Category Archives: FDA Stem Cell Trials

NEW YORK, NY--(Marketwire - Nov 27, 2012) - Immunovative, Inc. ("IMUN" or the "Company") ( OTCQB : IMUN ) announces today that Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, Ltd. ("ITL") was invited to speak at the inaugural Immunotherapies and Cancer Vaccine Congress to be held at the Sheraton Brussels Hotel on December 5-6 in Brussels, Belgium (the "Congress").Dr. Har-Noy will be joining industrial and academic leaders in immunotherapy and cancer vaccine development to discuss the latest ideas on how to maximize the immune response to cancer, optimize the clinical development timelines of immunotherapy drugs and boost the commercial success of immunotherapies. The recent FDA approvals of Dendreon's Provenge cancer vaccine for prostate cancer and Bristol Myers Squibb's Yervoy immunotherapy drug for melanoma has sparked a resurgence of interest in immunotherapies and cancer vaccines.The organizer of the Congress, Informa Life Sciences, predicts that by 2014 that 3 of the top 10 cancer drugs will be immunotherapy drugs.Major pharmaceutical companies are launching immunotherapy drug development programs to enter this lucrative market and many of the leading companies are making presentations at the Congress.A full program can be viewed on-line at: http://www.informa-ls.com/appdata/downloads/CQ3486_Immunotherapies_VIP_TT37.pdf Dr. Har-Noy will be speaking at the Novel … Continue reading →

5:25 pm Robbins & Myers certifies substantial compliance with second request in connection with NOV merger (RBN) Co announced that it and National Oilwell Varco (NOV) have certified substantial compliance with the U.S. Department of Justice's request for information (commonly called a "second request") pursuant to the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR Act"), in connection with the proposed merger transaction in which National Oilwell Varco, Inc. would acquire all of the outstanding shares of Robbins & Myers for $60.00 per share in cash. Pursuant to the HSR Act, the premerger waiting period will expire at 11:59 p.m., Eastern Time, on December 27, 2012 (which is thirty days after the certification of substantial compliance), absent a challenge by the U.S. Department of Justice. Robbins & Myers also announced today that it is delaying its 2013 annual meeting of shareholders to March 26, 2013. 5:20 pm Zoltek misses by $0.01, misses on revs (ZOLT) Reports Q4 (Sep) earnings of $0.13 per share, $0.01 worse than the Capital IQ Consensus Estimate of $0.14; revenues rose 2.6% year/year to $44.2 mln vs the $46.67 mln consensus. 5:19 pm Medley Capital announces offering of 5 mln shares of common stock (MCC) … Continue reading →

MADISON, Wis., Nov. 27, 2012 /PRNewswire/ --Novelos Therapeutics, Inc. (NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that Harry Palmin, President and CEO of Novelos, will present a corporate update at the Benchmark 2012 Micro Cap Discovery Investor Conference on Thursday, November 29, 2012. Mr. Palmin is scheduled to present at 10:00 a.m. CT. The conference will take place at the InterContinental Hotel in Milwaukee and is being sponsored by Benchmark Company, LLC. A live webcast of the Novelos presentation may be accessed via http://www.novelos.com The webcast will be archived for 90 days following the presentation. About Novelos Therapeutics, Inc.We are a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer. Our cancer-targeted compounds are selectively taken up and retained in cancer cells, including cancer stem cells, versus normal cells. Thus, our therapeutic compounds appear to directly kill cancer cells while minimizing harm to normal cells. This offers the potential for a paradigm shift in cancer therapy by providing efficacy versus all three major drivers of mortality in cancer: primary tumors, metastases and stem cell-based relapse. I-124-CLR1404 (LIGHT) is a small-molecule, broad-spectrum, cancer-targeted PET imaging agent. We believe LIGHT … Continue reading →

BOONTON, N.J. and CAMBRIDGE, Mass., Nov. 27, 2012 /PRNewswire/ -- Unigene Laboratories, Inc. (UGNE) and Tarix Pharmaceuticals today announced that the companies have entered into a definitive licensing agreement to develop an oral formulation of TXA127, Tarix's lead peptide drug candidate. The oral formulation of TXA127 is being developed jointly by Unigene and Tarix under a previously agreed upon feasibility program whereby the companies leveraged Unigene's Peptelligence technology platform to enable enhanced oral delivery of TXA127. According to terms of the licensing agreement, Tarix will have an exclusive worldwide license to Unigene's Peptelligence technology covering the use of that technology with Angiotensin (1-7), the pharmaceutical ingredient in TXA127, as well as its functional equivalents, analogues or derivatives. In return for the license, Tarix will pay Unigene a percentage of revenues, if any, derived from the direct sales of any oral dose form of an approved Angiotensin (1-7) product by Tarix or from any up-front, milestone or royalties received by Tarix from a third-party sub-licensee of Unigene's Peptelligence technology with respect to any Angiotensin (1-7) product. There is no upfront payment being made by Tarix to Unigene in connection with the execution of the license. Ashleigh Palmer, Unigene's Chief Executive Officer, … Continue reading →

A genetically-engineered HIV vaccine under study by Texas researchers works in a novel way. It targets specific cells exactly where the virus enters the body, stimulating them to generate an immune response so the virus can't take hold. If the strategy bears out, the vaccine will be a single dose and last a lifetime, says Marie-Claire Gauduin, PhD, assistant scientist at Texas Biomedical Research Institute. ''Many other HIV vaccines try to block the infection when the virus is already in," she says. "Here we try not to be infected to begin with," Gauduin tells Take Part. RELATED:Breakthrough: Early HIV Treatment Virtually Erases Risk of Passing Virus On About 33 million people worldwide are living with HIV/AIDS, according to estimates by the Joint United Nations Programme on HIV/AIDS. Most do not know it. The new vaccine, if perfected, could be given to children at puberty to stem this toll, Gauduin says. Most new cases of HIV infections worldwide are transmitted by sexual intercourse through outer layers of cells known as epithelial cells. These line the surfaces of structures throughout the body. The target of the new vaccine is the mucosal layers of the epithelium in the genital and rectal areas, where … Continue reading →

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) announced today that ADCETRIS (brentuximab vedotin) has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of mycosis fungoides (MF). MF is the most common type of cutaneous T-cell lymphoma (CTCL). Seattle Genetics and its ADCETRIS collaborator, Millennium: The Takeda Oncology Company, are conducting the ALCANZA trial, a phase III clinical trial of ADCETRIS for patients with CD30-positive relapsed CTCL, including MF. ADCETRIS is not approved for the treatment of CTCL. This orphan drug designation is a part of our ADCETRIS regulatory strategy, designed to complement the Special Protocol Assessment for the ongoing ALCANZA study, said Clay B. Siegall, President and Chief Executive Officer of Seattle Genetics. The encouraging data from investigator-sponsored trials of ADCETRIS in CTCL, which will be presented at ASH, provide further support for our activities in this patient population. FDA orphan drug designation is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States. This designation provides Seattle Genetics with the opportunity for seven years of marketing exclusivity, grant funding to defray costs of clinical trial expenses, tax credits for … Continue reading →

The possibilities, they say, are endless. And an Indiana-based group of doctors and researchers hope to be among the first U.S. companies to be approved by the U.S. Food and Drug Administration to use stem cells for a variety of treatments. "We're at the beginning of the road," said Dr. Shah Rahimian, president of research and development for Antria on Hospital Road. "If we are not the very first, we are one of the first, the pioneers in the U.S." Stem cells are the wild card of the cell world. Some grow into specific tissues, but others -- called pleuripotent stem cells -- can grow into anything, such as blood vessels or cartilage. But their use and study has often been controversial, because often the cells are taken from human embryos. Antria uses what are called adult stem cells, derived from an adult rather than an embryo. And they take them from one of the more abundant features of the human body: fat. "It was always right in front of us, but we never saw it," said Rahimian said. "There is no other tissue that grows so fast." Rahimian said that previously researchers have looked to take adult stem cells … Continue reading →

GAITHERSBURG, MD--(Marketwire - Nov 8, 2012) - Cytomedix, Inc. ( OTCQX : CMXI ) (the "Company"), a leading developer of biologically active regenerative therapies, announced today that the FDA has cleared the use of its Angel Concentrated Platelet Rich Plasma (cPRP) System for processing a small sample of blood or a mixture of blood and bone marrow aspirate.PRP produced from either blood or a mixture of bone marrow aspirate may be combined with bone graft material and used in appropriate orthopedic procedures as deemed necessary by a clinician, such as spinal fusion, healing of non-union bone fractures and other bone grafting applications. "We are pleased to reach this important regulatory milestone that will broaden utilization of the Angel cPRP System in a range of orthopedic procedures," said Martin Rosendale, Chief Executive Officer of Cytomedix. "This is a significant market opportunity for Cytomedix as Angel cPRP will be positioned as a 'best in class' device that offers important competitive advantages including high platelet concentration capacity, efficient reduction of inflammatory cells, and an automated, closed system for all surgical settings." The Angel cPRP System is intended to be used in the clinic or intraoperatively at the point-of care for the safe and … Continue reading →

Americords one-time fee covers collection plus 20 years of storage. New York (PRWEB) November 05, 2012 One of the most exciting studies currently in progress is being led by Dr. Joanne Kurtzberg, Director of the Pediatric Bone Marrow and Transplant Program at Duke University. The study is examining whether an infusion of a childs own cord blood cells can lessen symptoms of cerebral palsy. Cerebral palsy is a non-genetic neurological disorder. It is caused by damage to one or more areas of the brain, usually occurring during fetal development or infancy. The Brain Injury Association of America estimates that cerebral palsy occurs in about 1 in 300 children up to the age of 10. In a recent interview about the study, Dr. Kurtzberg was asked about the benefit of using the patients own cord blood rather than cord blood from a donor. In response she said, When you use your own cord blood theres no risk that the cord blood cells will react against you, when you use donor cord blood there is a risk that the donor cells will react against the patient, thats called graft versus host disease and thats a major limitation and complication of a transplant … Continue reading →

SAN BRUNO, Calif., Oct. 30, 2012 /PRNewswire/ --Cord Blood Registry (CBR), the world's largest newborn stem cell bank was named 2012 Bioscience Company of the Year by AZBio, a not-for-profit trade association supporting the growth of Arizona's bioscience industry. CBR was selected by an independent panel of judges made up of leaders from Arizona's bioscience community who reviewed nominations from a broad selection of companies from across the state, and claimed the prize at the AZBio Awards at the Phoenix Convention Center on October 23rd. (Logo: http://photos.prnewswire.com/prnh/20120216/AQ54476LOGO) "The Bioscience Company of the Year award honors the for-profit bioscience company whose Arizona-based operations did the most to transform the world during the last 12 months," said Joan Koerber-Walker, president and CEO at AZBio. "CBR is a shining example of the innovative work that is driven from right here in Arizona and benefits families around the world.The CBR team delivers services offering the latest in today's technology while providing a foundation for new innovations and cures that will be even more prevalent in the future." "We are honored that AZBio recognizes our efforts to advance regenerative medicine and change lives through the power of newborn stem cells.Everyone at CBR has worked hard … Continue reading →