Category Archives: FDA Stem Cell Trials

Stem cell company Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) today announced it is about to begin Phase II clinical trials in the US to evaluate the safety and efficacy of its PLacental Expanded (PLX) cells in the treatment of Intermittent Claudication (IC), a type of peripheral artery disease (PAD). The US Food and Drug Administration (FDA) granted clearance to start the Phase II clinical trial in April, and Pluristem, which develops placenta-based cell therapies, will commence the trials in the first week of September. Pluristem has already received Institutional Review Board (IRB) approval for the trial protocol for five out of the eleven US clinical site locations via its relationship with Western IRB, which has approved Pluristem's protocol. Site initiation will begin on September 5th at Duke University Medical Center with other sites becoming active in the following weeks following. Pluristem also plans to initiate trials in Europe and Israel in parallel to the eleven US sites. The study's lead principal investigator at Duke Dr. Manesh Patel said, "We are pleased to participate in the clinical trial process of this novel technology. Duke University Medical Center participated as a clinical site in Pluristem's Phase I/II trial using PLX-PAD cells … Continue reading →

IRVINE, CA--(Marketwire -08/22/12)- Grants totaling more than $1.6 million were awarded by the Cystinosis Research Foundation for 11 new research projects seeking to cure cystinosis and advance new treatments for the rare metabolic and fatal disease. The newly funded studies include research focused on corneal cystinosis, muscle wasting and stem cells. Cystinosis afflicts about 500 children and young adults in the United States and about 2,000 worldwide. The new CRF research will be under way at universities and hospitals in the United States, France, Belgium, Switzerland and New Zealand. Since 2003, the CRF has raised more than $19 million and funded 105 multi-year research studies and fellowships in 11 countries. The CRF is the largest fund provider of cystinosis research. CRF-funded research led to discovery of a dramatic improvement in the life-saving medication and to the first allogeneic stem cell clinical pilot study for cystinosis which is being conducted at the Ronald Reagan UCLA Medical Center. Recently, two CRF-funded researchers were awarded NIH grants totaling more than $3 million, leveraging CRF grant money. "CRF is guided by a Scientific Review Board, a world renowned group of cystinosis experts and scientists who evaluate every research application we receive. Their expertise and … Continue reading →

By Mike Volkin - August 18, 2012 | Tickers: AVEO, DNDN, IMGN, SGEN, VRTX | 0 Comments Mike is a member of The Motley Fool Blog Network -- entries represent the personal opinions of our bloggers and are not formally edited. By George S. Mack, The Life Sciences Report For more interviews with sector experts and analysts, please sign up for our newsletter at http://www.thelifesciencesreport.com. Imagine a novel discovery or even a novel platform that just fizzles. To a technology freak like me that sounds so disappointing to think that you can actually discover breakthrough ideas that are not disruptive and don't really change much. I recently spoke to Ray Blanco who was so inquisitive as a kid in the 1960s that he built a Wilson cloud chamber in his parents' basement to detect vapor trails revealing movement of subatomic particles. He's still at it, but now it's about building financial models to assess the value and prospects of innovative companies. Today, as an editor and contributor to several investment publications at Agora Financial, Blanco is satisfying his still-healthy curiosity by finding small-, mid-, and even a few large-cap tech stocks with potential to usher in new paradigms and make … Continue reading →

NEW YORK, Aug. 16, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: http://www.reportlinker.com/p0955290/Personalized-Medicine---A-Global-Market-Overview.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic `Personalized Medicine can mean a lot of things to a lot of people. For some, it may relate to doctors having knowledge about their case history and the treatment received, which is a morale boosting factor, since everybody wants caregivers who can comprehend an individual's problems. The day is not very far when this level of personal or individual understanding between a patient and a doctor would be much deeper than hitherto anticipated. The coming decade is expected to witness an increase in the use of companion diagnostics and personalized medicines, with pricing incentives and efficiency improvement propelling the market. Current market leaders with diagnostic divisions focusing on biomarker identification would be at an advantage. This report review, analyze and projects the personalized medicine market for global and the regional markets including the United States, Europe and Rest of World. The market numbers illustrated in this report only represent the market exclusively for the product segments and technologies enunciated above. The market, in this report, does not include the associated hardware equipment or software technologies that are used to … Continue reading →

MOUNTAINSIDE, N.J.--(BUSINESS WIRE)-- Proteonomix, Inc. (OTC/BB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, today announced that the U.S. Food and Drug Administration (FDA) has granted permission to the Company to initiate a Phase 1 clinical trial with its mobilization technology UMK-121. The Proteonomix-sponsored trial will evaluate UMK-121 in patients with end-stage liver disease (ESLD). Permission by the FDA marks an important milestone in our plans to initiate a Company-sponsored clinical trial with UMK-121, following years of research and investment to advance development of this drug candidate, said Proteonomix Chief Technology Officer Steven Byle. We hope and anticipate that this trial will demonstrate the potential of UMK-121 to mobilize stem cells in order to improve liver function in patients with ESLD. We consider ourselves fortunate to be involved with a development-stage therapy that could improve the life expectancy for this class of terminally ill patients awaiting liver transplants. Proteonomix CEO Michael Cohen added, This is a significant step for our Company as this is the first FDA IND to be held by Proteonomix and demonstrates the ability of the Company to move basic research projects into clinical trials. UMK-121 is … Continue reading →

NEW YORK, Aug. 14, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company") today announced second quarter results and provided a business update. NeoStem is rapidly emerging as a market leader in the fast growing cell therapy market. The Company's multifaceted business strategy combines a state-of-the-art contract development and manufacturing organization (CDMO) with a medically important cell therapy product development program providing for near- and long-term revenue growth opportunities. Business Highlights Progress Report on Erye Divestiture As of today, NeoStem has received directly or into escrow $6.2 million representing 50% of the total $12.3 million cash purchase price. The divestiture of Erye will also return approximately 1,040,000 shares of the Company's Common Stock and cancel 1,170,000 Common Stock options and 640,000 Common Stock warrants. In addition to receiving $12.3 million in cash to use towards U.S. operations, the divestiture will bolster NeoStem's balance sheet by eliminating over $35 million in short- and long-term debt obligations. The divestiture transaction is expected to close in the next 6-10 weeks, subject to the satisfaction of various closing conditions including China regulatory approvals, the submission of which is already underway. The Company's second quarter results include Erye, its Pharmaceutical Manufacturing -- … Continue reading →

GAITHERSBURG, MD--(Marketwire -08/09/12)- Cytomedix, Inc. (CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Company will release financial results for the three and six months ended June 30, 2012, following the close of the market on Tuesday, August 14, 2012. Martin Rosendale, Chief Executive Officer, and Andrew Maslan, Chief Financial Officer, will host a conference call beginning at 10:00 a.m. Eastern Time on Wednesday, August 15, 2012, to discuss the second quarter 2012 financial results and to answer questions. Shareholders and other interested parties may participate in the call by dialing 800-798-2801 (domestic) or 617-614-6205 (international) and entering passcode 39362501. The call will also be broadcast live on the Internet at http://www.streetevents.com, http://www.fulldisclosure.com and http://www.cytomedix.com. A replay of the conference call will be available beginning two hours after its completion through August 22, 2012 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 15244694. The call will also be archived for 90 days at http://www.streetevents.com, http://www.fulldisclosure.com and http://www.cytomedix.com. About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the … Continue reading →

TUCSON, Ariz., Aug. 9, 2012 /PRNewswire/ -- Doctors at the University of Oklahoma reported the first successful procedure for growing new blood vessels from adipose, or 'fat derived,' stem cells. These newly formed blood vessels can be used in heart bypass surgery and other complicated procedures requiring healthy vessels, according to the researchers, who presented their findings at the American Heart Association's 2012 Scientific Sessions. (Photo: http://photos.prnewswire.com/prnh/20120809/LA54820) Through liposuction, doctors can collect hundreds of millions of stem cells that can be used to generate blood vessels. The cells were "seeded" onto a 'bio-scaffold' and as they multiplied, researchers rolled them into tubes with the diameter of small blood vessels. Within weeks, new, healthy tissue began to grow into usable blood vessels. And since the cells are 'autologous', or from the same patient, there is no risk of adverse reactions or rejection. But one of the key considerations is the age of the patient and thus the age of the stem cells. Young stem cells are much more active and potent than older cells. And young blood vessels are much more functional than older vessels. One potential downside is that these blood vessels take time to grow in the lab. "They … Continue reading →

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today reported financial results for the second quarter ended June 30, 2012. The company also highlighted progress with ADCETRIS (brentuximab vedotin) commercialization activities, ongoing and planned clinical trials and upcoming milestones. As the leader in developing antibody-drug conjugate therapies, we along with our many collaborators are using our technology to change the way cancer is treated, said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. We remain focused on making ADCETRIS available to patients, and we are delivering on this priority both through continued commercial initiatives for patients in the labeled indications, as well as through our robust clinical development of ADCETRIS in earlier lines of therapy and other CD30-positive malignancies. We are also focused on advancing our robust pipeline of ADC candidates and leveraging our ADC technology in collaborations to further advance the treatment of cancer. Recent ADCETRIS Highlights Other Recent Highlights Upcoming Milestones Second Quarter and First Six Months 2012 Financial Results Revenues in the second quarter of 2012 were $48.8 million, compared to $13.1 million in the second quarter of 2011. Revenues for the six month period ended June 30, 2012 were $97.1 million, compared to … Continue reading →

GAITHERSBURG, MD--(Marketwire -08/06/12)- Cytomedix, Inc. (CMXI) (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 the Centers for Medicare & Medicaid Services ("CMS") has issued a final National Coverage Determination ("NCD") for autologous blood-derived products for chronic non-healing wounds. As previously reported, on May 9, 2012 CMS posted its proposed NCD, which was followed by a 30-day public comment period that ended on June 8th. In the final decision memo released August 2nd, CMS responded to these comments, refined its decision and confirmed coverage for autologous platelet rich plasma ("PRP") in patients with diabetic, pressure and/or venous wounds via its Coverage with Evidence Development ("CED") program. CED is a process through which CMS provides reimbursement coverage for items and services while generating additional clinical data to demonstrate their impact on health outcomes. In the final decision memo, CMS noted that it " ...has reviewed the medical literature on autologous PRP in patients with chronic wounds and believes that CED is appropriate for PRP treatment," and concluded that, "when reviewed as a body of evidence, it does indicate that PRP shows promise in the populations … Continue reading →