Category Archives: FDA Stem Cell Trials

Stocks go up, stocks go down -- and so do analysts' opinions of them. This series, brought to you by Yahoo! Finance, looks at which upgrades and downgrades make sense, and which ones investors should act on. This morning, Wall Street was feeling mighty optimistic, so we'll be examining the new buy ratings that have just come out on Dunkin' Brands (DNKN - News), SandRidge Energy (SD - News), and finally, Aastrom Biosciences (ASTM - News). And we're off!Attacking these ratings in first (worst) order, we begin with Aastrom Biosciences, a pioneer in the field of stem cell research. This morning, Aastrom got a buy rating from the folks at Ascendiant Capital. With a name like "Ascendiant," you'd expect these analysts to be an optimistic bunch, and you'd be right. Because Ascendiant didn't just give Aastrom any old buy rating, but a strong buy, and a $4.25 price target that values the stock at nearly twice its current market cap. Why? According to StreetInsider.com, Ascendiant is picking Aastrom primarily out of faith in its "key product, ixmyelocel-T ... an autologous, bone marrow-derived cell therapy product being developed for the treatment of critical limb ischemia (CLI) and dilated cardiomyopathy (DCM)." The … Continue reading →

SAN DIEGO, May 16, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (OPTR) today announced the results of a retrospective subpopulation analysis of 183 patients with cancer from the company's two large Phase 3 trials, which showed the cancer patients with Clostridium difficile-associated diarrhea (CDAD) who were treated with DIFICID (fidaxomicin) tablets experienced resolution of their diarrheal symptoms approximately two days faster than those treated with oral vancomycin. These results will be presented on June 2nd at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. (Logo: http://photos.prnewswire.com/prnh/20090413/LA97352LOGO) "CDAD is a serious complication for cancer patients and potentially can disrupt the effects of cancer treatment and result in dehydration, impaired functioning, fatigue and, in severe cases, death," said Kathleen Mullane, D.O., Associate Professor of Medicine, Section of Infectious Diseases and Global Health, at the University of Chicago. "The results of this analysis indicate DIFICID may provide faster resolution of diarrhea when compared to vancomycin in a subset of cancer patients. While further studies are needed to confirm these findings, the results suggest the drug may serve as an important treatment option for this population and others at heightened risk for CDAD." The analysis assessed treatment outcomes between patients … Continue reading →

NEWARK, Calif., May 17, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced completion of the first planned interim safety review of the Company's Phase I/II spinal cord injury clinical trial, which indicated that the surgery, immunosuppression and the cell transplants have been well-tolerated. The trial, which is designed to evaluate the safety and preliminary efficacy of the Company's proprietary HuCNS-SC(R) cells (purified human neural stem cells), represents the first time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury. A summary of the data will be presented by Armin Curt, M.D., principal investigator for the clinical trial, at the Interdependence 2012 Global SCI Conference, which is being held in Vancouver, British Columbia, from May 15 to 17, 2012. The interim data is from the first cohort of patients, all of whom suffered a complete spinal cord injury in which there is no neurological function below the level of the injury. All patients enrolled were transplanted with a dose of 20 million cells at the site of injury in the thoracic spinal cord. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients were neurologically … Continue reading →

14 May 2012 Xenetic Biosciences plc ('Xenetic' or 'the Company') Appointment of Vice President for Drug Development Xenetic Biosciences plc (LSE: XEN.L), a bio-pharmaceutical company specialising in the development of high-value differentiated biological and vaccines and novel cancer drugs, announces that Dr Henry Hoppe IV has been appointed as Vice President of Drug Development for the Company. Dr Hoppe is a leading biotechnology drug development executive with over 20 years' experience in recombinant protein, monoclonal antibody and stem cell expression for clinical therapies. His is a key appointment for Xenetic that is a pivotal step in establishing the Company's new Drug Development Centre in Boston. Dr Hoppe's principal expertise lies in the processes surrounding regulatory submissions, IND filings and clinical trials, especially in the orphan and rare disease arena, exemplified in his 17 years at Genzyme Corporation (NasdaqGS: GENZ - news) where he was instrumental in the development and launch of many of their leading products. About Dr Hoppe Dr Hoppe is a biotechnology process development executive with over 20 years experience in recombinant protein, monoclonal antibody and stem cell expression for clinical therapies. He has written and reviewed IND/NDA CMC sections for numerous recombinant protein and gene therapy programs, … Continue reading →

By Jason Napodano, CFA We are initiating coverage of Neuralstem Inc. (CUR) with an Outperform rating and $3.00 price target. We believe the companys dual-technology platform focused on cell therapy and traditional pharmaceutical products provides investors with the best of both worlds an early-stage investment in a potentially revolutionary pipeline in regenerative medicine and an attractive and under-valued small molecule pipeline sure to attract interest from larger pharmaceutical partners given the novel mechanism of action and broadapplication potential into multiple indications. Neuralstems cell therapy technology enables the isolation and large-scale expansion of human neural stem cells from all areas of the developing human brain and spinal cord. Neuralstems technology was created to assist the body in producing new cells to replace malfunctioning or dead cells as a way to treat disease and injury. The companys preclinical research shows these cells both help create new circuitry (neurogenesis) and express factors that protect existing cells (neuroprotective). We believe this platform may be useful in treating many diseases and conditions of the central nervous system (CNS) and neurodegenerative disorders. The lead development programs are currently focused on amyotrophic lateral sclerosis (ALS) and spinal cord injuries (SCI). Preliminary data from the companys phase 1 … Continue reading →

MADISON, Wis., May 15, 2012 /PRNewswire/ -- Novelos Therapeutics, Inc. (NVLT.OB), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that it has successfully completed the first cohort in a U.S. multi-center Phase 1b dose-escalation trial of its cancer-targeted molecular radiotherapeutic compound I-131-CLR1404 (HOT) in cancer patients with advanced solid tumors. The first two-patient cohort was successfully dosed with approximately 20 mCi of HOT, triggering enrollment into the second cohort at approximately 40 mCi. Details of the trial design are available on http://www.clinicaltrials.gov ID: NCT01495663, or at http://www.novelos.com in the 'Clinical Trials' section. Glenn Liu, M.D., University of Wisconsin Carbone Cancer Center, is the trial's principal investigator. Detailed trial results are expected to be presented at a scientific venue at a later date. "Patients with advanced solid tumors need safer and more effective therapies," said Dr. Liu. "Based on animal data, results from a completed Phase 1a dosimetry trial, and now initial data from this Phase 1b trial, HOT appears to deliver radiation directly and selectively to cancerous tumors. Data from the first cohort indicates HOT was well-tolerated, without any grade 3 or 4 toxicities, enabling enrollment of the first patient in the second … Continue reading →

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq: SGEN - News) today announced that interim results from an investigator-sponsored phase II clinical trial of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the Society for Investigative Dermatology annual meeting being held May 9-12, 2012 in Raleigh, NC. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS has not been approved for use in CTCL. The trial enrolled CTCL patients with mycosis fungoides (MF) or Sezary syndrome. At the time of data analysis, 17 patients had been enrolled, including 16 with MF and one with Sezary syndrome. Patients had received a median of six prior therapies, including a median of four prior systemic therapies. The primary endpoint of the trial is clinical response rate. Secondary endpoints include correlation of clinical response with CD30 expression levels, duration of response, progression-free survival and safety. The study is led by principal investigator Dr. Youn H. Kim, Professor, Department of Dermatology, and Director, Multidisciplinary Cutaneous Lymphoma Program at Stanford University School of Medicine in Stanford, CA. Key findings include: This is the second data set reported with ADCETRIS in CTCL patients. At the T-Cell Lymphoma Forum in January 2012, … Continue reading →

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN - News) today reported financial results for the first quarter ended March 31, 2012. The company also highlighted the ADCETRIS (brentuximab vedotin) product launch, ongoing and planned clinical development activities and upcoming milestones. First quarter 2012 ADCETRIS net product sales were $34.5 million, an increase of 4 percent from $33.2 million in the fourth quarter of 2011. ADCETRIS gross product sales increased by 12 percent in the first quarter of 2012 compared to the fourth quarter of 2011, but this increase was offset by an expected increase in gross-to-net discount in the first quarter of 2012 driven by Public Health Services program discounts that became effective during January. The commercialization of ADCETRIS continues to be strong, and we are pleased by the acceptance and utilization of ADCETRIS among oncologists and patients with relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. Our long-term vision for ADCETRIS is to expand its use into earlier lines of HL and sALCL therapy and into other CD30-positive malignancies. To that end, we are conducting a robust clinical development program with ADCETRIS, including … Continue reading →

By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The Food and Drug Administration said certain patients treated with Celgene Corp.'s (CELG) cancer drug Revlimid have an increased risk of developing some new types of cancers. Revlimid is approved to treat patients with multiple myeloma, a bone-marrow cancer in combination with another drug. The product is also approved to treat another bone-marrow condition called myelodysplastic syndromes. In a drug-safety communication posted to the FDA's website Monday, the agency said data from clinical trials of Revlimid showed newly diagnosed patients treated with Revlimid had an increased risk of developing second types of cancer compared to similar patients who received a placebo, or fake drug. The agency said there was an increased risk of developing acute myelogenous leukemia, a type of blood cancer, myelodysplastic syndromes and Hodgkin lymphoma. The FDA said the information has been added to Revlimid's label, which is aimed at giving information about products to doctors, and that patient information is being updated. The FDA said doctors "should consider both the potential benefit of Revlimid and the risk of second primary malignancies when deciding to treat patients with this drug, and monitor patients for this risk." Patients … Continue reading →

NEW YORK, NY--(Marketwire -05/03/12)- Biotech stocks have continued to provide investors with strong gains in 2012. The iShares NASDAQ Biotechnology Index (IBB) is up nearly 20 percent year-to-date. The passage of the America Invents Act will look to benefit the Biotechnology Industry going forward "by enhancing patent quality and the efficiency, objectivity, predictability and transparency of the U.S. patent system," BIO President and CEO Jim Greenwood stated in a press release. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Biosante Pharmaceuticals Inc. (BPAX - News) and Advanced Cell Technology, Inc. (ACTC.OB - News). Access to full reports can be found at: http://www.ParagonReport.com/BPAX http://www.ParagonReport.com/ACTC "Small biotechnology companies rely heavily on their patents to attract investment," and "they will benefit from the improvements to our nation's patent system made by this legislation," added Greenwood. The America Invents Act (AIA) will shift the patent system from a "first to invent" to a "first to file" system, the first major change to the patent system in over 60 years. Under the "first to invent" system the first inventor to file for a patent will be awarded priority, regardless if the inventor was the first to invent it. … Continue reading →