Category Archives: FDA Stem Cell Trials

Last year Peyton Manning flew to Europe on a private jet, not for tea and crumpets or to see the Louvre, but for an experimental stem-cell treatment on his injured neck. The procedure, one that isn't even legal in the United States, allegedly took his own fat cells and used them to try to regrow damaged neck tissue: "There are many proposed therapies that are being tested in clinical trials, and there are more to come," Dr. Lawrence Goldstein, director of the stem cell program at the University of California, San Diego, told ABC News. "But in the absence of reliable evidence, it is impossible to know whether the 'treatment' will make Manning better or worse or merely financially poorer." TheNFL doesn't have any rules specifically banning illegal procedures that an athlete can have done in foreign locales. Kobe Bryant, the NBA's aging lion, had similarly cutting-edge treatment on his arthritic knee in Germany. It's called "Biologic Medicine,"and in addition to Bryant, super-agent Ari Emanueland the late Pope John Paul II were ardent believers. There are a ton of controversial treatments possible where science collides with loose regulation. Bone marrow injections filled with those miracle-working stem cells can be injected … Continue reading →

GAITHERSBURG, MD--(Marketwire -06/08/12)- Cytomedix, Inc. (CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that four poster presentations highlighting the clinical merits of the Company's AutoloGel System in wound management will be presented at the 44th Annual Conference of the Wound Ostomy and Continence Nurses Society ("WOCN") being held in Charlotte, North Carolina from June 9-13, 2012. The AutoloGel System, a device for the production of autologous platelet rich plasma ("PRP") gel, is the only PRP device cleared by the U.S. Food and Drug Administration ("FDA") for use in wound management. The following posters highlighting Cytomedix's PRP technology will be presented at WOCN 2012: "This body of clinical data demonstrates AutoloGel's ability to accelerate wound healing in common wound etiologies and also shows its effectiveness on fistulas, pseudostomas, and pressure ulcers in persons with spinal cord injury, which are all notoriously difficult to heal wounds. In addition, the data shows that AutoloGel saves money while increasing healing rates and decreasing staff time," commented Carelyn P. Fylling, RN, MSN, CWS, CLNC, Cytomedix's Vice President of Professional Services. "We are pleased to have these four posters presented … Continue reading →

This article is written by a member of our expert contributor community. Ive been directing or advising innovation and commercialization efforts in Silicon Valley for most of my career. While the popular stories we tell about innovation usually focus on eureka moments and brilliant individuals, anyone involved in successful innovation knows that getting a new product to market is often more about convincing smart people to back your idea, corralling lots of different agendas, aligning incentives, and navigating bureaucracies. I was reminded of this very important difference between invention and impactful innovation when I attended the One Mind for Research conference at UCLA recently.One Mind for Researchis a new nonprofit that serves as a catalyst for discovering and delivering breakthrough cures for brain disease, co-founded by Garen Steglin, a successful VC and CEO, and Patrick Kennedy, former Congressmen and nephew of JFK, and now led by Pete Chiarelli, U.S. Army General (retired).This was a gathering of top university neuroscientists, celebrities like Glenn Close and Maria Shiver, foundations, industry senior executives, government officials, patients, and advocates. A Burden on Patients, Employers, and The Economy This is an area desperately in need of innovation. Brain diseases and trauma are a leading cause … Continue reading →

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced promising clinical data in five poster presentations for ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use, as well as a poster presentation and one e-abstract publication for belinostat, at the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Illinois, from June 1-5, 2012. ZEVALIN Promising clinical findings in DLBCL, including in elderly patients; ZEVALIN further associated with reduced need for chemotherapy A Phase 2 investigator-sponsored study in patients with stage III/IV CD20+ DLBCL (Abstract # 6633) found that short-duration therapy consisting of rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone given every 14 days (RCHOP-14) followed by ZEVALIN resulted in a 3-year overall survival (OS) of 100%. Three-year progression-free survival (PFS) was 90% in this patient cohort. The Phase 2 study was an international, open-label, non-randomized trial in a total of 30 CD20+ DLBCL patients aged between 65 and 80, 25 of whom completed treatment. An additional investigator-sponsored Phase 2 study (Abstract #8056) demonstrated that short-duration therapy of ZEVALIN with rituximab showed complete response rate durations comparable to full-course R-CHOP in … Continue reading →

CHICAGO--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today announced that data from several clinical trials of ADCETRIS (brentuximab vedotin) will be presented at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting being held June 1-5, 2012 in Chicago, IL. Data demonstrate the activity and tolerability when patients are retreated with ADCETRIS, the activity and tolerability of ADCETRIS in CD30-positive non-Hodgkin lymphomas and CD30 expression from a screening protocol in non-lymphoma malignancies. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. Our goal is for ADCETRIS to become the foundation of therapy for CD30-positive malignancies and, to that end, we are aggressively investing in its clinical development and broadly exploring CD30 expression across numerous cancer types, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. Our data presentations at ASCO highlight the potential for ADCETRIS and reinforce our development strategy to generate data that will support stepwise growth of ADCETRIS for patients with CD30-expressing malignancies. Retreatment with brentuximab vedotin in CD30-positive hematologic malignancies: a phase II study (Abstract #8027) In a phase II trial, patients who previously responded to treatment with ADCETRIS, then discontinued treatment and subsequently had disease progression or relapse were eligible for retreatment. … Continue reading →

Stem cells provided by San Diego-based Stemedica Cell Technologies Inc. are expected to be used soon in a phase I/II clinical trial for chronic heart failure in Mexico. Stemedica announced May 29 that its strategic Mexico partner, Grupo Angeles Health Services, has received approval for a single-blind randomized clinical trial from Mexicos FDA equivalent regulatory agency, COFEPRIS. The trial being conducted at multiple hospital sites throughout Mexico will involve Stemedicas adult allogeneic ischemia tolerant mesenchymal stem cells delivered via intravenous infusion. The trial will involve three safety cohorts at different dosages, followed by a larger group being treated with the maximum safe dosage. The trial, set to begin on or before July 1 with 60 to 80 patients, is one of only two studies using allogeneic stem cells approved by COFEPRIS. The other study approved in 2010 was a clinical trial for ischemic stroke. We are pleased that we will be working with the largest and most prestigious private medical institution in Mexico to study Stemedicas product for this indication, said Stemedica CEO Maynard Howe in a statement. If successful, our stem cells may provide a treatment option for the millions of patients, both in Mexico and internationally, who suffer … Continue reading →

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced key presentations of clinical data, including five ZEVALIN-related poster presentations, as well as a poster presentation and one e-abstract publication of clinical data for belinostat, at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, Illinois, from June 1-5, 2012. For more information about the ASCO annual meeting and for a complete list of abstracts, please refer to the conference Web site at http://abstract.asco.org/. The following are key ZEVALIN-related abstracts being presented at the ASCO conference: Monday June 4, 2012, 1:15 PM - 5:15 PM Central Time First Author S Hall A2 S Hall A2 S Hall A2 S Hall A2 See the original post here: Spectrum Pharmaceuticals Highlights Seven Abstracts of Clinical Data at the 2012 American Society of Clinical Oncology ... … Continue reading →

Toni Clarke BOSTON Globe and Mail Update Published Friday, May. 18, 2012 12:38PM EDT Last updated Friday, May. 18, 2012 12:56PM EDT Osiris Therapeutics Inc. OSIR-Q said on Thursday that Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world. Osiris shares rose 14 per cent to $6.00 in extended trading after the news was announced. Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient's body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting. The disease kills up to 80 per cent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids. Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company's chief executive, said in an interview that could take three to four years. Some investment analysts … Continue reading →

SAN DIEGO, May 29, 2012 /PRNewswire/ --Marshall Edwards, Inc. (MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that the first cohort of patients has been dosed in a Phase I clinical trial of ME-344, the Company's lead mitochondrial inhibitor drug candidate, in patients with refractory solid tumors. The dose escalation trial is expected to enroll up to 24 patients in up to five cohorts with final safety and pharmacokinetic data expected in the first half of 2013. "We are very pleased to see the excitement surrounding our initial clinical trial of ME-344, with the first cohort of patients now well underway just a month after our Investigational New Drug application was approved by the FDA," said Robert D. Mass, MD, Chief Medical Officer of Marshall Edwards. "ME-344 is a novel compound that showed compelling anti-tumor activity in pre-clinical studies. Now we look forward to gathering valuable clinical data in the months ahead, all of which will help to optimize the design of our Phase II efficacy studies." The Phase I clinical trial is evaluating the safety and tolerability of intravenous ME-344 in escalating dose cohorts of 1.2 mg/kg, 2.5 mg/kg, 5 … Continue reading →

Stem cells have assumed near-mythical status in the popular imagination as a possible cure for every disease under the sun. But while public attention has focused on their potential in regenerative medicine, stem cells have quietly gained a foothold in drug development a move that may hail a huge but unheralded shake-up of the biological sciences. I think there are tremendous parallels to the early days of recombinant DNA in this field, says James Thomson, director of regenerative biology at the Morgridge Institute for Research in Madison, Wisconsin, and one of the founders of Cellular Dynamics International, also in Madison. I dont think people appreciated what a broad-ranging tool recombinant DNA was in the middle '70s." At the same time, he says, they underestimated the difficulty of using it in treatments. Now stem cells are in a similar situation, he says, and although therapeutic use is likely to come to fruition eventually, people underappreciate how broadly enabling a research tool it is, he says. Laboratory-grown stem cells hold much promise for regenerative medicine, but are being increasingly used in drug testing. MASSIMO BREGA, THE LIGHTHOUSE/SCIENCE PHOTO LIBRARY Drug companies began dipping a tentative toe into the stem-cell waters about two … Continue reading →