2020-2025 Global and Regional Stem Cell Therapy for Osteoarthritis Industry Production, Sales and Consumption Status and Prospects Professional Market…

The global Stem Cell Therapy for Osteoarthritis market report by HNY Research offers users a detailed overview of the market and all the main factors affecting the market. The study on global Stem Cell Therapy for Osteoarthritis market, offers profound understandings about the Stem Cell Therapy for Osteoarthritis market covering all the essential aspects like revenue growth, supply chain, sales, key players and regions. There is a target set in market that every marketing strategy has to reach. This report on Stem Cell Therapy for Osteoarthritis focusses on different categories that define this market with a systematic approach that addresses the consumer base, researchers and market experts like the stakeholders. It also gives a clear perspective towards the competition and demand and supply chain.

Request a sample of this report @ https://www.orbisresearch.com/contacts/request-sample/4361431

Manufacturer Detail

By Market Players:Mesoblast, Regeneus, U.S. Stem Cell, Anterogen, Asterias Biotherapeutics

By Application

By TypeMonotherapy, Combination Therapy

The Stem Cell Therapy for Osteoarthritis market report also offers some presentations and illustrations about the market that comprises pie charts, graphs, and charts which presents the percentage of the various strategies implemented by the service providers in the global Stem Cell Therapy for Osteoarthritis market. This report on Stem Cell Therapy for Osteoarthritis has been very well drafted to benefit anyone studying it. There are different marketing strategies that every marketer looks up to in order to ace the competition in the Global market. Some of the primary marketing strategies that is needed for every business to be successful are Passion, Focus, Watching the Data, Communicating the value To Your Customers, Your Understanding of Your Target Market. Every market research report follows a robust methodology to define its market value. By doing so, the Stem Cell Therapy for Osteoarthritis research study by HNY Research offers collection of information and analysis for each facet of the Stem Cell Therapy for Osteoarthritis market such as technology, regional markets, applications, and types.

Browse the complete report @ https://www.orbisresearch.com/reports/index/2020-2025-global-and-regional-stem-cell-therapy-for-osteoarthritis-industry-production-sales-and-consumption-status-and-prospects-professional-market-research-report

This study can benefit investors and business owners in many ways. It studies the business models, strategies, growth, innovations and every information about manufacturers that can help make business predictions and fetch good results. Making right business decisions is an undeniable measure that needs to be taken for market growth. Every market has a set of manufacturers, vendors and consumers that define that market and their every move and achievements becomes a subject of studying for market researchers and other stakeholders. One of the most important aspects focused in this study is the regional analysis. Region segmentation of markets helps in detailed analysis of the market in terms of business opportunities, revenue generation potential and future predictions of the market. For Stem Cell Therapy for Osteoarthritis report, the important regions highlighted are North America, South America, Asia, Europe and Middle East. Another important aspect of every market research report by HNY Research is the study of the key players or manufacturers driving the market forward. The process helps to analyze the opponent thoroughly.

Make an enquiry of this report @ https://www.orbisresearch.com/contacts/enquiry-before-buying/4361431

About Us:

Orbis Research (orbisresearch.com) is a single point aid for all your market research requirements. We have vast database of reports from the leading publishers and authors across the globe. We specialize in delivering customized reports as per the requirements of our clients. We have complete information about our publishers and hence are sure about the accuracy of the industries and verticals of their specialization. This helps our clients to map their needs and we produce the perfect required market research study for our clients.

Contact Us:Hector CostelloSenior Manager Client Engagements4144N Central Expressway,Suite 600, Dallas,Texas 75204, U.S.A.Phone No.: USA: +1 (972)-362-8199 | IND: +91 895 659 5155Email ID: [emailprotected]

Read the rest here:
2020-2025 Global and Regional Stem Cell Therapy for Osteoarthritis Industry Production, Sales and Consumption Status and Prospects Professional Market...

Young priest receives news of fatal disease, offers up suffering in reparation for sin – Lifesite

March 3, 2020 (LifeSiteNews) A U.S. Catholic priest is counting his blessings including the support of the communities he has shepherded the last five years following his recent diagnosis with a progressive neurodegenerative disease.

The way of the cross that Jesus is inviting me to walk will not be easy, but He and His holy Mother Mary will uphold me. I continue to do my best to surrender myself to Jesus knowing that He will take care of everything, the Rev. Dana Christensen posted on his personal Facebook page Dec. 21.

Christensen, 42, had been diagnosed with amyotrophic lateral sclerosis, also known as ALS or Lou Gehrigs Disease, earlier that week.

ALS, or amyotrophic lateral sclerosis, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord, according to the ALS Association website. The progressive degeneration of the motor neurons in ALS eventually leads to their demise. When the motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle action progressively affected, people may lose the ability to speak, eat, move and breathe.

While there is no cure for ALS, he is taking medications that may slow its progress, and he is engaged in clinical trials at the Mayo Clinic in Rochester, Minn.

I am personally at peace with this, although I have my moments, he wrote Dec. 21. I am convinced that this is a mysterious gift from God through the hands of Our Lady of Fatima to bring me to salvation and entrust me with the mission to live my priesthood in a new way.

Christensen, who has been otherwise healthy all his life, began to notice that things were not right in July. It started with muscle twitching and changes to his voice. Initially, he saw his primary care physician, who sent him to a neurologist, where a series of tests were conducted, with an attempt to rule out ALS and other serious diseases.

I really didnt realize how serious it was until I got the phone call the end of October telling me the working diagnosis was ALS, he said. Then things got real serious, real fast.

Christensen called the timing of that phone call providential, as he received it as he journeyed home from a pilgrimage to Fatima, Portugal, where Catholics believe that Mary appeared to three children, predicting the future of the world and calling upon Christians to pray the rosary daily and make sacrifices on behalf of sinners.

I see in (the timing of the call) the protection of Our Blessed Mother Mary, Christensen said.

But his acceptance of the diagnosis has not been without struggle.

After the first diagnosis, I went through what I call a period of freaking out, including a deep depression, panic attacks and fear, the priest shared. However, with time and lots of prayer, I have come to have peace about it. I know, beyond a shadow of a doubt, that God has allowed this for my own growth in holiness and is an opportunity to help others grow as well. I believe God will and is using this for good. I trust in Him.

In some ways, Christensen said the diagnosis has made him a better priest.

I thought I knew what to say and do for (those who have received bad news about their health), but once I was the one receiving that news, I realized how naive I had been. Until we get the bad news ourselves, we have no idea what it is like, he said.

Christensen said that his health has revealed a call from God to practice what I preach.

I often preach about being confident in Gods Mercy and trusting His plan for our lives, he said. Now I have to put it into practice.

On Jan. 10, the Catholic Feast of the Baptism of the Lord, Christensen told his congregation of a puzzling inscription over a doorway in Greece that says, If you die before you die, when you die, you will not die.

The priest explained that, in baptism, Christians are buried in water and rise up to live their lives differently.

With his voice wavering from the effects of his ALS, Christensen told parishioners, If, all of our life, we take up our cross and die daily to ourselves, if we choose Gods will instead of our own, if we accept all of the daily deaths that come to us, whether it be grief, whether it be illness, whether it be any number of daily dyings that come to us, if we live those as Jesus did, if we allow Him to die in us, then we have nothing to fear. For, when our death comes, we will have already died, and all that will be left for us is to live eternally.

Following delivery of that sermon, Christensen shared that a priest always preaches to himself first and foremost, and that it was a good summation of how I see this. It helps me to not fear death, because of having already died with Christ, what is there to fear?

Christensen continues to pastor the Catholic parishes in Alexandria, Emery and Bridgewaterbetween appointments with a variety of doctors at the Mayo Clinic in Rochester, Minn., where he will undergo experimental treatment for ALS.

In his initial Facebook post, Christensen asked followers to to pray for a miraculous healing through the intercession of Venerable Fulton J. Sheen using the following prayer:

Eternal Father, You alone grant us every blessing in Heaven and on earth, through the redemptive mission of Your Divine Son, Jesus Christ, and by the working of the Holy Spirit. If it be according to Your Will, glorify Your servant, Archbishop Fulton J. Sheen, by granting the favor I now request through his prayerful intercession (in a miraculous healing for Fr. Christensen). I make this prayer confidently through Jesus Christ, Our Lord. Amen.

I believe in miracles, and as (God) did for the leper who cried out to Him, Lord, if thou wilt, thou canst make me clean, (Luke 5:12), He can also heal me, Christensen continued.

Sheen was one of the greatest preachers in modern Catholicism in these United States, and was really the first to use television to preach the Gospel, Christensen explained recently.One of the ways the Church uses to decide if a person is worthy of sainthood is for unexplained miracles to happen through their intercession in heaven. So, often when a miracle is desired, we turn to those being considered for sainthood, asking them to pray for us in heaven.Since we know from Sacred Scripture that God is a God of the living, and that all in heaven are alive in Christ, and that the saints in heaven intercede for us on earth, we ask them to pray for us just as we ask those living on earth to pray for us.

Acknowledging that, typically, ALS is a death sentence, Christensen continued in his initial post that he has surrendered to what will become of him.

As in all things, not my will, but His be done, he wrote. I accept whatever He has in store for me, and I offer it to Jesus through the hands of Mary, in reparation for my own sins and the sins of the whole world, and for the salvation of sinners.

Recently, Christensen shared that he had given Jesus and his mother, Mary, permission to do whatever it takes to makeme a saint.

I believe that this is a mysterious answer to this prayer, he said. I believe that Jesus is allowing me to be united to Him in His suffering, so that I may be united with Him in His glory.

Admitting he is a proud man, Christensen also suggested that his ALS is an attempt by God to humble him, to become little and in need of help to teach me that He is everything. It is only in becoming weak that we are made strong in Jesus, he said.

Christensen attributed his outward strength and optimism in the wake of his daunting diagnosis to God and his grace working through others.

It is astounding to me that people fromliterally around the world are praying for me, he said.

Though his strength and grace in the face of medical uncertainty have been noted by parishioners and others in the area, Christensen also asked that the faithful pray for his continued surrender to what will be, as well as for the comfort of his family, who have been instrumental in his care thus far.

By our prayers you will accompany me on my own way of the cross, he said.

To help with whatever care Christensen may need, local parishioners are spearheading additional practical aid. A fund has been created to offset the expenses of experimental treatment that isnt covered by insurance at Security State Bank in Alexandria. Those wishing to contribute to the fund can make deposits to the Padre Christensen Fund at the bank.

The funds, according to a press release, will cover experimental drugs or ethical stem cell treatments, travel to and from appointments, lodging, skilled in-home nursing and other future expenses related to Christensens care. Those with questions regarding fundraising efforts are invited to contact Camille Davies (605-933-0574 or [emailprotected]) or Don Wenande (605-770-0595 or [emailprotected]). In addition to the bank fund, Padres Fight t-shirts and sweatshirts are for sale.

Editors note: This article first appeared in The Alexandria Herald and The Emery Enterprise. It is republished here by permission of the author.

The rest is here:
Young priest receives news of fatal disease, offers up suffering in reparation for sin - Lifesite

CytoDyn Reports Remarkable Outcomes for Additional Cancer Patients in mTNBC Trial; Following an Overwhelming Community Response, CytoDyn Expects to…

VANCOUVER, Washington, March 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today continued positive data for its mTNBC and MBC patients.

Metastatic triple-negative breast cancer (mTNBC), an aggressive histological subtype, has a poor prognosis. In addition, metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options. An integral part of CytoDyns mission and purpose is to provide effective therapeutic solutions to these patients. Results of the first five patients are as follows:

Patient #1: Enrolled in mTNBC Phase 1b/2 - Injected on 9/27/2019. CTC (circulating tumor cells) dropped to zero in two weeks on 10/11/2019. Total CTC and EMT (Epithelial Mesenchymal Transition in Tumor Metastasis) dropped to zero after about one month of treatment with leronlimab (once-a-week 350 mg dose). Results from the patients earlier CT scan indicated a more than 25% tumor shrinkage within the first few weeks of treatment with leronlimab. Most importantly, after more than five months of treatment with leronlimab and Carboplatin, the patient not only has zero CTC and zero EMT, but also zero detectible CAML (cancer-associated microphages like cells).

Patient #2: Enrolled in single IND. Patient is MBC with HER2+ stage 4 metastasis to lung, liver, and brain. Patients radiologist cancelled 2nd round of treatment due to leronlimabs effect on shrinking the largest tumor in the brain by 56% and other lesions being stable. Leronlimab has and continues to be the only treatment in place for brain metastasis after radiation was administered to this patient in July 2019. Four and one-half months after successful radiation treatment, the patient received her first dose of leronlimab (700 mg) and no other drugs to treat the brain metastasis. The 56% shrinkage in the brain lesions occurred after only two once-weekly injections of leronlimab. After 10 weeks of treatment with leronlimab, this patients CTC and EMT results were all zeros (results reported on 2/12/2020). The patients CT scan in mid-February was reported as stable.

Patient #3: Enrolled on 1/3/2020. This patients CAML counts decreased from 45 to 30. CTC+EMT are stable and there has been no change in the total number. Despite positive results, this patient stopped treatment due to complications with her implanted port, which was unrelated to leronlimab.

Patient #4: Enrolled on 1/7/2020. This patients total CTC dropped by 75% in the first two weeks of treatment with leronlimab. After almost five weeks of treatment, the CTC remained at zero.

Patient #5: Enrolled on 2/4/2020. This patient has traveled from England to receive leronlimab. Initial response from treatment indicated tumor shrinkage and, importantly, CTC dropped to zero after three weeks of leronlimab treatment.

Patients #6 and #7: Enrolled and waiting for the first results post-baseline results.

Patients #8 through #10: Will be injected in early March.

Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, Patients continue to be actively enrolled in this trial based on the expression of CCR5 on lymphocytes and macrophages in the tumor microenvironment. The proposed mechanism of action (MOA) consisting of inhibition of Tregs and repolarization of macrophages has demonstrated a predictable, sustained response that has reduced the size of primary and metastatic tumors and reduced circulating tumor cells in all patients tested so far.

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, added, These findings are solidifying our belief of the four mechanism of actions (MOA) for leronlimab in the treatment of cancer, as previously verified through preclinical animal studies and in published papers. These MOAs indicate that leronlimab may potentially stop metastasis in many types of solid tumor cancers, trigger the bodys immune response system to destroy the cancer tumor and perhaps more. This could represent the beginning of the transformation of CytoDyn from a potential leader in HIV therapy to providing potentially a new innovative treatment opportunity to patients with various forms of cancer and potentially NASH, GvHD, MS, and perhaps many more indications. With the possibility of our first approval in HIV late this year, we could have over 30 label expansion opportunities post-HIV approval.

About Triple-Negative Breast CancerTriple-negative breast cancer (TNBC) is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer growthestrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene. TNBC cancer occurs in about 10 to 20 percent of diagnosed breast cancers and can be more aggressive and more likely to spread and recur. Since the triple-negative tumor cells lack these receptors, common treatments for breast cancer such as hormone therapy and drugs that target estrogen, progesterone, and HER-2 are ineffective.

About Leronlimab (PRO 140)The U.S. Food and Drug Administration (FDA) have granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including NASH. Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is therefore conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additionalclinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTS

Investors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

Continue reading here:
CytoDyn Reports Remarkable Outcomes for Additional Cancer Patients in mTNBC Trial; Following an Overwhelming Community Response, CytoDyn Expects to...

Ozzy Osbourne banking on stem cell treatment to get him back onstage – Music News

Ozzy Osbourne is banking on a stem cell treatment and Pilates to help him manage his Parkinson's disease.

The Paranoid hitmaker has been laid up since badly injuring himself and suffering from pneumonia last year, revealing he had a type of Parkinson's in January, and scrapping his U.S. tour last month, to head to Switzerland for treatment.

In a joint interview with U.K. TV show Good Morning Britain, Ozzy and his wife and manager Sharon opened up about the rocker's recovery - revealing he is undergoing stem cell treatment to lessen the effects of Parkinson's and to boost his immune system.

"There's a professor there (in Switzerland)," Sharon said. "He hasn't got a cure for Parkinson's, no one has but what he can do is... he can get Ozzy's imune system to here (points high), so now, if Ozzy was to catch a cold it would turn into pneumonia.

"This professor has come up with a way of doing stem cells where it helps with the pain. He could hopefully get rid of Ozzy's pain and then Ozzy will be healthier to deal with the Parkinson's."

The 71-year-old is not the first person in his family to undergo stem cell treatment, as his son Jack flew to Germany to receive similar therapy to help with his multiple sclerosis.

Meanwhile, the former Black Sabbath frontman has also been working hard to get fit again - but thinks he will only truly feel himself again when he's back performing.

"I exercise as much as I can. I've got a trainer, I do Pilates, nurses 24/7, but the best medication I can get is being in front of an audience, which is breaking my heart, to be honest," he added. "I will (perform again). Absolutely. I will be up there. I have to say that. I know you're going to say what will you do if you can't do it again, that's not an option because I will do it."

Continued here:
Ozzy Osbourne banking on stem cell treatment to get him back onstage - Music News

“American Journal of Sports Medicine” publishes results of an FDA-approved clinical trial for treating osteoarthritis knee pain – P&T Community

LOUISVILLE, Colo. andNEW ORLEANS andSAN ANTONIO andCHICAGO, March 2, 2020 /PRNewswire/ -- GID BIOannounced today that The American Journal of Sports Medicinepublished resultsof its FDA-approved multi-site, randomized, placebo-controlled Phase IIb clinical trial measuring the safety and efficacy of its SVF-2 device and point-of-care (POC) therapy intended to treat pain and function associated with knee osteoarthritis.

The Phase IIb clinical study was approved by the FDA under an IDE and is the first regenerative cell therapy for osteoarthritis to meet study endpoints using autologous stromal cells from adipose tissue. The cellular therapy for osteoarthritis procedure showed no serious adverse events at two years and a significant reduction in pain at one year. A Phase III pivotal study begins soon at Tulane University School of Medicinewith additional trial sites participating nationwide.

"Publishing this data signifies real science and a breakthrough in regenerative medicine. We've completed a prior safety trial, an FDA-approved Phase IIb trial, and are now beginning a Phase III pivotal trial. Physicians will be able to use the SVF-2 technology to provide a cellular therapy option for patients," said principal investigator for the Phase III trial, Jaime R. Garza, MD, DDS, FACS, Professor of Orthopedic Surgery and Center for Stem Cell Research and Regenerative Medicineat Tulane University School of Medicine. "I am very proud to collaborate with my alma mater, Tulane University, and the School of Medicine's outstanding orthopedic department led by Dr. Felix Savoie, and its worldclass Center for Stem Cell Research and Regenerative Medicine directed by expert cell scientist Dr. Bruce Bunnell," said Dr. Garza.

Dr. Garza is a former NFL player and a Tulane University Athletic Hall of Fame inductee. He is also a clinical professor of plastic surgery and otolaryngology at the University of Texas Health Science Center.

Treatments by clinics using stem cells are under scrutiny by the FDA as its discretionary enforcement period expires in November of this year. The intent is that hundreds of stem cell clinicsnationwide become compliant with FDA regulations, leading to clinical data support of safety and efficacy.

"Our randomized, controlled clinical trial is the first cellular therapy study for osteoarthritis to meet study endpoints using autologous adipose stromal cells for a point-of-care therapy.Eighty-eight percent of subjects responded greater than placebo at one year and reported a median 87% improvement in pain, stiffness and function," said William W. Cimino, Ph.D., CEO of GID BIO. "We are able to isolate and concentrate the right types and numbers of cells to create an effective therapy. We are pleased to begin Phase III trials with Dr. Garza, and to be at the forefront for a cellular therapy option for osteoarthritic knees."

About GID SVF-2 and POC TherapyGID technology has reduced a Good Manufacturing Practice (GMP) cell-processing facility to a single-use disposable device for scalable point-of-care cell processing. The technology uniquely harvests and isolates stromal cells from a patient's own adipose tissue that is then reimplanted by injection in a physician's office in less than two hours. Stromal cells play an essential role in the body's natural healing response, with a dynamic and reactive ability to participate in the healing process. The American Medical Associationgranted GID two new CPT class III codesthat became effective January 2020 as a step toward Medicare reimbursement.

About GID BIOGID BIO develops next-generation cellular therapies for degenerative musculoskeletal, dermal, and organ-specific diseases, with the goal of making cellular medicine available to as many people as possible. GID's SVF-2 device and POC therapy harnesses the innate healing power of a patient's own stromal cells. Information on GID's SVF-2 device, biologic cellular implants, POC therapy, osteoarthritis clinical program and GID's pipeline for treating degenerative disease in musculoskeletal conditions includes other indications including, dermal and organs, specifically, wound care and diabetes. Learn more: https://www.HealingIntelligently.com.

AboutTulane University School of MedicineOne of the nation's most recognized centers for medical education,Tulane University School of Medicineis a vibrant center for education, research and public service.Tulane School of Medicineis the second-oldest medical school in the Deep South and the 15th oldest medical school inthe United States.Tulane School of Medicinerecruits top faculty, researchers and students from around the world, and pushes the boundaries of medicine with groundbreaking medical research and surgical advances.Tulaneremains in the forefront of modern medical innovation and is equipping the next generation of medical professionals with the tools to succeed in the rapidly changing future of health care.

About American Journal of Sports MedicineAglobal organization with 3,000 members that generates evidence-based knowledge and promotes emerging research to educate orthopaedic surgeonsand a resource for the orthopaedic sports medicine community, American Journal of Sports Medicine is a peer-reviewed scientific journal, first published in 1972. It is the official publication ofAOSSMfeaturing 14 issues per year. The journal acts as an important forum for independent orthopaedic sports medicine research and education, allowing clinical practitioners the ability to make decisions based on sound scientific information.

Contact:Kellee Johnson, 312-751-3959 or kjohnson@ballastgroup.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/american-journal-of-sports-medicine-publishes-results-of-an-fda-approved-clinical-trial-for-treating-osteoarthritis-knee-pain-301014538.html

SOURCE GID BIO

See the original post here:
"American Journal of Sports Medicine" publishes results of an FDA-approved clinical trial for treating osteoarthritis knee pain - P&T Community

Fate Therapeutics Reports Fourth Quarter 2019 Financial Results and Operational Progress with 2020 Outlook – Yahoo Finance

Reported Initial Clinical Data from FT500 Phase 1 Study in Advanced Solid Tumors, Supporting Safety and Tolerability of Multi-dose Treatment Paradigm for Off-the-shelf, iPSC-derived NK Cells

First Patients Treated with FT516, the First-ever Engineered iPSC-derived Cellular Immunotherapy, for AML and for B-cell Lymphoma in Combination with Rituximab

Initiated Enrollment of First-in-human Clinical Trial of FT596, the First-ever Cellular Immunotherapy Engineered with Three Active Anti-tumor Modalities

Ended Quarter with $261 Million in Cash, Cash Equivalents and Marketable Securities

SAN DIEGO, March 02, 2020 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today reported business highlights and financial results for the fourth quarter ended December 31, 2019.

In 2019, we made tremendous progress in pioneering the clinical development of off-the-shelf, iPSC-derived cancer immunotherapy. Our FT500 program demonstrated that multiple doses of iPSC-derived NK cells can be delivered off-the-shelf to a patient in a safe manner without patient matching. Additionally, our FT516 program provided initial clinical evidence that engineered iPSC-derived NK cells may confer anti-tumor activity and deliver clinically meaningful benefit to patients. We also showed the unmatched scalability of our proprietary iPSC product platform, having manufactured hundreds of cryopreserved, infusion-ready doses of our iPSC-derived NK cell product candidates at a low cost per dose in our new GMP manufacturing facility, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. In 2020, we look forward to additional clinical data from our FT500 and FT516 programs, and initial clinical data from FT596, our ground-breaking iPSC-derived CAR NK cell product candidate for the treatment of B-cell malignancies designed to overcome many of the limitations inherent in current CAR T-cell immunotherapies. We also expect to begin clinical investigation of our off-the-shelf, iPSC-derived NK cell programs in multiple myeloma with planned IND submissions for FT538, the first-ever CRISPR-edited, iPSC-derived cell therapy, and for FT576, our multi-antigen targeted, CAR-BCMA product candidate. Finally, under our collaboration with Memorial Sloan Kettering, we strive to be the first group in the world to bring off-the-shelf, iPSC-derived CAR T-cell therapy to patients.

Clinical Programs

Preclinical Pipeline

Fourth Quarter 2019 Financial Results

Today's Conference Call and Webcast

The Company will conduct a conference call today, Monday, March 2, 2020 at 5:00 p.m. ET to review financial and operating results for the quarter ended December 31, 2019. In order to participate in the conference call, please dial 877-303-6229 (domestic) or 631-291-4833 (international) and refer to conference ID 9879730. The live webcast can be accessed under "Events & Presentations" in the Investors & Media section of the Company's website at http://www.fatetherapeutics.com. The archived webcast will be available on the Company's website beginning approximately two hours after the event.

About Fate Therapeutics iPSC Product PlatformThe Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

Story continues

About FT500

FT500 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line. The product candidate is being investigated in an open-label, multi-dose Phase 1 clinical trial for the treatment of advanced solid tumors (NCT03841110). The study is designed to assess the safety and tolerability of three once-weekly doses of FT500 as a monotherapy and in combination with one of three FDA-approved immune checkpoint inhibitor (ICI) therapies nivolumab, pembrolizumab or atezolizumab in patients that have failed prior ICI therapy. Despite the clinical benefit conferred by approved ICI therapy against a variety of tumor types, these therapies are not curative and, in most cases, patients either fail to respond or their disease progresses on these agents. One common mechanism of resistance to ICI therapy is associated with loss-of-function mutations in genes critical for antigen presentation. A potential strategy to overcome resistance is through the administration of allogeneic NK cells, which have the inherent capability to recognize and directly kill tumor cells with these mutations.

About FT516

FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in an open-label, multi-dose Phase 1 clinical trial as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-directed monoclonal antibodies for the treatment of advanced B-cell lymphoma (NCT04023071). Additionally, the FDA has allowed investigation of FT516 in an open-label, multi-dose Phase 1 clinical trial in combination with monoclonal antibody therapy, including PDL1-, PD1-, EGFR- and HER2-targeting therapeutic antibodies, across a broad range of solid tumors.

About FT596FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology, which contains a NKG2D transmembrane domain, a 2B4 co-stimulatory domain and a CD3-zeta signaling domain, that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that promotes enhanced NK cell activity. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and hnCD16 targeting receptors, in combination with IL-15RF signaling, convey synergistic anti-tumor activity. Increased degranulation and cytokine release were observed upon dual receptor activation in lymphoma cancer cells as compared to activation of each receptor alone, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a humanized mouse model of lymphoma, FT596 in combination with the anti-CD20 monoclonal antibody rituximab showed enhanced killing of tumor cells in vivo as compared to rituximab alone. FT596 is being investigated in an open-label Phase 1 clinical trial as a monotherapy, and in combination with rituximab, for the treatment of advanced B-cell lymphoma and in combination with obinutuzumab for the treatment of chronic lymphocytic leukemia (NCT04245722).

About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Companys immuno-regulatory product candidates include ProTmune, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

Forward-Looking Statements

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Companys results of operations, financial condition and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and plans related to its product candidates, clinical studies and preclinical research and development programs, the Companys progress, plans and timelines for the manufacture and clinical investigation of its product candidates, the timing for the Companys receipt of data from its clinical trials and preclinical studies, the Companys development and regulatory strategy, and the therapeutic and market potential of the Companys product candidates. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results observed in prior studies of the Companys product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Companys product candidates or in the initiation of, or enrollment of patients in, any clinical studies, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, difficulties or delays in patient enrollment in current and planned clinical trials, difficulties in manufacturing or supplying the Companys product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that the Companys expenditures may exceed current expectations for a variety of reasons. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Availability of Other Information about Fate Therapeutics, Inc.

Investors and others should note that the Company routinely communicates with investors and the public using its website (www.fatetherapeutics.com) and its investor relations website (ir.fatetherapeutics.com) including, without limitation, through the posting of investor presentations, SEC filings, press releases, public conference calls and webcasts on these websites. The information posted on these websites could be deemed to be material information. As a result, investors, the media, and others interested in Fate Therapeutics are encouraged to review this information on a regular basis. The contents of the Companys website, or any other website that may be accessed from the Companys website, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited)

Condensed Consolidated Balance Sheets(in thousands)(unaudited)

Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200christina@sternir.com

See the article here:
Fate Therapeutics Reports Fourth Quarter 2019 Financial Results and Operational Progress with 2020 Outlook - Yahoo Finance

Fate Therapeutics: 4Q Earnings Snapshot – Thehour.com

Published 4:10pm EST, Monday, March 2, 2020

SAN DIEGO (AP) _ Fate Therapeutics Inc. (FATE) on Monday reported a loss of $28.3 million in its fourth quarter.

The San Diego-based company said it had a loss of 37 cents per share.

The results surpassed Wall Street expectations. The average estimate of eight analysts surveyed by Zacks Investment Research was for a loss of 39 cents per share.

The clinical-stage biotech company that develops stem cell treatments posted revenue of $2.8 million in the period, also exceeding Street forecasts. Seven analysts surveyed by Zacks expected $1.8 million.

For the year, the company reported that its loss widened to $98.1 million, or $1.44 per share. Revenue was reported as $10.7 million.

Fate Therapeutics shares have climbed 58% since the beginning of the year. In the final minutes of trading on Monday, shares hit $30.95, a rise of 87% in the last 12 months.

_____

This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on FATE at https://www.zacks.com/ap/FATE

Link:
Fate Therapeutics: 4Q Earnings Snapshot - Thehour.com