Category Archives: FDA Stem Cell Trials

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced safety findings from the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase (HDAC) inhibitor. As featured in an oral presentation at the T-Cell Lymphoma Forum held in San Francisco, January 24-26, the BELIEF trial safety evaluation showed belinostat had an acceptable safety profile in patients with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL), including patients who have received a previous allogeneic or autologous stem cell transplant. The BELIEF trial is evaluating the efficacy and safety of intravenous belinostat for the treatment of patients with R/R PTCL. As announced in December 2012, the BELIEF trial surpassed an objective response rate (ORR) of at least 20% in these patients, the studys primary efficacy endpoint as established under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). We are pleased that the T-Cell Lymphoma Forum, one of the preeminent conferences for innovation in the treatment of blood cancers, highlighted the BELIEF study comprehensive safety profile, stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, … Continue reading →

THOUSAND OAKS, Calif., Jan. 26, 2013 /PRNewswire/ -- Amgen (AMGN) announced today results from Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES), a Phase 3 trial which evaluated Neulasta (pegfilgrastim) in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for the first-line treatment of locally-advanced or metastatic colorectal cancer. FOLFOX and FOLFIRI are two of the most commonly used chemotherapy regimens for colorectal cancer. The study met its primary endpoint, with Neulasta significantly reducing the incidence of febrile neutropenia. Febrile neutropenia is a low white blood cell count accompanied by a fever.1 In the study, the incidence of grade 3 or 4 febrile neutropenia in patients receiving Neulasta across the first four cycles of chemotherapy was 2.4 percent compared to 5.7 percent in the placebo group (OR=0.41, p=0.014). A similar incidence of grade 3 or higher adverse events was seen in both arms of the trial (28 percent placebo; 27 percent Neulasta). "This analysis showed that PAVES met its primary endpoint, with Neulasta significantly reducing the incidence of febrile neutropenia in patients with colorectal cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen."In addition to providing new data on Neulasta, we believe PAVES will provide valuable … Continue reading →

SAN DIEGO, Jan. 25, 2013 /PRNewswire/ -- Scripps Clinic, in partnership with The Scripps Research Institute (TSRI), has begun the research phase of a proposed clinical trial using induced pluripotent stem cells to halt or reverse the effects of Parkinson's disease. (Logo: http://photos.prnewswire.com/prnh/20121018/LA95241LOGO) Under the leadership of Melissa Houser, MD, neurologist and medical director of Scripps Clinic's Parkinson's Disease and Movement Disorders Center, and co-investigator Jeanne F. Loring, PhD, professor and director of the Center for Regenerative Medicine at TSRI, skin cells taken from Parkinson's disease patients who meet select criteria are being cultivated in vitro and turned into pluripotent stem cells. These stem cells will be developed into dopamine-producing brain cells. The plans, which will require Food and Drug Administration (FDA) approval, are to implant these cells back into the donor patients' brains; the goal is for the cells to integrate inside the brain and produce enough dopamine to alleviate the worst symptoms of Parkinson's disease. There are currently several clinical trials using pluripotent stem cells to replace cells lost to injury or neurodegenerative disease, as well as for the development of pharmaceuticals, but reimplantation of cells into the same patient for function restoration as a treatment for Parkinson's … Continue reading →

BOTHELL, Wash. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced the initiation of a global phase III clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed CD30-positive mature T-cell lymphoma (MTCL) patients, including patients with systemic anaplastic large cell lymphoma (sALCL) and other types of peripheral T-cell lymphomas. The trial, also known as ECHELON-2, is being conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) and also received scientific advice from the European Medicines Agency (EMA). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for use in the front-line treatment of MTCL. The standard of care for newly diagnosed MTCL, a chemotherapy regimen called CHOP, has not changed in more than three decades, and there is a significant need to identify enhanced treatment options for these patients, said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. Recent phase I data from 26 patients presented at the ASH annual meeting showed that adding ADCETRIS to CHP resulted in compelling … Continue reading →

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)-- BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that its CEO, Dr. Adrian Harel, has issued an Annual Letter to Shareholders summarizing the companys extremely significant developments of 2012: Dear BrainStorm Shareholders, 2012 has been a pivotal year for BrainStorm, as the company has achieved the most significant milestones since its inception. Weve made dramatic progress in our clinical trials, establishing the safety of NurOwn cells in a first group of ALS patients and demonstrating promising indications of clinical improvement in some patients. As a result weve been fast-tracked to a Phase IIa preliminary efficacy trial after only one year of testing. Weve also made key advances in product development, and secured the largest amount of financing in any single year of operations. I am proud to share with you the major highlights of the past twelve months: I. Clinical Trials Progress In early June, we performed the 12th ALS patient transplantation in our Phase I/II clinical trial with NurOwn at Hadassah Medical Center in Jerusalem. In July, we submitted a positive interim safety report to the Israeli Ministry of Health (MOH) on the … Continue reading →

(Repeats story first published on Jan. 19) By Julie Steenhuysen CHICAGO, Jan 19 (Reuters) - Fighting the flu may soon get easier. As early as next year, more modern and more effective vaccines will hit the market, thanks to investments by the U.S. government and pharmaceutical companies. And even bigger scientific advances are expected in the next decade, including a "universal" flu vaccine given every five to 10 years that would fight many strains of a virus, making annual shots all but obsolete. Experts say it could take eight to 10 more years of testing before a universal flu vaccine would be ready. Meanwhile, they expect advances that could still incrementally improve the level of protection vaccines offer and shorten manufacturing times. In the last 12 months, the U.S. Food and Drug Administration has approved two new seasonal flu vaccines that protect against four predominant strains of flu instead of three. One is a shot made by GlaxoSmithKline (Other OTC: GLAXF - news) and the other is a nasal spray made by AstraZeneca (NYSE: AZN - news) . In late November (Xetra: A0Z24E - news) , the FDA approved Novartis (Berlin: NOT.BE - news) ' new flu vaccine grown in … Continue reading →

Government investment gives flu vaccines a shot in the arm January 22, 2013 (Reuters) Fighting the flu may soon get easier. As early as next year, more modern and more effective vaccines will hit the market, thanks to investments by the U.S. government and pharmaceutical companies. And even bigger scientific advances are expected in the next decade, including a "universal" flu vaccine given every five to 10 years that would fight many strains of a virus, making annual shots all but obsolete. Experts say it could take eight to 10 more years of testing before a universal flu vaccine would be ready. Meanwhile, they expect advances that could still incrementally improve the level of protection vaccines offer and shorten manufacturing times. In the last 12 months, the U.S. Food and Drug Administration has approved two new seasonal flu vaccines that protect against four predominant strains of flu instead of three. One is a shot made by GlaxoSmithKline and the other is a nasal spray made by AstraZeneca. In late November, the FDA approved Novartis' new flu vaccine grown in cultures of dog kidney cells instead of the conventional chicken eggs, a faster and more reliable manufacturing process that could help … Continue reading →

As we discussed in our first article on elite regenerative medicine companies, there are several methodologies to delineating the cream of the crop. In this exercise, we will take a look at the impact that regenerative medicine technologies can have on ischemic conditions where tissue in the heart, brain, organs or limbs are damaged as a result of restricted blood flow and identify some of the most innovative companies that have a strong upside based on the products and technologies they are developing, stage of development, and current valuations. Ischemic conditions are expansive, covering common conditions such as stroke, heart disease and peripheral vascular disease (which in severe cases can result in critical limb ischemia, requiring amputation of digits or limbs). The economic impact of these types of conditions is also substantial. Research by the American Heart Association indicates that cardiovascular disease (most of which is ischemic in nature) comprises more than $300 billion in healthcare related expenses annually, accounting for more than 17% of total healthcare related expenses in the U.S. Furthermore, these conditions impose a huge quality of life burden for patients and their families, and therefore are areas of great unmet medical need. From a company and … Continue reading →

CHICAGO (Reuters) - Fighting the flu may soon get easier. As early as next year, more modern and more effective vaccines will hit the market, thanks to investments by the U.S. government and pharmaceutical companies. And even bigger scientific advances are expected in the next decade, including a "universal" flu vaccine given every five to 10 years that would fight many strains of a virus, making annual shots all but obsolete. Experts say it could take eight to 10 more years of testing before a universal flu vaccine would be ready. Meanwhile, they expect advances that could still incrementally improve the level of protection vaccines offer and shorten manufacturing times. In the last 12 months, the U.S. Food and Drug Administration has approved two new seasonal flu vaccines that protect against four predominant strains of flu instead of three. One is a shot made by GlaxoSmithKline and the other is a nasal spray made by AstraZeneca. In late November, the FDA approved Novartis' new flu vaccine grown in cultures of dog kidney cells instead of the conventional chicken eggs, a faster and more reliable manufacturing process that could help build stockpiles in the event of a pandemic. And this past … Continue reading →

GAITHERSBURG, MD--(Marketwire - Jan 14, 2013) - Cytomedix, Inc. ( OTCQX : CMXI ) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that it has received the 2012 North American Frost & Sullivan New Product Innovation Award for its Angel concentrated platelet-rich plasma (cPRP) system. This is an award that is presented each year by Frost & Sullivan to a company that has developed an innovative element in a product by leveraging leading-edge technologies. The award recognizes the value-added features and benefits of the product and the increased return on investment it offers to customers. Martin P. Rosendale, chief executive officer of Cytomedix, commented, "We are delighted to receive this award from Frost & Sullivan which recognizes the advanced technological features and commercial potential of our Angel system.Angel is positioned as a 'best in class' PRP device that represents a significant engineering advance in the separation of whole blood and bone marrow for clinical use and offers clear competitive advantages over other currently available systems." "A unique feature of Angel is its flexible therapeutic output, which allows physicians to generate customized platelet concentrates at the point-of-care," said Aarti Shetty, research … Continue reading →