multiple timepoints and had reached a minimum Phe level of 303 mol/L, compared with a baseline level of 1,060 mol/L.

In Cohorts 2 and 3, Phe reductions were greater among patients with Grade 1 ALTs compared to patients with Grade 3 ALTs****; ALT elevations were managed with increased steroids when necessary. It appears higher ALT elevations may limit therapeutic activity, but can be managed with a modified steroid regimen, which is being incorporated into the expansion phase.

Expansion Phase Based on the safety and efficacy results observed in the dose-escalation phase, Homology is advancing to the randomized, concurrently controlled, dose expansion phase of the pheNIX trial, which has the potential to be converted to a registrational trial.

All cohorts in the dose-escalation phase showed an acceptable safety profile and certain patients in Cohorts 2 and 3 showed marked Phe reductions. Based on these collective data, Homology has selected two doses for the expansion phase: the mid-dose from Cohort 2 and a dose between the doses in Cohorts 2 and 3. The Company believes the latter dose has the potential to improve Phe reductions while reducing steroid exposure that was required at the high-dose. The Company believes that advancing two doses in parallel provides the potential to convert to a registrational trial quickly with the optimal dose as the expansion phase does not include staggered dosing between patients.

Webcast/Conference Call Homology management and Dr. Bodamer will host a conference call and webcast today, Friday, November 6 at 4:30 p.m. ET. The webcast will be accessible on Homologys website in the Investors section, and the webcast replay will be available on the website for 90 days following the presentation. To access using the conference call line, dial (866) 244-8091 (U.S./Canada toll-free) or (602) 563-8623, with Conference ID 7394503.

About HMI-102 HMI-102 is an investigational gene therapy in clinical development for the treatment of phenylketonuria (PKU) in adults. HMI-102 is designed to encode the PAH gene, which is mutated in people with PKU, delivered via the liver-tropic AAVHSC15 vector. Homology has received Fast Track Designation and orphan drug designation for HMI-102 from the U.S. Food and Drug Administration (FDA), and orphan drug designation from the European Medicines Agency (EMA).

About Phenylketonuria (PKU) PKU is a rare inborn error of metabolism caused by a mutation in thePAHgene. PKU results in a loss of function of the enzyme phenylalanine hydroxylase, which is responsible for the metabolism of phenylalanine (Phe), an amino acid obtained exclusively from the diet. If left untreated, toxic levels of Phe can accumulate in the blood and result in progressive and severe neurological impairment. Currently, there are no treatment options for PKU that target the underlying genetic cause of the disease. According to the National PKU Alliance, PKU affects nearly 16,500 people in the U.S. with approximately 350 newborns diagnosed each year. The worldwide prevalence of PKU is estimated to be 50,000 people.

About Homology Medicines, Inc. Homology Medicines, Inc. is a genetic medicines company dedicated to transforming the lives of patients suffering from rare genetic diseases with significant unmet medical needs by curing the underlying cause of the disease. Homologys proprietary platform is designed to utilize its human hematopoietic stem cell-derived adeno-associated virus vectors (AAVHSCs) to precisely and efficiently deliver genetic medicinesin vivoeither through a gene therapy or nuclease-free gene editing modality across a broad range of genetic disorders. Homology has a management team with a successful track record of discovering, developing and commercializing therapeutics with a particular focus on rare diseases, and intellectual property covering its suite of 15 AAVHSCs. Homology believes that its compelling preclinical data, scientific expertise, product development strategy, manufacturing capabilities and intellectual property position it as a leader in the development of genetic medicines. For more information, please visitwww.homologymedicines.com.

*ALT Grades based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5 **P<0.004; Post-hoc comparison of Cohort 1 vs Cohorts 2&3 using repeated measures MANOVA/regression analysis ***U.S. and EU PKU treatment guidelines described in: Vockley J et al. Phenylalanine hydroxylase deficiency: diagnosis and management guideline. Genetics in Medicine 2014;16: 188-200. van Spronsen FJ et al. Key European guidelines for the diagnosis and management of patients with phenylketonuria. Lancet Diabetes Endocrinol 2017; 5: 74356. ****P<0.05; Post-hoc comparison of Patients 3&6 vs Patients 4&5 using repeated measures MANOVA/regression analysis

SOURCE: Homology Medicines

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Homology Medicines Announces Presentation of Positive Data from the Dose-Escalation Phase of the pheNIX Gene Therapy Trial for Adults with PKU | DNA...

COVID vaccine to be rolled out within months: Hunt – Daily Mercury

Health Minister Greg Hunt has announced Pfizer's groundbreaking COVID vaccine will be rolled out in Australia from March.

"I'm delighted to announce that the government has secured as part of its agreement with Pfizer, full cold chain logistics, distribution for the Pfizer vaccine.

It's what you call an mRNA vaccine, we have 10m units of that, part of a 134.8m unit, four-vaccine strategy We have secured that for Australia, well ahead of expectations and on schedule, to deliver vaccines to Australians, commencing in March 2021," he said.

"That is I think extremely important news. While, again, the advice is today that we may well have another zero community transmission case day for Australia, they are still waiting on two jurisdictions, we nevertheless have to be aware that we will not be out of this until we have a nation which has had a full vaccination program."

The Therapeutic Goods Administration has given the AstraZeneca and Pfizer vaccines the green light after "very promising" data from early clinical trial phases.

This puts both developers on track for approval in January and for Australians to be vaccinated against COVID-19 from March 2021.

"It essentially expedites the process and brings critical medicines, or vaccines, at a faster rate then would otherwise be the case but with an absolute premium on safety," Mr Hunt said.

The Therapeutic Goods Administration is expected to receive more clinical information needed to approve the vaccines around December.

The news comes as the Morrison government confirmed it would be able to distribute Pfizer's world-first messenger ribonucleic acid (mRNA) type vaccine, which needs to be kept at minus 70C.

Very "sophisticated eskies", which require dry ice that lasts for 14 days, would be used to hold and transport the vaccines, Therapeutic Goods Administration deputy secretary John Skerritt said.

"(The eskies) can be refilled twice without the need to connect to electricity," Professor Skerritt said.

"These eskies with the two refills gives you a month-and-a-half of cold chain protection."

The distribution process that goes to the National Cabinet on Friday includes giving vaccines to hospitals, respiratory clinics and general practices.

Professor Skerritt said the eskies would speed up the rollout of the vaccines because they allowed for multiple distribution points.

However, he said the jabs would not be approved until experts were confident they met the requirements of efficacy and safety.

WHO WILL GET THE COVID VACCINE:

The first batch of Pfizer's successful COVID-19 vaccine will reach just a fifth of the Australian population, starting with frontline health workers and the elderly.

These five million Australians will receive two doses of the drug - using all ten million rations the government has secured - and we can't manufacture more doses here.

The roll out of the vaccine, in the first three to six months of 2021, will also be difficult because it has to be kept at an extremely low temperature - minus 70 degrees - to remain stable.

There should be just enough doses for the 609,000 practising frontline health workers including doctors, nurses, dentists, pharmacists, 3.8 million people aged over 65 and 250,000 aged care workers.

Prime Minister Scott Morrison said the Pfizer trial results were "very promising and I'm optimistic and hopeful next year about the rollout of those vaccine programs".

Like much of the world, Australia's sharemarket responded positively to the vaccine news.

The key S&P/ASX 200 index closed 42 points higher at 6341, a 0.7 per cent rise for the day, after surging 2.2 per cent in morning trade.

Health Minister Greg Hunt told News Corp Pfizer had committed to providing the cold chain delivery equipment to distribute the vaccine in Australia.

Experts warn the vaccine won't mean the end of social distancing, handwashing and mask wearing until almost every Australian has received it.

CSIRO's Director of biosecurity Dr Rob Grenfell said while the vaccine would prevent people getting sick but it would not "prevent you getting colonised by the virus".

To eliminate the virus entirely, vaccines would have to be developed to stop the virus in the nasal cavity. The Pfizer vaccine does not do this.

Successful trials by Australia's Doherty Institute of delivering the Oxford AstraZeneca vaccine into the noses of ferrets have led to a human trial of this method in the UK.

"If that develops an immunity at the surface of the nasal cells and it's demonstrated to have nasal sterility, which is really the endpoint you're looking for, that would then go a long way towards decreasing the spread of the virus," Dr Grenfell said.

Conventional vaccines use a weakened form of the virus to prompt an immune response but mRNA vaccines like the one made by Pfizer use the virus's genetic code to make a person's own cells produce vaccine antigens and generate immunity.

This new age vaccine technology has never been used in humans before.

Nucleus Network's Paul Griffin has trialled a number of mRNA flu vaccines in humans with no serious side effects.

"It's not gene therapy, it is not able to be incorporated into the host genome so there's absolutely no prospect of altering human DNA using the vaccine," he said.

While Australia's vaccine manufacturer CSL is producing two other COVID-19 vaccine candidates it does not have the equipment needed to make Pfizer's mRNA vaccine and we will be dependent on receiving our supply of the vaccine from overseas manufacturers.

Mr Hunt told News Corp the government was considering over the longer term setting up an advanced pharmaceutical manufacturing plant in Australia that could produce this new type of vaccine.

While pharmaceutical giant Pfizer and BioNTech announced clinical trials of their COVID-19 vaccine were 90 per cent effective, the study was yet to be published or peer reviewed.

Pfizer said it would produce 50 million doses of its vaccine by the end of the year and 1.3 billion doses in 2021 but this would be enough to vaccinate less than one per cent of the world's population.

There are over 200 vaccines in development and more than 40 are in clinical trials with several key trials due to report this month.

The Australian Government has deals to buy a total of 134 million vaccine doses made by Oxford AstraZeneca, University of Queensland, Novavax and Pfizer.

The Australian sharemarket rise was more subdued than offshore markets where key share indices in the US, Britain and Europe soared between 3 and 7 per cent.

Among local stocks were some big movers, with Corporate Travel Management climbing 16 per cent and Flight Centre adding more than 8 per cent.

Investment platform eToro's market analyst, Adam Vettese, said the vaccine news had "injected optimism into travel stocks in particular".

"However, while this is obviously a positive step forward there is still a way to go," he said.

JBS Financial Strategists CEO Jenny Brown said markets were forward-looking and buyers were betting on a return to international travel.

"There's a lot of positivity but it has pulled back a bit," she said.

MORE NEWS

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Aussie gangsters to be extradited on drug charges

Originally published as The Aussies who will get Pfizer's COVID-19 vaccine

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COVID vaccine to be rolled out within months: Hunt - Daily Mercury

Blockchain offers advanced therapy tracking – Bioprocess InsiderBioProcess – BioProcess Insider

Hataali blockchain technology used to secure supply chain in the UK could lead to a standardized infrastructure for cell and gene therapy tracking, says ATMPS.

ATMPS, a spin out from Farmatrust and the creator of the Hataali platform, tested the blockchain solution alongside the UKs University Hospitals Birmingham NHS Foundation Trust (UHB).

UHB is home to the Midlands and Wales Advanced Therapy Treatment Centre, which is comprised of partners from the NHS, academia and industry. The center, one of three across the UK, delivers advanced therapies to UK patients.

Image: iStock/ipopba

Hataali was tested alongside the UHBs system, where it was found that the blockchain platform was interoperable, with ATMPS suggesting that its platform had become the first functional blockchain solution for advanced therapeutic products.

The platform is utilized to record scheduling and ordering data for advanced therapy medicinal product (ATMP) treatments within a blockchain system that enables secure and confidential sharing of data between partners.

The solution allows for the activities of manufacturers, clinics, hospitals, and specialist couriers to be shared digitally, as well as being able to provide a regulatory audit trail. Essentially, a digital chain of records is created that allows for communication along each step of the supply chain.

In terms of what benefits this provides over existing platforms and the level of information available to stakeholders, a spokesperson for ATMPS outlined: Its not just an improvement on, say, serialization, as it gives on open access window to access user appropriate data e.g. doctors can better plan appointments, regulators can be secure in the supply chain conditions, and patients and innovators can know exactly where the treatment is, and crucially be alerted if there is a problem.

Now that the trial is complete, ATMPS plans to use this initial rollout as an example to widen the use of the platform. The spokesperson described the partnership with UHB as just the start of the process, with the platform designed to be multi-treatment, multi-site and multi-stakeholder.

This sees ATMPS considering the next stage for the platform being UK-wide utilization. Eventually, however, the company foresees a global structure whereby each new advanced therapy that gets approved in various markets enters a standardized infrastructure.

For Hataali itself, this means that the developers have already created the platform to function across time zones and to include multiple languages.

The patent for the platform is currently still pending, which means that rivals could potentially create an alternative platform based on the same premise.

There are already existing tracking platforms available on the market, though their scope through the supply chain is more limited, such as TrakCels supply chain monitoring technology that is able to track manufacturing processes in real-time for cell and gene therapies.

However, the spokesperson for ATMPS was unconcerned about potential rivals, Our solution is unique in that it is the only vein-to-vein solution out there that uses a blockchain foundation. So, even while its patent pending, I dont think we will see many investors trying to bring forward a competitive solution, they explained.

Furthermore, blockchain is complicated technically and any platform developed with this market in mind is required to be compliant with HIPAA and GDPR regulations, they added.

ATMPS spokesperson observed that those working in blockchain hold the ethos and mindset that collaborating and competing is the best way to push forward their own company, and healthcare more broadly.

They concluded, We are always keen to explore joint opportunities and to work with other solution providers that are operating in this novel specialist area, and we have no problem with anyone working or integrating with us, competitors or not.

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Blockchain offers advanced therapy tracking - Bioprocess InsiderBioProcess - BioProcess Insider

Flexion Therapeutics Reports Third-Quarter 2020 Financial Results and Recent Business Highlights – GlobeNewswire

November 04, 2020 16:01 ET | Source: Flexion Therapeutics, Inc.

BURLINGTON, Mass., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported financial results and recent business highlights for the quarter ended September30, 2020.

Throughout the third quarter, we saw strong execution across all areas of our business, and we were particularly pleased to achieve $23.7million in ZILRETTA net sales, said Michael Clayman, M.D., President and Chief Executive Officer of Flexion Therapeutics. We firmly believe that ZILRETTA can play an increasingly prominent role in helping the millions of patients who confront osteoarthritis knee pain, and our confidence in its long-term potential has only grown. Furthermore, during the quarter we made outstanding progress with our pipeline of innovative product candidates. We advanced FX201, our investigational intra-articular gene therapy product candidate for osteoarthritis, into the second cohort of the Phase 1 safety and tolerability study, and we remain on track to file an IND and potentially initiate clinical trials for FX301, our locally administered peripheral nerve block candidate for control of postoperative pain in 2021.

Third-Quarter Results & Financial Highlights

The Company reported a net loss of $24.6million for the third quarter of 2020, compared to a net loss of $38.2million for the same period of 2019. Net sales of ZILRETTA were $23.7million and $21.8million for the three months ended September 30, 2020 and 2019, respectively.

Cost of sales was $5.1million and $2.9million for the three months ended September 30, 2020 and 2019, respectively. For the three months ended September 30, 2020, cost of sales included $2.0million for the actual cost of units sold and $3.1million of unabsorbed overhead associated with the voluntary, temporary suspension of manufacturing activities at Patheon due to COVID19 impacts on sales of ZILRETTA. For the three months ended September30, 2019, cost of sales was comprised of $1.8million related to the actual cost of units sold, $0.9million related to unabsorbed manufacturing costs and $0.2million of period costs and other adjustments.

Research and development expenses were $10.1million and $20.9million for the three months ended September30, 2020 and 2019, respectively. The decrease in research and development expenses of $10.8million was primarily due to a decrease of $5.9million in development expenses for ZILRETTA due to a reduction in ZILRETTA life cycle management activities, a decrease in $2.9million in portfolio expansion-related expenses as the upfront payment for the purchase of XEN402 from Xenon Pharmaceuticals occurred in the third quarter of 2019, as well as a decrease of $1.4million in salary and other employee-related costs and stock-based compensation expense related to lower headcount.

Selling, general and administrative expenses were $27.3million and $32.1million for the three months ended September30, 2020 and 2019, respectively. Selling expenses were $19.3million and $23.9million for the three months ended September30, 2020 and 2019, respectively. The year-over-year decrease of $4.6million was primarily due to the expense reduction measures taken in response to COVID19; in particular, the elimination of live presence at industry conferences, reductions in in-person physician speaker programs and reductions in select marketing programs and materials, as well as a reduction in travel expenses due to physician office limitations and travel guidelines and restrictions at the state and local level. General and administrative expenses were $8.0million and $8.2million for the three months ended September30, 2020 and 2019, respectively, which represents a decrease of $0.2million.

Flexion expects full-year 2020 total operating expenses (including cost of sales, research and development, and selling, general and administrative) will be in the range of $172million to $182million.

Interest income was $0.1million and $0.7million for the three months ended September30, 2020 and 2019, respectively. Interest expense was $5.1million and $4.7million for the three months ended September30, 2020 and 2019, respectively.

As of September30, 2020, the Company had approximately $185.3million in cash, cash equivalents and marketable securities compared with $136.7million as of December31, 2019. Based on the Companys current operating plan and assuming purchasing activity at physician practices, clinics and certain medical centers or hospitals that administer ZILRETTA continue to return to pre-COVID19 levels, Flexion believes that its current cash, cash equivalents and marketable securities will be sufficient to fund operations into 2022.

Recent News & Business Updates

Indication and Select Important Safety Information for ZILRETTA

Indication:ZILRETTA is indicated as an intra-articular injection for the management of OA pain of the knee.

Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.

Contraindication:ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.

Warnings and Precautions:

Adverse Reactions:The most commonly reported adverse reactions (incidence 1%) in clinical studies included sinusitis, cough, and contusions.

Please seeZilrettaLabel.comfor full Prescribing Information.

About ZILRETTA (triamcinolone acetonide extended-release injectable suspension) On October6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting OA-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonidea commonly administered, short-acting corticosteroidwith a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at http://www.zilretta.com.

About FX201 (humantakinogene hadenovec) FX201 is a novel, intra-articular gene therapy product candidate that utilizes a helper-dependent adenovirus [HDAd] vector based on human serotype 5 (Ad5) that is designed to transfer a gene to cells in the joint to produce an anti-inflammatory protein, interleukin-1 receptor antagonist (IL-1Ra), under the control of an inflammation-sensitive promoter. Inflammation is a known cause of pain, and chronic inflammation is thought to play a major role in the progression of OA. By persistently suppressing inflammation, Flexion believes FX201 holds the potential to provide long-term pain relief and functional improvement, and to modify the disease.

About FX301 (funapide formulated in a proprietary thermosensitive hydrogel) FX301 is a locally administered NaV1.7 inhibitor product candidate, known as funapide, formulated for extended release in a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion believes FX301 has the potential to provide effective and durable pain relief while preserving motor function and anticipates initiating clinical trials in 2021.

About Osteoarthritis (OA) of the Knee OA, also known as degenerative joint disease, affects more than 30million Americans and accounts for more than $185billion in annual expenditures. In 2017, approximately 15million Americans were diagnosed with OA of the knee and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity and sports injuries. Each year, approximately five million OA patients receive either a corticosteroid (immediate-release or extended-release) or hyaluronic acid intra-articular injection to manage their knee pain.

About Flexion Therapeutics Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, the most common form of arthritis. The Company's core values are focus, ingenuity, tenacity, transparency and fun. Please visitflexiontherapeutics.com.

Forward-Looking StatementsThis release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts are forward looking statements, including, but not limited to, statements relating to the future of Flexion; expectations related to Flexions expenses for the year ended December31, 2020, and cash runway; timing and plans with respect to clinical trials; expected impacts from COVID-19 and the timing and duration of such impacts; the long-term potential of ZILRETTA; expected increases in the rate of individuals with OA of the knee; and the potential therapeutic and other benefits of ZILRETTA and our product candidates. These forward-looking statements are based on managements expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the fact that the impacts and expected duration of the COVID19 pandemic are uncertain and rapidly changing; risk that we may not achieve expense expectations for 2020; the potential for unexpected expenditures or cash requirements; the risk that we may not be able to successfully maintain an effective sales force to commercialize ZILRETTA; competition from alternative therapies; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to ZILRETTA; the risk that ZILRETTA may not be successfully commercialized or adopted; risks regarding our ability to obtain adequate reimbursement from payers for ZILRETTA; risks related to the manufacture and distribution of ZILRETTA, including our reliance on sole sources of supply and distribution; risks related to clinical trials, including potential delays, safety issues, or negative results; risks related to key employees, markets, economic conditions, health care reform, prices, and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading Risk Factors in our Quarterly Report on Form10-Q for the quarter ended June30, 2020, filed with the SEC on August5, 2020, and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Contact:

Scott Young Vice President, Corporate Communications & Investor Relations T: 781-305-7194 syoung@flexiontherapeutics.com

Julie Downs Associate Director, Corporate Communications & Investor Relations T: 781-305-7137 jdowns@flexiontherapeutics.com

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Lynparza approved in the EU as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer | Small Molecules | News…

Details Category: Small Molecules Published on Thursday, 05 November 2020 11:36 Hits: 85

Patients treated with Lynparza and bevacizumab lived without disease progression for a median of 37.2 months vs. 17.7 months with bevacizumab alone

One in two women with advanced ovarian cancer has an HRD-positive tumour

LONDON, UK I November 5, 2020 I AstraZeneca and MSDs Lynparza (olaparib) has been approved in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer.

Ovarian cancer is the fifth most common cause of cancer death in the EU and the five-year survival rate is approximately 45%, due partly because women are often diagnosed with advanced disease (Stage III or IV).1-3

The approval by the European Commission was based on a biomarker subgroup analysis of the PAOLA-1 Phase III trial which showed Lynparza, in combination with bevacizumab maintenance treatment, demonstrated a substantial progression-free survival (PFS) improvement versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2020.

Isabelle Ray-Coquard, principal investigator of the PAOLA-1 Phase III trial and medical oncologist, Centre Lon Brard and President of the GINECO group, Paris, France, said: For women with advanced ovarian cancer, the goal of 1st-line treatment is to delay disease progression for as long as possible with the intent of achieving long-term remission. Unfortunately, once a patients cancer recurs, it historically has been incurable. Lynparza together with bevacizumab has demonstrated an impressive median progression-free survival benefit of more than three years and is poised to become the standard of care for eligible patients with HRD-positive tumours in the EU.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumours. Women treated with Lynparza in combination with bevacizumab in the PAOLA-1 Phase III trial lived progression free for a median of more than three years, showing that HRD testing should be an essential component of clinical diagnosis. HRD status can help physicians select a personalised 1st-line treatment regimen for patients to substantially delay relapse in this devastating disease.

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: Biomarker testing has rapidly enhanced our understanding of how PARP inhibition can help target this disease. The EU approval reinforces that HRD-positive tumours represent a distinct subset of advanced ovarian cancer and HRD testing is critical for women in this setting.

The PAOLA-1 Phase III trial showed thatLynparza,in combination with bevacizumab maintenance treatment, reduced the risk of disease progression or death by 67% (based on a hazard ratio of 0.33; 95% confidence interval 0.25-0.45). The addition ofLynparzaimproved PFS to a median of 37.2 months versus 17.7 with bevacizumab alone in patients with HRD-positive advanced ovarian cancer. The data from the PAOLA-1 trial was published inThe New England Journal of Medicinein 2019.

Further results recently presented at the European Society for Medical Oncology Virtual Congress 2020 showed a statistically significant improvement in the key secondary endpoint of the time to second disease progression (PFS2). Lynparza with bevacizumab provided benefit beyond first disease progression, improving PFS2 to a median of 50.3 months versus 35.3 with bevacizumab alone.

The full EU indication is for Lynparza in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with HRD positive status defined by either a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation and/or genomic instability.

Lynparzain combination with bevacizumab isapproved in the USand in several other countries as a 1st-line maintenance treatment for patients with HRD-positive advanced ovarian cancer and is currently under regulatory review in other countries around the world.

Financial considerations

Following this approval for Lynparza in the EU, AstraZeneca will receive a regulatory milestone payment from MSD of $25m, anticipated to be booked as collaboration revenue during the fourth quarter of 2020.

Ovarian cancer

In 2018, there were nearly 68,000 new cases of ovarian cancer diagnosed in the EU and around 45,000 deaths.3Approximately 50% of ovarian cancers are HRD-positive including BRCA1/2 mutation.4,5Approximately 15% of ovarian cancers have a BRCA1/2 mutation.6 The primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission.7-9

Homologous recombination deficiency

HRD, which defines a subgroup of ovarian cancer, encompasses a wide range of genetic abnormalities, including BRCA mutations and beyond. As with BRCA gene mutations, HRD interferes with normal cell DNA repair mechanisms and confers sensitivity to PARP inhibitors including Lynparza.10

PAOLA-1

PAOLA-1 is a double-blinded Phase III trial testing the efficacy and safety ofLynparzaadded to standard-of-care bevacizumab versus bevacizumab alone, as a 1st-line maintenance treatment for newly diagnosed advanced FIGO Stage III-IV high-grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy and bevacizumab.AstraZeneca and MSD announced in August 2019 that the trial met its primary endpoint of PFS in the overall trial population.

Lynparza

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR), such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.

Lynparza is currently approved in a number of countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer. It is approved in the US, the EU, Japan, China, and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in the US as a 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced ovarian cancer (BRCAm and/or genomic instability). Lynparza is approved in the US, Japan, and a number of other countries for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. It is also approved in the US, the EU and several other countries for the treatment of germline BRCAm metastatic pancreatic cancer. Lynparza is approved in the US for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (BRCAm and other HRR gene mutations). Regulatory reviews are underway in several countries for ovarian, breast, pancreatic and prostate cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 30,000 patients worldwide. Lynparza has the broadest and most advanced clinical trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZeneca's industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the worlds first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio ofnew medicines that has the potential to transform patients lives and the Companys future. With seven new medicines launched between 2014 and 2020, and a broad pipelineof small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of four scientific platforms Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

References

1. EuroHealth. (2018). Ovarian Cancer: The Silent Killer. Available at: https://eurohealth.ie/policy-brief-women-and-ovarian-cancer-in-the-eu-2018/ [Accessed October 2020].

2. ECIS. (2020).Estimates of cancer incidence and mortality in 2020, for all cancer sites. Available here [Accessed October 2020].

3. The World Health Organization. IARC. Globocan. (2018). Available at: http://gco.iarc.fr/ [Accessed October 2020].

4. Moschetta et al. (2016). BRCA somatic mutations and epigenetic BRCA modifications in serous ovarian cancer. Annals of Oncology, 27(8), pp.1449-1455.

5. Bonadio et al. (2018). Homologous recombination deficiency in ovarian cancer: a review of its epidemiology and management. Clinics, 73(Suppl 1): e450s.

6. Ramus. (2009). The Contribution of BRCA1 and BRCA2 to Ovarian Cancer. Molecular Oncology, 3(2), pp.138150.

7. Raja et al. (2012). Optimal first-line treatment in ovarian cancer. Annals on Oncology. 23 Suppl 10, x118-127.

8. NHS Choices, Ovarian Cancer Available at: https://www.nhs.uk/conditions/ovarian-cancer/treatment/ [Accessed October 2020].

9. Ledermann et al. (2013). Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology, 24, pp.vi24-vi32.

10. Moore, K. (2018). Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. New England Journal of Medicine, 379(26), pp.2495-2505.

SOURCE: AstraZeneca

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Lynparza approved in the EU as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer | Small Molecules | News...

Predictive Biomarkers Market Growth Sales Revenue Analysis 2020-2025 – The Think Curiouser

This report also researches and evaluates the impact of Covid-19 outbreak on the Predictive Biomarkers industry, involving potential opportunity and challenges, drivers and risks. We present the impact assessment of Covid-19 effects on Predictive Biomarkers and market growth forecast based on different scenario (optimistic, pessimistic, very optimistic, most likely etc.).

Global Predictive Biomarkers Market Overview:

The research report, titled [Global Predictive Biomarkers Market 2020 by Company, Regions, Type and Application, Forecast to 2025], presents a detailed analysis of the drivers and restraints impacting the overall market. Analysts have studied the key trends defining the trajectory of the market. The research report also includes an assessment of the achievements made by the players in the global Predictive Biomarkers market so far. It also notes the key trends in the market that are likely to be lucrative. The research report aims to provide an unbiased and a comprehensive outlook of the global Predictive Biomarkers market to the readers.

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Global Predictive Biomarkers Market: Segmentation

For clearer understanding of the global Predictive Biomarkers market, analysts have segmented the market. The segmentation has been done on the basis of application, technology, and users. Each segment has been further explained with the help of graphs figures. This breakdown of the market gives the readers an objective view of the global Predictive Biomarkers market, which is essential to make sound investments.

segment by Type, the product can be split into Hormone Therapy Immunotherapies Targeted Therapy Monoclonal Antibody Therapy Gene Therapy

Market segment by Application, split into Hospitals Diagnostic Centers Oncology Clinics Research Institutes

Based on regional and country-level analysis, the Precision Cancer Therapies market has been segmented as follows: North America United States Canada Europe Germany France U.K. Italy Russia Nordic Rest of Europe Asia-Pacific China Japan South Korea Southeast Asia India Australia Rest of Asia-Pacific Latin America Mexico Brazil Middle East & Africa Turkey Saudi Arabia UAE Rest of Middle East & Africa

To understand the changing political scenario, analysts have regionally segmented the market. This gives an overview of the political and socio-economic status of the regions that is expected to impact the market dynamic.

Global Predictive Biomarkers Market: Research Methodology

To begin with, the analysis has been put together using primary and secondary research methodologies. The information has been authenticated by market expert through valuable commentary. Research analysts have also conducted exhaustive interviews with market-relevant questions to collate this research report.

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Global Predictive Biomarkers Market: Competitive Rivalry

The research report also studied the key players operating in the global Predictive Biomarkers market. It has evaluated and elucidated the research and development statuses of these companies, their financial outlooks, and their expansion plans for the forecast period. In addition, the research report also includes the list of strategic initiatives that clearly explain the achievements of the companies in the recent past.

In the competitive analysis section of the report, leading as well as prominent players of the global Precision Cancer Therapies market are broadly studied on the basis of key factors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on price and revenue (global level) by player for the period 2015-2020. The key players covered in this study Abbott Laboratories Bayer HealthCare GlaxoSmithKline OncoGenex Pharmaceuticals Hospira Boehringer Ingelheim AstraZeneca Aveo Pharmaceuticals

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Strategic Points Covered in TOC:

Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Predictive Biomarkers market

Chapter 2: Evaluating the leading manufacturers of the global Predictive Biomarkers market which consists of its revenue, sales, and price of the products

Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales

Chapter 4: Presenting global Predictive Biomarkers market by regions, market share and with revenue and sales for the projected period

Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

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Predictive Biomarkers Market Growth Sales Revenue Analysis 2020-2025 - The Think Curiouser

Retinitis Pigmentosa (Retinitis) Market Report 2020 (COVID-19 Impact Analysis) By Segmentations, Key Company Profiles & Demand Forecasts to 2020 …

A recent market research report added to repository of Credible Markets is an in-depth analysis of Global Retinitis Pigmentosa (Retinitis) Market. On the basis of historic growth analysis and current scenario of Retinitis Pigmentosa (Retinitis) market place, the report intends to offer actionable insights on global market growth projections. Authenticated data presented in report is based on findings of extensive primary and secondary research. Insights drawn from data serve as excellent tools that facilitate deeper understanding of multiple aspects of global Retinitis Pigmentosa (Retinitis) market.

This report examines all the key factors influencing growth of global Retinitis Pigmentosa (Retinitis) market, including demand-supply scenario, pricing structure, profit margins, production and value chain analysis. Regional assessment of global Retinitis Pigmentosa (Retinitis) market unlocks a plethora of untapped opportunities in regional and domestic market places. Detailed company profiling enables users to evaluate company shares analysis, emerging product lines, scope of NPD in new markets, pricing strategies, innovation possibilities and much more.

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Key Companies Sanofi Amgen Amarantus Bioscience Holdings Acucela Applied Genetic Technologies Corp Asklepios BioPharmaceutical Astellas Pharma Caladrius Biosciences Dompe Farmaceutici SpA Dormant Projects GenSight Biologics SA Grupo Ferrer Internacional SA ID Pharma InFlectis BioScience Ionis Pharmaceuticals Mimetogen Pharmaceuticals Ms Science Corp Nanovector srl Novartis AG Novelion Therapeutics ProQR Therapeutics ReNeuron Group Plc SanBio Shire (Takeda Pharmaceutical) Spark Therapeutics Market by Type General Treatment Traditional Chinese Medicine Gene Therapy The Surgical Treatment Others Market by Application Hospitals Eye Clinics Others

By Region

Asia-Pacific[China, Southeast Asia, India, Japan, Korea, Western Asia]

Europe[Germany, UK, France, Italy, Russia, Spain, Netherlands, Turkey, Switzerland]

North America[United States, Canada, Mexico]

Middle East & Africa[GCC, North Africa, South Africa]

South America[Brazil, Argentina, Columbia, Chile, Peru]

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Some Points from Table of Content

Global Retinitis Pigmentosa (Retinitis) Market Status (2015-2019) and Forecast (2020-2025) by Region, Product Type & End-Use

Chapter 1 Market Overview

Chapter 2 Key Companies

Chapter 3 Global Market Status and Future Forecast

Chapter 4 Asia-Pacific Market Status and Future Forecast

Chapter 5 Europe Market Status and Future Forecast

Chapter 6 North America Market Status and Future Forecast

Chapter 7 South America Market Status and Future Forecast

Chapter 8 Middle East & Africa Market Status and Future Forecast

Chapter 9 Market Features

9.1 Product Features

9.2 Price Features

9.3 Channel Features

9.4 Purchasing Features

Chapter 10 Investment Opportunity

10.1 Regional Investment Opportunity

10.2 Industry Investment Opportunity

Chapter 11 Coronavirus Impact

11.1 Impact on Industry Upstream

11.2 Impact on Industry Downstream

11.3 Impact on Industry Channels

11.4 Impact on Industry Competition

11.5 Impact on Industry Obtain Employment

Chapter 12 Conclusion

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Points Covered in the Report

The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.

The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 12 years data history and forecast.

The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.

Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.

The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Impact of Covid-19 in Retinitis Pigmentosa (Retinitis) Market:Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost every country around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Retinitis Pigmentosa (Retinitis) market in 2020. The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor/outdoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.

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Thanks for reading this article you can also get individual chapter wise section or region wise report version like North America, Europe, MEA or Asia Pacific.

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Retinitis Pigmentosa (Retinitis) Market Report 2020 (COVID-19 Impact Analysis) By Segmentations, Key Company Profiles & Demand Forecasts to 2020 ...

Hyperbaric Oxygen Therapy (HBOT)Market: Is Covid19 testing the healthcare industry? – PRnews Leader

The rise in prevalence of chronic diseases worldwide is propelling the global hyperbaric oxygen therapy market size growth says Fortune Business Insights in their new study. The study is titled Hyperbaric Oxygen Therapy (HBOT)Market Size, Share and Global Trend By Product (Monoplace oxygen chambers, Multiplace oxygen chambers, Topical oxygen chambers, Portable oxygen chambers), By Application (Decompression Sickness, Wound Healing, Infectious diseases, Gas Embolism, Carbon monoxide poisoning, Others), By End Users (Hospitals, Ambulatory care centers, Outpatient clinics, Standalone hyperbaric treatment centers) and Geography Forecast 2026.

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Coronavirus Outbreak: C-Arms Industry Fights Back with Well-defined Business Strategies – PRnews Leader

As chronic diseases become more widespread, the global C-arms market is expected to grow considerably during the forecast period. Fortune Business Insights shares valuable market analysis in its report, titled C-arms Market Size, Share and Global Trend By Size (Mini C-arms, Compact C-arms, Full-size C-arms, Others), By Application (Cardiology, Urology, Neurology, Orthopaedics, Others), By Type (Fixed, Mobile), By Technology (Image Intensifiers, Flat Panel Detectors), By End User (Hospitals, Specialty Clinics, Diagnostics & Imaging Centers, Others), and Geography Forecast till 2026. The report also incorporates a comprehensive evaluation of emerging market trends and factors that will impact the market.

The report covers:

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Leading Players operating in the C-Arms Market are:

Key players are involved in mergers and acquisition to strengthen their market position. Owing to increasing competition frequent innovations are taking place in the market. Some of the companies operating the industry are:

Segmentation of the Global C-arms Market

By Size

By Application

By Type

By Technology

By End User

By Geography

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The good news about breast cancer – The Gazette

By Maggie Ireland, for The Gazette

October as Breast Cancer Awareness Month shines a spotlight on the battle against breast cancer and the developments in diagnosing and treating the disease that inspire hope for the future.

Breast cancer remains very common. Its still the most common cancer in women, said Dr. Ingrid Lizarraga, a clinical associate professor of surgery and breast surgeon at the University of Iowa Hospitals and Clinics in Iowa City.

But it is no longer the most common cause of death for women it is now the second most common cause of cancer death for women after lung cancer. We know a lot

more about breast cancer than we ever did before. The vast majority of women who have breast cancer will do great.

Admittedly, a breast cancer prognosis largely depends on the type of breast cancer you have and the stage at which it is diagnosed. The good news is that the prognosis has improved considerably over the years.

Mortality rates are decreasing, thanks to improved screenings and improved treatment, said Dr. Rasa Buntinas, an oncologist at PCI in Cedar Rapids. At our cancer center, 80 percent of women are diagnosed at an early stage stage 0 or stage 1 and that means a better chance of survival.

More screening options have become available in recent years.

Mammograms are still what we recommend, Lizarraga said. 3-D mammograms have been around for about five years and can be really helpful for women with dense

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breasts. The recognition that breast density affects how you screen is important. Whole breast ultrasounds can also be useful.

For women with abnormal findings, a breast MRI is an option.

Discussing your personal risk factors with your doctor is the best way to determine what screenings are best for you.

The latest developments in genetic testing can further pinpoint specific risk factors.

Weve identified a set of genes that puts you at high risk for developing breast cancer, and we can test for this gene, Lizarraga said. The trick is to find those at risk who need the genetic testing. If you have concerns, talk to your doctor so they can assess your risk and give you better guidance on a screening regimen.

Today, the widely accepted recommendation is for most women to begin getting an annual mammogram at age 40.

If you have any risk factors at all, start at 40. But the latest you should start is at age 45. And you should screen every year, Lizarraga said. When youre younger, the odds are lower, but the stakes are higher.

In the past, all women were encouraged to do a monthly self-exam, but thats no longer the case.

Self-exams are no longer recommended, Buntinas said. They tended to lead to more testing and biopsies but really didnt improve outcomes. The recommendation now

is breast self-awareness. Be aware of how your breasts look and feel, and report changes to your doctor.

Lizarraga agrees that a woman should trust her instincts if she senses something is wrong.

You know your body better than anyone else, she said. It doesnt just have to be a lump it could be a different appearance of the skin or the nipple. Pay attention to how you feel and how you look, and advocate for yourself if you notice something.

Many developments have been made in treating breast cancer, particularly metastatic breast cancer, Buntinas said.

Were really getting a much better understanding of tumor biology, she said. Specific targets are being identified to better improve treatments and provide more of a personalized medicine approach. In practice, these treatments are really improving survival.

Its an exciting time in the treatment of breast cancer, Lizarraga said, because things pretty much change every day.

If a woman needs a mastectomy, we can give you a result that looks much closer to what your native breast looks like, she said. The attitude used to be that you shouldnt worry about how it looks, because you should be grateful you dont have cancer, but thats not accepted anymore.

Advancements also are being made in addressing the side effects of treatment, like lymphedema, the swelling of a womans arm or hand that can follow the removal of lymph nodes.

Weve gotten better at figuring out more effective techniques that result in less lymphedema, Lizarraga said. Were also now better able to save a womans breasts if she prefers to do that.

The biggest advances in treatment, however, have been in systemic therapies, or the use of drugs to reach cancer cells anywhere in the body, she said.

Almost all women with breast cancer will get some form of systemic treatment pills or therapy.

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Weve become increasingly targeted with treatment, Lizarraga said. We start by figuring out which type of breast cancer you have. We now have genomic tests, so we can test the DNA of the tumor itself to see how likely it is to recur. That actually allows us to figure out whether a woman will benefit from chemotherapy or not.

Thats huge because we can limit the toxic treatment when its not going to be beneficial.

Treatment is more targeted than ever.

We match severity of treatment to the severity of disease, Lizarraga said. Weve figured out how to make things more personal in a lot of cases, weve changed the timing of treatment. In the past, you often came in, had surgery and then began the next form of treatment, like chemotherapy or pills.

Now, we often provide treatment before surgery and then personalize what is needed next.

Lizarraga said women of all ages need to know breast cancer is common but treatable, as long as its caught early.

If you do have a family history, be sure to get evaluated to see if genetic testing is appropriate, she said.

And know that who treats you is important, too.

Get a second opinion make sure the person youre seeing is someone who knows specifically about breast cancer treatment and the latest developments. Advocate for

yourself.

Both doctors agree the prognosis for breast cancer patients is brighter than ever.

The outlook is very positive and hopeful for the future, Buntinas said.

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The good news about breast cancer - The Gazette