Category Archives: FDA Stem Cell Trials

SAN DIEGO, CA--(Marketwire -04/25/12)- Medistem Inc. (MEDS.PK - News) announced Dr. Gene Ray, founder of $2.6 Billion Titan Corp, has invested in and joined the Advisory Board for Medistem Inc. Dr. Ray is a Ph.D in Theoretical Physics, Inventor, and Entrepreneur who founded and sold Titan Corp for $2.6 Billion. Dr. Ray has a long track record of success in developing science and technology solutions for the Department of Defense and Homeland Security. "When Dr. Ichim presented Medistem's story to me two years ago, I was intrigued by the possibility of security and military applications of the Universal Donor adult stem cell that Medistem has discovered," said Dr. Ray. "Since that time, Medistem has obtained FDA approval for clinical trials, numerous publications in peer-reviewed journals with top-notch Universities, and built an experienced management team. When Medistem asked for my help in assisting with strategic issues associated with value optimization and positioning in the arena of military/radioprotectant applications, I was eager to not only offer my expertise, but also to become an investor in the company." A native of Kentucky, Dr. Ray's academic achievements include: B.S. in Mathematics, Physics & Chemistry, Murray State University, M.S. in Physics and Ph.D in Theoretical … Continue reading →

SACRAMENTO, Calif., April 18, 2012 /PRNewswire/ -- SynGen Inc. ("SynGen" or the "Company"), a Regenerative Medicine device company focused on the development of next generation stem cell harvesting systems, announced today that it has completed a $5 million Series A preferred stock financing with Bay City Capital, LLC (BCC). Under the terms of the transaction, BCC will appoint two representatives to SynGen's board of directors. "We are delighted to have the opportunity to work with Bay City Capital to maximize SynGen's potential. Their expansive knowledge of the global life science field and vast networking capability combined with a strong reputation as a top tier venture capital firm made our decision easy," said Phil Coelho, SynGen's president and CEO. "During the due diligence process, BCC had already begun facilitating business relationships important for our accelerated growth and market expansion." Mr. Coelho continued, "We will use these proceeds to accelerate the commercialization of our SynGen-1000 platform product (http://syngeninc.com/ProductPipeLine.htm). Initially, we intend to make the SynGen-1000 available to cord blood banks. These banks value the substantially improved cell recovery and high purity of stem and progenitor cells that the product provides, in addition to its ease-of-use, reduced costs and improved data recording standards … Continue reading →

STAINES, UK, March 31, 2012 /PRNewswire/ -- Clostridium difficile infection (CDI), a potentially fatal disease, is one of the most common healthcare acquired infections inEurope[1] New data presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) demonstrate that in cancer patients with CDI, DIFICLIR(fidaxomicin) may offer significant benefits in terms of clinical cure*, recurrence[#] and sustained clinical cure[=].[2] The data presented were derived from two Phase III clinical trials. A post hoc analysis compared outcomes in patients who had a diagnosis of cancer with outcomes for patients who did not. In the clinical trials, the data on cancer diagnosis was not collected as a pre-defined endpoint. CDI is the leading cause of healthcare-acquired diarrhoea in adults[1] and has become an increasing problem in hospitals, nursing homes and other long-term care facilities.[3] A person's risk of CDI increases with a longer period of hospitalisation.[4] Patients who have received chemotherapy and those with solid tumours can be particularly susceptible to CDI due to their long hospital stays and exposure to many antibiotics and chemotherapeutic agents.[5] "Patients with cancer represent a vulnerable population who are at high risk of CDI, often resulting from their compromised immune system. CDI can … Continue reading →

SAN DIEGO, March 30, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR - News) announced the presentation of results from a post-hoc subgroup analysis of the company's two large Phase 3 trials which demonstrated that cancer patients with Clostridium difficile-associated diarrhea (CDAD) had higher clinical cure rates, better sustained response and lower recurrence when treated with DIFICID (fidaxomicin) tablets compared to oral vancomycin. The data will be presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in London. (Logo: http://photos.prnewswire.com/prnh/20090413/LA97352LOGO) The analysis included 153 patients with active cancer who were treated in the two DIFICID Phase 3 studies and who received 8 days or more of treatment with DIFICID or oral vancomycin. In the overall combined population, patients with cancer had significantly lower cure and sustained response rates than patients without cancer. DIFICID was five times more likely than vancomycin to produce a clinical response and three times more likely to lead to a sustained response, while patients treated with vancomycin had a 2.6 fold greater risk of experiencing recurrence. Specifically, DIFICID provided superior response compared to vancomycin across all clinical endpoints studied: clinical response (97.3% vs. 87.5%, 95% CI 1.07-23.98; p=0.041), sustained response (83.6% vs. … Continue reading →

SAN DIEGO, March 30, 2012 /PRNewswire/ --Cardium Therapeutics (NYSE Amex: CXM) today announced market introduction of its Excellagen professional-use, syringe-based wound care product for the management of diabetic foot ulcers, pressure ulcers and other dermal wounds. (Photo: http://photos.prnewswire.com/prnh/20120330/LA79308) (Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO) Excellagen is a new, FDA-cleared highly-refined fibrillar collagen-based topical gel (2.6%) designed to support favorable wound care management. Excellagen's unique high molecular weight bovine Type I collagen formulation is topically applied through easy-to-control, pre-filled, single use syringes. Excellagen is intended for physician use following surgical debridement procedures, and is engineered to support a favorable wound healing environment for non-healing lower extremity ulcers in diabetic patients. Excellagen's viscosity optimized biocompatible gel formulation requires application at only one or two week intervals. It is recommended that Excellagen be applied following surgical debridement in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors. Cardium's market research indicates that physicians seek easy-to-use products to reduce preparation time and facilitate product application - and Excellagen's unique, ready-to-use syringe-based collagen gel requires no thawing or mixing. Because of its specialized formulation, only a thin layer needs to be applied over the wound area, and one syringe containing 0.5 … Continue reading →

As the basketball frenzy that accompanies March Madness draws to the fever pitch of the Final Four, it brings to mind that basketball is a high contact sport. A quick peek at the NBA injured list reveals a catalog of breaks and tears that affect tendons, ligaments and bones. The pressure to improve performance and search for quick recoveries has led some celebrity athletes to seek out stem cell treatments overseas and in the U.S. Among NBA players to get stem cell treatments are Jason Kidd, Tracy McGrady, Amar Stoudemire, Allan Houston and Kenyon Martin, according to a Sports Illustrated article. Advertisement Dragoo said in a phone interview that the publicity has actually had a negative impact on the development of clinically proven stem cell therapies for orthopedic medicine and how it is perceived. Because of this market pressure, private clinics have been offering stem cells treatments both here in the USA as well as around the world. Often, these treatments have not been studied and are not regulated in any way. FDA [U.S. Food and Drug Administration] regulations have also severely limited new clinical trials in stem cell therapy in the USA. The ethical debate of using embryonic stem … Continue reading →

Defibrotide usage increased by 28% to EUR 16.89 million (US$ 21.91 million) Total product sales of EUR 21.73 million (US$ 28.19 million) Net income of EUR 2.71 million (US$ 3.52 million) Cash flow positive and stronger cash position VILLA GUARDIA (COMO), Italy, March 27, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT - News) (the "Company") today reported financial results for the quarter and year ended December 31, 2011. The Company reports its financial and operating results using U.S. Generally Accepted Accounting Principles (GAAP). The Company's financial statements are prepared using the Euro as its functional currency. On December 31, 2011, EUR 1.00 = $1.2973. "We are pleased to report that Defibrotide usage increased by 28% in 2011 when compared with 2010, and total product sales fell within our most recent range of guidance of EURO21-23 million ($27.2 -$29.8 million). We have been able to finance the establishment of our European commercial team, repay the current portion of our long-term debt and fund our working capital," stated Salvatore Calabrese, SVP Finance and Chief Financial Officer of Gentium S.p.A. "We ended 2011 with a net income of EURO2.71 million ($3.52 million), which was impacted by a tax reform that established a minimum … Continue reading →

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN - News) today announced that the Journal of Clinical Oncology (JCO) published results of the companys pivotal clinical trial of ADCETRIS (brentuximab vedotin) in Hodgkin lymphoma (HL) patients with relapsed or refractory disease following an autologous stem cell transplant (ASCT). The findings, published today online, demonstrated that treatment with ADCETRIS as a single agent induced durable objective responses in 75 percent of patients and was associated with a manageable safety profile. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in HL and anaplastic large cell lymphoma (ALCL). Additionally, a separate pivotal clinical trial of ADCETRIS for the treatment of relapsed or refractory systemic ALCL has been accepted for publication and is currently in press for an upcoming issue of JCO. Although Hodgkin lymphoma is often viewed as a curable disease, up to 30 percent of patients relapse or are refractory following front-line chemotherapy regimens and subsequent treatments, leaving limited therapeutic options, said Dr. Anas Younes, Professor of Medicine and Director, Clinical Investigation and Translational Research Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. ADCETRIS represents a new approach that is changing the way we treat … Continue reading →

Like us on Facebook George Zavocio: I have a Ph.D. in physiology and I've worked for a number of pharmaceutical and biotechnology companies, including Bristol-Myers Squibb Co. (BMY:NYSE), Alexion Pharmaceuticals Inc. (ALXN:NASDAQ) and T Cell Sciences, which is now Celldex Therapeutics Inc. (CLDX:NASDAQ). In addition to physiology, my interest and experience lies in pathology and biochemistry and particularly in signal transduction pathways-how messages signal from the outside to the inside of the cell. That segues into diseases that depend on signaling transduction for their pathogenesis, and they include cancer, autoimmune disease and inflammation. I follow companies that discover and develop drugs for these indications and for treating cardiovascular diseases. I'm also interested in molecular diagnostics. Medicine is moving beyond just diagnosis and prognosis to predicting how individual patients will respond to drugs and how their disease will progress. That, in a nutshell, is my theme. TLSR: Is there a key focus? GZ: Oncology is one of my key focuses. There are more oncology companies out there than practically any other type of disease-focused company, so it's easy to pick oncology companies-or at least to screen them to find some that I like. The autoimmune/inflammation space is less well populated by … Continue reading →

GOLDEN, Colo., March 20, 2012 (GLOBE NEWSWIRE) -- Vitro Diagnostics, Inc. (OTCQB:VODG.PK - News), dba Vitro Biopharma, has recently received approval for its presentation entitled "GMP Cell Culture Media for Expansion of MSCS Prior to Allogeneic or Autologous Transplantation." The Company recently expanded its stem cell media products to include clinical grade MSC-Gro(TM) media for use in clinical trials of stem cells. The Company will present its current findings at the annual meeting of the International Society of Cellular Therapy (ISCT) in Seattle, Washington this coming June. To get more information regarding the International Society of Cellular Therapy visit http://www.celltherapysociety.org/ Vitro Biopharma has developed a series of products to support clinical application of adult stem cells known as mesenchymal stem cells (MSCs) that are completely divorced and different from ethically contentious embryonic stem cells. MSCs are derived from numerous adult tissue sources including bone marrow, blood, adipose tissue, teeth, etc and show considerable promise in clinical applications especially for treatment of injury and diseases affecting joints, bone, ligaments and tendons. There are over 200 ongoing clinical trials of MSCs to study potential treatment of diabetes, Parkinson's disease, organ transplant rejection, osteoarthritis, MS, spinal cord injury, stroke, myocardial infarction, cardiovascular disease, … Continue reading →