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Doctor has seen a surge in men asking for penis injections – Metro.co.uk

Dr Shirin Lakhani says she receives five enquiries a day about penis injections (Picture: Getty/Metro.co.uk

Could time in lockdown be upping the pressure for men to last longer in bed and have rock-hard erections at a moments notice?

A leading intimate health specialist and doctor, Dr Shirin Lakhani, says shes seen a dramatic rise in enquiries for her P-shot procedure a treatment that sees blood injected into the penis since lockdown came into place.

She reckons this may be down to all the stress of the pandemic from lost income to health-related anxieties causing erectile issues and other struggles in bed, along with dips in sex drives.

But she also believes that all the time cooped up at home might allow previously hidden sexual issues to become apparent to the persons partner.

As a result, Dr Lakhani has seen a huge increase in the number of men getting in touch to ask about her treatment, receiving five enquiries a day since lockdown began.

The P-shot procedure, also known as the Priapus Shot, involves injecting the penis with a patients own platelet rich plasma, which its thought can stimulate the growth of new tissue and increase blood flow, thus strengthening erections and enhancing the peniss appearance, too.

Its similar to the vampire facial youve likely heard about except the needle is going into your penis instead of your face.

The treatment costs 1,200, so yes, its on the pricey side.

A lot of the men Im hearing from have struggled with sexual intercourse for years but have until now managed to hide the fact that they are unable to get an erection or cant ejaculate, says Dr Lakhani. Before lockdown they managed to hide their problem behind the fact that they were tired from work or because they were physically away a lot due to work.

Now though with the country stuck in lockdown problems such as these are impossible to ignore.

Once upon a time sexual dysfunction, or the difficulty by an individual or couple during any normal sexual activity, including pleasure, desire, preference, arousal or orgasm, was very much a taboo subject.

At times like this people are turning to social media more and beginning to realise how many options there are out there to help treat sexual dysfunction. And with studies showing that at least a third of us have experienced these types of problems at some point in our lives, its certainly widespread.

The P-shot is among a large swell in cosmetic procedures aimed squarely at boosting mens genitals, from one type of injection that a surgeon claims can increase the size of a penis by two inches to the trend for getting filler to make the testicles larger.

If you do choose to go down the route of injections or other cosmetic treatments, remember that these are medical treatments that need to be done by a professional in a safe and sanitised setting. Just because were talking about injections rather than in-depth surgery doesnt mean the risks disappear, and getting shots from a dodgy practitioner could leave you with far more severe penis problems than you started with.

But while such cosmetic treatments could help to tweak certain parts of a mans appearance and sexual performance, its vital to explore all options before rushing into any procedure.

Longterm difficulties getting or maintaining an erection can be caused by all sorts of factors, including depression, stress, heart disease, and high cholesterol all of which need addressing by a medical professional.

If erectile dysfunction is a symptom of another issue, its crucial to talk to your GP to get to the root of the problem rather than just tackling one more obvious way an illness might be rearing its head.

Plus, you could end up saving yourself time, pain, and money by figuring out a more obvious cause and solution for problems in the bedroom reducing your stress levels and improving communication with your partner are both free, FYI.

The main thing is that in this day and age no man should suffer these symptoms in silence, says Dr Lakhani. They can not only impact on a man physically but also over a prolonged period of time place a huge pressure on mental health.

Being comfortable in your own skin is a major factor in promoting sexual health. Its not about being perfect, its about body confidence, good health and communication with your partner.

Many men and women dont talk about their intimate health and find it embarrassing to seek help but it doesnt have to be a taboo subject.

We should feel comfortable enough to talk about the issues we experience with intimate health and everyone should be allowed to enjoy sex.

Do you have a story to share? Get in touch by emailing MetroLifestyleTeam@Metro.co.uk.

Share your views in the comments section below.

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Doctor has seen a surge in men asking for penis injections - Metro.co.uk

Creating hairy human skin: Not as easy as you think – Science Codex

For more than 40 years, scientists and commercial companies have been recreating human skin in laboratories around the world. Yet all of these products lack important aspects of normal skin--hair, nerves, and fat.

In new research, cultured human skin cells embedded with fat and nerves and capable of growing hair are a reality. The achievement represents more than five years of study that started in the laboratory of Karl Koehler, PhD (then at Indiana University School of Medicine) and completed in Koehler's new laboratory at Boston Children's Hospital in the departments of otolaryngology and communication enhancement and plastic and oral surgery research. The technique appears in a paper published this week in Nature.

"In this latest work, we discovered a way to grow both layers of human skin together," says Koehler, referring to the top and bottom layers of human skin (the epidermis and dermis, respectively). "Those cells talk to each other in a skin organoid culture - or skin in a dish we created - and sprout hair follicles accompanied by fat cells and neurons."

Taking the discovery a step further, the team transplanted the human hairy skin into mice. The mice eventually sprouted human hair follicles at the site of transplantation. Potential applications include testing cosmetics, drugs, and burn treatments.

Skin in a dish includes mini organs

Skin in a dish models are not new. And like many, Koehler and his colleagues thought that the challenge of growing fully functional, hairy skin cells, had long been solved. Skin cells are some of the first cells to have been grown in cultures outside of the body and incubator.

But the skin that people make in a dish never has mini organs or appendages, like hair follicles or sweat glands, embedded in the skin. These mini organs are important for heat regulation, touch sensation, and appearance.

In 2018, the team published a paper showing they could generate hairy skin from mouse stem cells. To create human hairy skin cells, the team started with human induced pluripotent stem cells, which are human adult skin cells that are coaxed back to an embryonic form.

"So we applied a cocktail of growth factors and small molecules, kind of a cooking recipe for human pluripotent stem cells," says Koehler.

The team first noticed co-development of skin epidermis and the dermis. The interaction and signaling between the two tissue layers led to budding of hair follicles at 70 days, which lines up well with the timing of hair development in the human fetus.

In addition to growing hair, the organoids produce fat and muscle-like cells of the skin, as well as, nerves similar to those that mediate touch sensation. "The fat is an unsung hero of the skin and recent studies suggest it plays a critical role in wound healing," says Jiyoon Lee, PhD, first-author on the paper and research associate in the department of otolaryngology at Boston Children's Hospital.

The organoids also produce Merkel cells, specialized touch responsive cells of the skin that have also been implicated in diseases such as Merkel cell carcinoma. "The inclusion of these other cell types likely expands the potential uses of the skin organoid model to research on sensory disorders and cancer," she adds.

Mice grew pigmented human hairs

To see if the technique worked in a living animal, the team cultured the organoids for over four months and then implanted them on the back of mice specially developed not to reject the grafts. "We noticed that within a month, tiny brown hairs sprang up from the transplant site," explains Lee. "This showed us, amazingly, that pigment cells also developed in the organoids."

They compared the transplanted skin with adult human skin samples observing several unique features of human skin in the transplants. One includes 'rete ridges' or valleys in the wavy pattern of human epidermis that helps anchor it into skin membranes. And, the transplanted hair developed elaborate sebaceous glands that produced sebum, the natural oil that lubricates human skin.

An unexpected and fortuitous discovery

This new discovery is literally an outgrowth of work Koehler began at Indiana University when working on a system of recapitulating the inner ear. His goal at the time was to create cells that sense auditory stimuli - sound - to model hearing loss disorders and test gene therapies for hearing loss and balance disorders.

There, he manipulated human induced pluripotent stem cells with the same cocktail of chemicals and proteins used during normal embryonic development guiding them to become inner ear structures.

In the production of this technique, as the inner ear cells were budding during early development, the team found that skin tissue formed as a byproduct.

"This was surprising and we initially tried to get rid of the skin tissue, thinking it was a pesky off-target tissue, like a weed in a garden," recalls Koehler. "Once we saw the scientific value of growing hairy skin in dish, we switched tactics, trying to eliminate the inner ear organoids in favor of growing skin."

In their purification attempts, they discovered that the skin tissue contained both layers of skin, epidermis and dermis. In culture, the skin formed outgrowing hair follicles.

A proof of concept

Translating any mouse study into humans is a long road. "But we think we have developed a proof of concept showing that the cells integrate into skin and form outgrowing hair follicles," says Koehler.

The team hopes that in the long term, they can use the technology to seed wound beds with cultured skin to reconstruct skin, such as in the case of extensive burns or scars.

And while it might be tempting to think of the approach as a "cure" for baldness, Koehler cautions that many challenges lay ahead. "We now have a technique that could generate nearly unlimited hair follicles for transplantation" he says. "But immune rejection is a major hurdle and generating follicles tailored to an individual will be incredibly costly and take a year or more." To meet these challenges, the team is working on ways to accelerate development in a dish, engineer organoids to evade immune detection, or produce similar skin organoids from adult patient-derived cells.

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Creating hairy human skin: Not as easy as you think - Science Codex

Ide-cel Appears Active in Almost Three-Fourths of Heavily Pretreated Patients with Myeloma – Cancer Network

Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeting CAR T-cell therapy, yielded a response in73% of patients with heavily pretreated relapsed/refractory multiple myeloma, according to topline findings from the pivotal phase 2 KarMMA trial shared during the 2020 ASCO Virtual Scientific Program.

In the study, 33% of patients had a complete response with ide-cel. The median duration of response (DOR) was 10.7 months, and the median progression-free survival (PFS) was 8.8 months (95% CI, 5.6-11.6).

Ide-cel demonstrated frequent, deep, and durable responses in heavily pretreated, highly relapsed/refractory patients with myeloma, said Nikhil C. Munshi, MD, director of Basic and Correlative Science, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, professor of Medicine, Harvard Medical School. Overall, ide-cel provides an attractive option for the treatment of patients with triple-class exposed relapsed/refractory myeloma.

In March 2020, Bristol Myers Squibb and bluebird bio, Inc., the codevelopers of ide-cel, submitted a Biologics License Application (BLA) to the FDA for the use of the CAR T-cell therapy as a treatment for adult patients with multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

However, earlier this month, the FDA issued a Refusal to File letter to the companies regarding the BLA. In its initial review, the agency concluded that additional information was needed for the Chemistry, Manufacturing and Control module of the BLA. The FDA did not ask for any further clinical or nonclinical data according to the companies, which plan to resubmit the application by the end of July of this year.

The phase 2 KarMMA trial (NCT03361748) included 128 patients with relapsed/refractory multiple myeloma who received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

The median age was 61 months (range 33-78), 35% of patients had high-risk cytogenetics, 51% had high tumor burden, 39% had extramedullary disease, and 85% had 50% tumor BCMA expression. ECOG performance status was 0 (45%), 1 (53%), or 2 (2%). R-ISS disease stage was I (11%), 2 (70%), or III (16%). Patients had received a median of 6 (range, 3-16) prior antimyeloma regimens.

Ninety-four percent of patients had received 1 prior autologous stem cell transplant, and 34% had received more than 1. Eighty-eight percent of patients received bridging therapies during CAR T-cell manufacturing; however, only 4% of patients responded to the treatment. Regarding refractory status, 94% of patients were refractory to anti-CD38 antibodies and 84% were triple refractory.

Patients were treated at CAR+ T cell doses of 150 x 106 (n = 4), 300 x 106 (n = 70), or 450 x 106 (n = 54). The median follow-up was 18 months, 15.8 months, and 12.4 months, respectively. Across all patients, the median follow-up was 13.3 months. The primary end point was ORR, with secondary end points including CR, DOR, PFS, overall survival (OS), and quality of life.

Across all patients, the 73% ORR (95% CI, 65.8-81.1; P <.0001) included a 33% CR rate (95% CI, 24.7-40.9; P <.0001), a 20% very good partial response rate, and a 21% partial response rate. The overall CR rate comprised 26% of patients who achieved a CR/stringent CR (sCR) and were minimal residual disease (MRD)-negative, and 7% of patients who achieved a CR/sCR but who did not have MRD data. The median time to first response was 1 month (range, 0.5-8.8) and the median time to CR was 2.8 months (range, 1-11.8).

Durable responses were observed across all doses, said Munshi. At the dose of 450 x 106 CAR+ T cells, the ORR was 82% and the CR/sCR rate was 39%.

Clinically meaningful efficacy in terms of ORR was observed across subgroups, irrespective of age, risk categorization, tumor burden, BCMA expression level, extramedullary disease, triple-refractory status, penta-refractory status, and bridging therapy.

PFS increased as the target dose increased. At the 450 x 106 CAR+ T-cell dose, the median PFS was 12.1 months (95% CI, 8.8-12.3). The median PFS also increased by depth of response with a median of 20.2 months (95% CI, 12.3not evaluable) among patients who achieved a CR/sCR.

Munshi said the survival data are immature. At the time of the analysis, the median OS was 19.4 months (95% CI, 18.2not evaluable) and the 1-year OS rate was 78%.

Cytokine release syndrome (CRS) frequency increased with dose but was mostly low-grade, said Munshi. Overall, 84% of patients had 1 CRS event, with the majority (78%) being grade 1/2. There were 5 cases of grade 3 CRS, 1 case of grade 4, and 1 case of grade 5. The median time to onset of CRS was 1 day (range, 1-12), and the median duration of CRS was 5 days (range, 1-63). Fifty-two percent of patients received tocilizumab (Actemra) for CRS management, and 15% of patients received corticosteroids.

Neurotoxicity was mostly low grade and was similar across target doses, said Munshi. Overall, 18% of patients had 1 neurotoxicity event. There were 19 cases of grade 1/2 neurotoxicity and 4 cases of grade 3. There were no grade 4 or 5 incidents. The median time to onset of neurotoxicity was 2 days (range, 1-10), and the median duration was 3 days (range, 1-26). Two percent of patients received tocilizumab for neurotoxicity, and 8% of patients received corticosteroids.

The other significant adverse event, according to Munshi, was cytopenia91% of patients had any grade neutropenia (89% grade 3), and 63% (52% grade 3) had any grade thrombocytopenia. The median time to recovery of grade 3 neutropenia and thrombocytopenia was 2 months and 3 months, respectively, said Munshi.

There were 5 deaths within 8 weeks of ide-cel infusion2 following myeloma progression and 3 from AEs (CRS, aspergillus pneumonia, and GI hemorrhage). There was also 1 other AE-related death (CMV pneumonia) that occurred within 6 months, in the absence of myeloma progression.

Reference:

Munshi NC, Anderson Jr LD, Jagannath S, et al. Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T-cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): Initial KarMMa results. Presented at: 2020 ASCO Virtual Scientific Program; May 29-31, 2020. Abstract 8503.

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Ide-cel Appears Active in Almost Three-Fourths of Heavily Pretreated Patients with Myeloma - Cancer Network

FTC Sends Wave of Warning Letters to Stop Unsupported Claims Products and Therapies Effectively Prevent or Treat COVID-19 – MyChesCo

WASHINGTON, D.C. The Federal Trade Commission announced it has sent letters warning 35 more marketers nationwide to stop making unsubstantiated claims that their products and therapies can treat or prevent COVID-19, the disease caused by the novel coronavirus.

This is the sixth set of warning letters the FTC has announced as part of its ongoing efforts to protect consumers from health-related COVID-19 scams. In all, the Commission has sent similar letters to more than 160 companies and individuals.

Most of the letters announced this week target treatments offered in clinics or medical offices, including intravenous (IV) Vitamin C and D infusions, supposed stem cell therapy, and vitamin injections that may at first glance appear to be based in medicine or proven effective. However, currently there is no scientific evidence that these, or any, products or services can treat or cure COVID-19.

The FTC sent the letters to the companies and individuals listed below. The recipients are grouped based on the type of therapy, product, or service they pitched as preventing or treating COVID-19.

Intravenous (IV) and Ozone Therapies, Immunity Boosting Injections:

Stem Cell Treatments:

Electromagnetic Field Blocking Patches:

Essential Oils:

Homeopathic Treatments:

Vitamins, Supplements, Silver, and Chinese Herbal Treatments:

In the letters, the FTC states that one or more of the efficacy claims made by the marketers are unsubstantiated because they are not supported by scientific evidence, and therefore violate the FTC Act. The letters advise the recipients to immediately stop making all claims that their products can treat or cure COVID-19, and to notify the Commission within 48 hours about the specific actions they have taken to address the agencys concerns.

The letters also note that if the false claims do not cease, the Commission may seek a federal court injunction and an order requiring money to be refunded to consumers. In April, the FTC announced itsfirst case against a marketer of such products, Marc Ching, doing business as Whole Leaf Organics.

The FTC worked in coordination with the Office of the Texas Attorney General in issuing the warning letter to Hot Springs Biofeedback, and appreciates its assistance.

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FTC Sends Wave of Warning Letters to Stop Unsupported Claims Products and Therapies Effectively Prevent or Treat COVID-19 - MyChesCo

Sickle cell treatment then and now – SCNow

Five years ago, we had only one treatment for sickle cell disease, a disease that should not be taken lightly.

This disease can be a pain-generating disease that actually affects all organs of the body. This can start at the heart, blood vessels, brain, joints, bones and also the lungs.

Sickle cell is due to a mutation of a tiny gene that leads to an unstable hemoglobin. The sickles in the hemoglobin, when stressed, deprive tissue from oxygen that can lead to what we call crisis.

Crisis starts with pain, but it can also lead to stroke, heart attack and limb loss. Sickle cell crisis is when the abnormal cell gets stuck in the small blood vessels.

Sickle cell disease affects approximately 100,000 people in the United States. For years, the only therapeutic option was Hydroxyurea. This drug has been in existence since 1984. We know that this drug works, since it has proved to be effective in increasing hemoglobin, reducing pain and acute chest syndrome.

This drug has also decreased the number of blood transfusions in patients who suffer from sickle cell disease. Unfortunately, Hydroxyurea is chemotherapy and requires close monitoring. This therapy works over time with each patient; therefore, not all patients will respond equally. Since Hydroxyurea was introduced, there has been a need for new treatments. For the past several years, more therapies have started to emerge.

The first notable drug that has been FDA approved in 2017, since Hydroxyurea, is L-glutamine (Endari). This drug works on the inflammatory part of the disease. It has also proved to decrease the number of pain crisis and lessen acute chest syndrome.

The second drug is Voxelotor. This drug is a once-daily pill that stabilizes the oxygenated hemoglobin. Trials have proved to make patients less anemic, but events are not necessarily less painful. More long-term studies are looking at this issue. This drug is available, and FDA approved, through an accelerated program.

The third drug is Crizanlizumab. This drug helps with the stickiness of the red blood cells against the sticky vessel wall. This is one of the detrimental aspects of this disease. A randomized study called SUSTAIN proved that this intravenous drug decreases the number of painful crisis. This drug was FDA approved through a breakthrough therapy program.

Lastly, there is gene therapy. This type of treatment consists of an auto stem cell transplant of a viral infected, anti-sticking hemoglobin. This therapy still requires chemotherapy to wipe out the bone marrow so that space can be made for the transplant. The results of this treatment have been very successful.

Many promising therapies are seeing the light and are changing the care of this complex disease so that patients with sickle cell disease can lead a semi-normal lifestyle.

Dr. Ziad Skaff is board certified in hematology and oncology. He serves as chief of staff of MUSC Health-Florence Medical Center and Medical Director of Oncology Services. Dr. Skaff is associated with MUSC Health Hematology & Oncology, located at 805 Pamplico Highway, Medical Pavilion A, Suite 315. To schedule an appointment, call 843-674-6460.

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Sickle cell treatment then and now - SCNow

Cirmtuzumab Added to Ibrutinib Induces Responses in R/R MCL and CLL – Targeted Oncology

Compelling objective responses and safety results were demonstrated with the combination of cirmtuzumab (UC-961) and ibrutinib (Imbruvica) in cohorts of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL), who were treated in the phase 1b/2 clinical trial (NCT03088878).1

A group of investigators led by Hun Ju Lee, MD, hypothesized that cirmtuzumab/ibrutinib would increase activity, deepen responses, and extend the durability of responses compared to ibrutinib alone based on the mechanism of action of cirmtuzumab, a monoclonal antibody that addresses re-expressed ROR1 in hematologic malignancies and solid tumors. As a single agent, cirmtuzumab led to antitumor activity in an earlier study and it was suggested that the drug could be additive to the effects of Brutons tyrosine kinase (BTK) inhibitors. It was also hypothesized that the addition of cirmtuzumab to ibrutinib would not interfere with the tolerable safety profile of either agent.

The study enrolled patients with relapsed/refractory (r/r) MCL or r/r CLL and small lymphocytic leukemia (SLL) who had measurable disease and little or no prior exposure to BTK inhibitor therapy. Overall, the study included 46 patients, 12 of whom were evaluable to be enrolled in the MCL cohort and 34 evaluable for the CLL/SLL cohort. At baseline, the MCL cohort showed a median of 2.5 prior treatment regimens (range, 1.0-5.0). The prior regimens consisted of chemotherapy, biologics, PI3K/BCL-2 inhibitors, stem cell transplant, and chimeric antigen receptor (CAR) T-cell therapy. In the CLL/SLL cohort, the median number of prior regimens was 2.0 (range, 1.0-9.0), which consisted of chemotherapy, biologics, and PI3K/BCL-2 inhibitors.

Ten out of 12 evaluable patients in the MCL cohort had an objective response as their best response (83.3%). Of the patients with MCL who had an objective response, 58.3% had a complete response (CR), 25% had a partial response (PR), and 16.7% had stable disease (SD). These responses led to a clinical benefit rate of 100% in the MCL cohort. Thirty of the 34 evaluable patients with CLL or SLL achieved an objective response, which included a CR in 3% of the cohort, a PR or PR with lymphocytosis in 85%, and SD in 12%. The clinical benefit rate for the CLL/SLL cohort was also 100%. Neither cohort had any cases of progressive disease.

Lee et al noted in a swimmer plot that the majority of patients in the MCL cohort who achieved CRs did so in less than 5 months. A large majority of the complete responders in the MCL cohort also had prior ibrutinib. In a presentation of the poster, Lee stated that this signaled synergy between cirmtuzumab and ibrutinib. The CLL/SLL cohort did not show any notable signals for response.

The waterfall plots showed significant tumor regression in both cohorts.

At a median follow-up of 8.3 months, the MCL cohort showed a 17.5-month median progression-free survival (PFS), which showed favorable comparability to historical data from a pooled analysis of 3 clinical trials published in a 2019 issue of Haematologica2 that showed a PFS of 12.5 months with ibrutinib monotherapy in patients with r/r MCL and 10.3 months in patients with more than 1 prior line of therapy.

Median follow-up in the CLL cohort was 12.8 months, but the median PFS had not yet been reached.

The safety analysis showed that the combination of cirmtuzumab and ibrutinib was well tolerated in patients with MCL and CLL, with most adverse events (AEs) being grades 1 or 2 in severity. There were no dose-limiting toxicities or grade 3 events observed in the study that were found to be related to cirmtuzumab. Fatigue, diarrhea, and contusion were frequent AEs that were potentially related to cirmtuzumab alone or in combination with ibrutinib. Six subjects (8.6%) experienced any-grade neutropenia, which is known to occur in 50% to 60% of patients who received ibrutinib, according to the prescribing information.

Serious treatment-related AEs occurred in 1 patient with MCL and 9 patients with CLL, which were likely related to ibrutinib or ibrutinib plus cirmtuzumab. The serious AEs of grade 3 or higher included atrial fibrillation in 5 patients; pneumonia in 3; and pericardial hemorrhage, pleural effusion, pyrexia, hyperkalemia, gastrointestinal hemorrhage, and staph infection, which occurred in 1 patient each.

A larger proportion of patients in the MCL cohort (86.7%) experienced treatment-emergent AEs (TEAEs) of any grade than in the CLL cohort (83.6%). The same was true for grade 3 or higher TEAEs. The combination regimen was overall well tolerated.

Three patients with CLL in the study discontinued treatment due to AEs. There was also 1 patient who opted for alternative therapy and another patient who required therapy for pre-existing prostate cancer. Three patients with MCL discontinued treatment due to PD. Also, one patient with CLL was diagnosed with coronavirus disease 2019 but has a good prognosis overall.

At the time of data cutoff, the majority of the study population had completed 1 year of treatment with cirmtuzumab/ibrutinib. Sixteen individuals from the CLL cohort has also enrolled in the extended therapy while continuing treatment with cirmtuzumab plus ibrutinib.

Overall the study of cirmtuzumab in combination with ibrutinib was encouraging.

All patients in the study were 18 years of age or older with an ECOG performance status of 3 or lower, radiographically measurable disease, and in need of treatment of their disease. The study was conducted in 3 parts: dose escalation, dose expansion, and phase 2 randomization to cirmtuzumab/ibrutinib versus ibrutinib alone. Part 1 has completed enrollment, whereas parts 2 and 3 continue to accrue patients.

References:

1. Lee HJ, Choi MY, Siddiqi T, et al. Clinical activity of cirmtuzumab, an anti-ROR1 antibody, in combination with ibrutinib: Interim results of a phase Ib/II study in mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL). J Clin Oncol. 2020;38(suppl)8036. doi:10.1200/JCO.2020.38.15_suppl.8036

2. Rule S, Dreyling M, Goy A, et al. Ibrutinib for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma: Extended 3.5-year Follow Up From a Pooled Analysis. Haematologica. 2019;104(5):e211-e214. doi:10.3324/haematol.2018.205229

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Cirmtuzumab Added to Ibrutinib Induces Responses in R/R MCL and CLL - Targeted Oncology

Better Outcomes Observed With CAR T-Cell Therapy in Younger Patients With R/R DLBCL – Targeted Oncology

Chimeric antigen receptor (CAR) T-cell therapy lead to poor overall survival (OS) outcomes it patients who were 75 years or older with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) compared with patients aged 70 to 74 years, but progression-free survival was comparable between the 2 groups, according to results from a real-world analysis.

The primary objective of this study was to evaluate the efficacy and safety of CAR T cells in patients with relapsed/refractory DLBCL who are 70 years old or older. The retrospective analysis enrolled patients who were treated with either axicabtagene ciloleucel (axi-cel) or tisagenlecleucel (tisa-cel) at 5 academic medical centers in the United States. Patients were divided to 2 groups by age, including those aged 70 to 74 years old and those who were 75 years or older.

For this analysis, investigators collected baseline patient demographics, tumor characteristics, and CAR-T infusion data, then calculated the cumulative illness rating score (CIRS) and the hematopoietic cell transplantation-specific comorbidity index (HCT-CI).

The median PFS was among patients between the ages of 70 and 74 was 12 months compared with 9.4 months in those who were 75 years of age or older. The difference was P = 0.22, which was not significant. PFS was improved with the use of axi-cel in patients with transformed lymphomas (HR, 0.07; P<.001). LDH above the upper limit of normal prior to infusion was associated with a worse PFS (HR, 6.5; P<.001), and this group also was associated with a worse OS (HR, 7.4; P =.001).

The median OS was not reached in the 70 to 74 age group and was 7.8 months for the 75 year or older group, showing a difference of P = 0.049.

In the analysis, CIRS scores of 6 or greater, (OR, 3.92; P =.002), as well as axi-cel (OR, 44.9; P =.006) were associated with grade 3/4 cytokine release syndrome (CRS). Patients 75 years or older were also associated with grade 3/4 CRS (OR, 6.1; P =.003), as well as CIRS of 6 or greater (OR, 3.92; P =.04) and the use of axi-cel as treatment (OR, 44.9; P <.0001).

A worse OS was observed among those who were aged 75 years or older, but investigators did not see a difference in PFS among these patients compared to the younger group in the analysis.

Overall, higher CIRS appeared predictive of more grade 3/4 CIRS and ICANS, according to this analysis. LDH above the upper limit of normal prior to CAR T-cell infusion appeared to be associated with a worse PFS and OS in these patients.

In the younger group, the ECOG performance status was 0 in 10 patients (21.3%), 1 in 33 patients (70.2 %) or 2 or greater in 4 patients (8.5%), while the status in the older age group was 0 in 6 patients (21.4%), 1 in 18 patients (64.3%), and 2 or greater in 4 patients (14.3%). Seventeen patients (36.3%) in the younger age group had transformed from indolent lymphoma compared with 9 patients (30%) in the older age group. The cell of origin in the younger versus older age groups was GCB in 25 (53/2%) versus 15 (50.0%), ABC in 16 (34.0%) versus 11 (36.7%), and unknown in 6 (12.8%) versus 4 (13.3%), respectively.

Nine patients in the younger group (19.1%) were double- or triple-hit versus 3 patients (10%) in patients 75 years or older. The median number of prior lines was 2 (range, 2-9) in the younger group and 3 (range, 2-6) in the older group, and 11 patients (23.4%) between the ages of 70 and 74 years had received prior autologous stem cell transplant versus 2 patients (6.7%) in the older group. Fourteen patients (29.8%) had a bridging therapy in the younger group versus 15 patients (50.0%) in the older group and the median number of days between T cell collection and infusion was 28 days (range, 22-52) in the younger group versus 33 days (range, 22-63) in the older group. Forty patients (85.1%) received axi-cel and 7 patients (14.9%) received tisa-cel in the younger arm, compared with 21 patients (70.0%) and 9 (30.0%) in the older arm, respectively.

CAR T-cell therapy has revolutionized the treatment landscape for patients with relapsed/refractory DLBCL, according to the study authors. The 2 CAR T-cell agents in this real-word study were approved by the FDA based on the ZUMA-1 study (axi-cel) and the JULIET study (tis-cel). CAR T cells have now become the standard of care for patients with relapsed/refractory DLBCL.

On criticism regarding CAR T-cell therapy is that much is unknown about its efficacy and toxicity in patients who are over the age of 70. To some extent, question were answered with this real-world data.

Reference

Fitzgerald L, Kittai A, Nastoupil LJ, et al. Real-world outcomes of elderly patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with chimeric antigen receptor T-cell (CAR-T) therapy.J Clin Oncol38: 2020 (suppl; abstr 8039). doi: 10.1200/JCO.2020.38.15_suppl.8039

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Better Outcomes Observed With CAR T-Cell Therapy in Younger Patients With R/R DLBCL - Targeted Oncology

ASCO Expert Discusses the Use of Autologous Transplantation in Relapsed DLBCL – Cancer Network

In an interview with CancerNetwork, Nirav Niranjan Shah, MD, of the Medical College of Wisconsin, discussed the use of autologous stem cell transplant in patients with relapsed chemosensitive diffuse large B-cell lymphoma (DLBCL) during the era of CAR T-cell therapy.

In a data analysis using the Center of International Bone Marrow Transplant Registry (CI-BMTR), Shah and fellow investigators evaluated whether the use of autologous transplantation in this patient population should remain the standard of care.

The results of the analysis, presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting, strongly supported that autologous transplantation should remain the current standard of care.

Transcription:

Yes, I think the most important finding that I take away from this is that until we have randomized controlled trial data that shows that CAR T-cell is superior to autologous stem cell transplant in this specific patient population; that autologous transplant is the standard of care. Obviously, if you have chemo-refractory disease, well, that's a different patient population and those patients should be receiving CAR T-cell therapy. But I think we more need more data before we outright say that autologous transplant is no longer the most appropriate therapy for that particular population.

You know, the other major finding we found is that the overall survival did favor patients who had late chemotherapy failure. So that was a finding that we saw in our multivariate analysis, but besides that point, there was no difference in transplant related mortality rates of relapse or progression. And there's no difference in progression-free survival, which were the other endpoints of our analysis.

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ASCO Expert Discusses the Use of Autologous Transplantation in Relapsed DLBCL - Cancer Network

Adipose Tissue-derived Stem Cell Therapy Market 2020 | by Manufacturers | by Countries | by Types and by Applications | by Forecasts to 2026 – Farmers…

The Adipose Tissue-derived Stem Cell Therapy Market report we provide to our readers contains comprehensive data on a specific product/service, available in this industry. We want to perform in-depth analysis, to obtain a comprehensive understanding of the Adipose Tissue-derived Stem Cell Therapy Market. It starts off by going to the basics of the product/service, which is to take a look at the industry definition. The Adipose Tissue-derived Stem Cell Therapy Market report identifies and analyzes the factors which contribute and hamper the growth of this line of business. At the same time, we identify the current value of the Adipose Tissue-derived Stem Cell Therapy Market, with the estimated financial worth, at the end of the forecast period, 2020-2026.

One metric we use to understand the potential growth of the Adipose Tissue-derived Stem Cell Therapy Market is to calculate the CAGR. It helps provide accurate data, improving the quality of the data collected for this report. We make sure to analyze all the information available in this document, to ensure it meets our standards. In this report, the reader will learn which elements are responsible for creating demand for the product/service under observation. At the same time, the reader will also get to know about product/service types that boost the popularity of this industry.

The key players covered in this study > AlloCure, Antria, Celgene Corporation, Cellleris, Corestem, Cytori Therapeutics, Intrexon, Mesoblast, Pluristem Therapeutics, Tissue Genesis, BioRestorative Therapies, Celltex Therapeutics Corporation, iXCells Biotechnologies, Pluristem Therapeutics, Cyagen, Lonza.

The final report will add the analysis of the Impact of Covid-19 in this report Adipose Tissue-derived Stem Cell Therapy industry.

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Market Segmentation

For the purpose of making the information available on Adipose Tissue-derived Stem Cell Therapy Market comprehensive, we segmented the industry. The reason is that it helps our readers learn in-depth about this line of business. The segmentation of the Adipose Tissue-derived Stem Cell Therapy Market is as follows distribution channel, product type, region, and application. When it comes to application, it deals with end-users, who are responsible for generating demand for the product/service. Product type refers to the different variants available in the Adipose Tissue-derived Stem Cell Therapy Market. We use distribution channel, to understand the various sources companies use to supply the product/service to the consumers.

Regional Overview

In the regional overview portion, the Adipose Tissue-derived Stem Cell Therapy Market report has data from countries all over the world. Each region is responsible for contributing to the growth of this industry. From the available data, we will identify which area has the largest share of the market. At the same time, we will compare this data to other regions, to understand the demand in other countries. North and South America, Asia Pacific, Middle East and Africa, and Europe are the areas of interest in this Adipose Tissue-derived Stem Cell Therapy Market report.

Table Of Content

1 Report Overview

2 Global Growth Trends

3 Market Share by Key Players

4 Breakdown Data by Type and Application

5 North America

6 Europe

7 China

8 Japan

9 Southeast Asia

10 India

11 Central & South America

12 International Players Profiles

13 Market Forecast 2020-2026

14 Analysts Viewpoints/Conclusions

15 Appendix

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Latest Industry News

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Adipose Tissue-derived Stem Cell Therapy Market 2020 | by Manufacturers | by Countries | by Types and by Applications | by Forecasts to 2026 - Farmers...

Trending 2020 Lysosomal Storage Disease Treatment Market Segmentation, Analysis by Recent Trends, Development & Growth by Regions – Cole of Duty

Lysosomal Storage Disease TreatmentMarket 2020: Inclusive Insight

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Lysosomal Storage Disease Treatment Market competition by top manufacturers/ Key player Profiled: Takeda, Pfizer, Sanofi, BioMarin, Merck, Actelion Pharmaceuticals, Eli Lilly,

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Global Lysosomal Storage Disease Treatment Market is estimated to reach xxx million USD in 2020 and projected to grow at the CAGR of xx% during 2020-2026. According to the latest report added to the online repository of Alexareports the Lysosomal Storage Disease Treatment market has witnessed an unprecedented growth till 2020. The extrapolated future growth is expected to continue at higher rates by 2026.

Lysosomal Storage Disease Treatment Market Segment by Type covers: Enzyme Replacement Therapy, Stem Cell Transplantation, Substrate Reduction Therapy

Lysosomal Storage Disease Treatment Market Segment by Application covers:Hospitals, Clinics, Stem Transplant Centers, Research Organizations

After reading the Lysosomal Storage Disease Treatment market report, readers get insight into:

*Major drivers and restraining factors, opportunities and challenges, and the competitive landscape*New, promising avenues in key regions*New revenue streams for all players in emerging markets*Focus and changing role of various regulatory agencies in bolstering new opportunities in various regions*Demand and uptake patterns in key industries of the Lysosomal Storage Disease Treatment market*New research and development projects in new technologies in key regional markets*Changing revenue share and size of key product segments during the forecast period*Technologies and business models with disruptive potential

Based on region, the globalLysosomal Storage Disease Treatment market has been segmented into Americas (North America ((the U.S. and Canada),) and Latin Americas), Europe (Western Europe (Germany, France, Italy, Spain, UK and Rest of Europe) and Eastern Europe), Asia Pacific (Japan, India, China, Australia & South Korea, and Rest of Asia Pacific), and Middle East & Africa (Saudi Arabia, UAE, Kuwait, Qatar, South Africa, and Rest of Middle East & Africa).

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What will the market growth rate of Lysosomal Storage Disease Treatment market?What are the key factors driving the global Lysosomal Storage Disease Treatment market size?Who are the key manufacturers in Lysosomal Storage Disease Treatment market space?What are the market opportunities, market risk and market overview of the Lysosomal Storage Disease Treatment market?What are sales, revenue, and price analysis of top manufacturers of Lysosomal Storage Disease Treatment market?Who are the distributors, traders, and dealers of Lysosomal Storage Disease Treatment market?What are the Lysosomal Storage Disease Treatment market opportunities and threats faced by the vendors in the global Lysosomal Storage Disease Treatment industries?What are sales, revenue, and price analysis by types and applications of Lysosomal Storage Disease Treatment market?What are sales, revenue, and price analysis by regions of Lysosomal Storage Disease Treatment industries?

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Table of ContentsSection 1 Lysosomal Storage Disease Treatment Product DefinitionSection 2 Global Lysosomal Storage Disease Treatment Market Manufacturer Share and Market Overview2.1 Global Manufacturer Lysosomal Storage Disease Treatment Shipments2.2 Global Manufacturer Lysosomal Storage Disease Treatment Business Revenue2.3 Global Lysosomal Storage Disease Treatment Market Overview2.4 COVID-19 Impact on Lysosomal Storage Disease Treatment IndustrySection 3 Manufacturer Lysosomal Storage Disease Treatment Business Introduction3.1 Takeda Lysosomal Storage Disease Treatment Business Introduction3.1.1 Takeda Lysosomal Storage Disease Treatment Shipments, Price, Revenue and Gross profit 2014-20193.1.2 Takeda Lysosomal Storage Disease Treatment Business Distribution by Region3.1.3 Takeda Interview Record3.1.4 Takeda Lysosomal Storage Disease Treatment Business Profile3.1.5 Takeda Lysosomal Storage Disease Treatment Product Specification3.2 Pfizer Lysosomal Storage Disease Treatment Business Introduction3.2.1 Pfizer Lysosomal Storage Disease Treatment Shipments, Price, Revenue and Gross profit 2014-20193.2.2 Pfizer Lysosomal Storage Disease Treatment Business Distribution by Region3.2.3 Interview Record3.2.4 Pfizer Lysosomal Storage Disease Treatment Business Overview3.2.5 Pfizer Lysosomal Storage Disease Treatment Product Specification3.3 Sanofi Lysosomal Storage Disease Treatment Business Introduction3.3.1 Sanofi Lysosomal Storage Disease Treatment Shipments, Price, Revenue and Gross profit 2014-20193.3.2 Sanofi Lysosomal Storage Disease Treatment Business Distribution by Region3.3.3 Interview Record3.3.4 Sanofi Lysosomal Storage Disease Treatment Business Overview3.3.5 Sanofi Lysosomal Storage Disease Treatment Product Specification3.4 BioMarin Lysosomal Storage Disease Treatment Business Introduction3.5 Merck Lysosomal Storage Disease Treatment Business Introduction3.6 Actelion Pharmaceuticals Lysosomal Storage Disease Treatment Business IntroductionSection 4 Global Lysosomal Storage Disease Treatment Market Segmentation (Region Level)4.1 North America Country4.1.1 United States Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.1.2 Canada Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.2 South America Country4.2.1 South America Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.3 Asia Country4.3.1 China Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.3.2 Japan Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.3.3 India Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.3.4 Korea Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.4 Europe Country4.4.1 Germany Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.4.2 UK Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.4.3 France Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.4.4 Italy Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.4.5 Europe Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.5 Other Country and Region4.5.1 Middle East Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.5.2 Africa Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.5.3 GCC Lysosomal Storage Disease Treatment Market Size and Price Analysis 2014-20194.6 Global Lysosomal Storage Disease Treatment Market Segmentation (Region Level) Analysis 2014-20194.7 Global Lysosomal Storage Disease Treatment Market Segmentation (Region Level) AnalysisSection 5 Global Lysosomal Storage Disease Treatment Market Segmentation (Product Type Level)5.1 Global Lysosomal Storage Disease Treatment Market Segmentation (Product Type Level) Market Size 2014-20195.2 Different Lysosomal Storage Disease Treatment Product Type Price 2014-20195.3 Global Lysosomal Storage Disease Treatment Market Segmentation (Product Type Level) AnalysisSection 6 Global Lysosomal Storage Disease Treatment Market Segmentation (Industry Level)6.1 Global Lysosomal Storage Disease Treatment Market Segmentation (Industry Level) Market Size 2014-20196.2 Different Industry Price 2014-20196.3 Global Lysosomal Storage Disease Treatment Market Segmentation (Industry Level) AnalysisSection 7 Global Lysosomal Storage Disease Treatment Market Segmentation (Channel Level)7.1 Global Lysosomal Storage Disease Treatment Market Segmentation (Channel Level) Sales Volume and Share 2014-20197.2 Global Lysosomal Storage Disease Treatment Market Segmentation (Channel Level) AnalysisSection 8 Lysosomal Storage Disease Treatment Market Forecast 2019-20248.1 Lysosomal Storage Disease Treatment Segmentation Market Forecast (Region Level)8.2 Lysosomal Storage Disease Treatment Segmentation Market Forecast (Product Type Level)8.3 Lysosomal Storage Disease Treatment Segmentation Market Forecast (Industry Level)8.4 Lysosomal Storage Disease Treatment Segmentation Market Forecast (Channel Level)Section 9 Lysosomal Storage Disease Treatment Segmentation Product Type9.1 Enzyme Replacement Therapy Product Introduction9.2 Stem Cell Transplantation Product Introduction9.3 Substrate Reduction Therapy Product IntroductionSection 10 Lysosomal Storage Disease Treatment Segmentation Industry10.1 Hospitals Clients10.2 Clinics Clients10.3 Stem Transplant Centers Clients10.4 Research Organizations ClientsSection 11 Lysosomal Storage Disease Treatment Cost of Production Analysis11.1 Raw Material Cost Analysis11.2 Technology Cost Analysis11.3 Labor Cost Analysis11.4 Cost OverviewSection 12 Conclusion

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Trending 2020 Lysosomal Storage Disease Treatment Market Segmentation, Analysis by Recent Trends, Development & Growth by Regions - Cole of Duty