Category Archives: FDA Stem Cell Trials

MADISON, Wis., March 15, 2012 /PRNewswire/ -- Novelos Therapeutics, Inc. (OTCQX: NVLT.OB - News), a pharmaceutical company developing novel drugs for treatment and diagnosis of cancer, today announced that the University of Wisconsin Carbone Cancer Center, a leading medical oncology research institution, has enrolled the first patient in a Phase 1-2 positron emission tomography (PET) imaging trial of I-124-CLR1404 (LIGHT), a cancer-targeted PET imaging agent, in patients with primary or metastatic brain cancer. Details of the trial design are available at http://www.clinicaltrials.gov ID: NCT01540513, or at http://www.novelos.com in the 'Clinical Trials' section. Lance Hall, M.D., is the trial's principal investigator. This trial is being funded by an Institute for Clinical and Translational Research (ICTR) grant. "Despite recent advances in diagnostic and therapeutic techniques, prognosis of patients with many brain tumors, and particularly malignant gliomas, remains dismal. This reflects in part the diagnostic uncertainty in identifying infiltrative tumor growth of malignant gliomas which in turn affects subsequent treatment strategies," said Dr. Hall. "The goals of this study will be to validate uptake of LIGHT in human brain tumors, determine the optimal imaging parameters, and compare tumor volumes and diagnostic accuracy of PET and magnetic resonance imaging (MRI)." "We are very pleased … Continue reading →

Interview with Dr. Zannos Grekos Grekos contests that his office has done ... LEE COUNTY The Lee County Sheriffs Office is conducting a criminal investigation into the medical practice of a Bonita Springs cardiologist after one of his patients died last week. The investigation comes one day after state health authorities suspended Dr. Zannos Grekos license, according to a sheriffs investigator. The Sheriffs Office served a search warrant Thursday morning at Grekos practice, Regenocyte, 9500 Bonita Beach Road, Suite 310, to start collecting evidence of whats been going on at the practice, said Lt. Ryan Bell, with the major crimes division. We are currently conducting a criminal investigation into Dr. Grekos and his medical practice, Bell said outside of Grekos practice. We have been working with the Department of Health and the Board of Medicine and the Medical Examiners Office. Its still early in the investigation. The Sheriffs Office identified the patient who died as 77-year-old Richard Poling of Newburgh, Ind. Grekos was expected to come to work Thursday, but did not show up, Bell said. Employees arrived for work Thursday and were cooperating, he said. Were in the process of interviewing all the employees in furtherance of the investigation … Continue reading →

MIAMI--(BUSINESS WIRE)-- Stephen D. Nimer, M.D., one of the worlds premier leukemia and stem cell transplant researchers and clinicians, has been named the new director of the Sylvester Comprehensive Cancer Center. Nimer, the Alfred P. Sloan Chair in Cancer Research at Memorial Sloan-Kettering Cancer Center, will assume the key University of Miami Miller School of Medicine and UHealth-University of Miami Health System post this spring, bringing 30 years of pioneering research and clinical experience and an unquenchable passion for improving the lives of patients with cancer, and their families. The focus will not be solely on taking care of the cancer, it will be on taking care of the patient, said Nimer, whose patient-centered philosophy has won him as much acclaim as his clinical and laboratory accomplishments. That means trying to understand as fully as possible each patients cancer the biology driving the cancer, and the impact of the cancer on the patients life in order to develop a personalized therapeutic approach suited to each individual. Pascal J. Goldschmidt, M.D., Senior Vice President for Medical Affairs and Dean of the Miller School, and CEO of UHealth, said Nimer, who headed the Division of Hematologic Oncology at Sloan-Kettering for a dozen … Continue reading →

(RTTNews.com) - Stem cells have set the scientific world agog because it has been proposed as candidates to treat a myriad of diseases ranging from alzheimer's to arthritis, blindness, burns, cancer, diabetes, heart disease, liver disorders, multiple sclerosis, parkinson's, spinal cord injury and stroke. Engaged in the development of novel stem cell therapeutics targeting diseases of the central nervous system and liver is clinical-stage company StemCells Inc. (STEM). For readers who are new to this Palo Alto, California-based company, here's what to expect in the coming months... StemCells' lead product candidate is HuCNS-SC cells, a highly purified composition of human neural stem cells, currently in clinical development for spinal cord injury and for Pelizaeus-Merzbacher Disease, or PMD, a fatal myelination disorder in children. A phase I/II clinical trial of HuCNS-SC cells in chronic spinal cord injury was initiated by the company last March. The trial, which is the world's first neural stem cell trial in spinal cord injury, is designed to enroll patients with thoracic (chest-level) neurological injuries with progressively decreasing severity of injury in three sequential cohorts. The first patient in the trial was successfully transplanted with the company's proprietary HuCNS-SC adult neural stem cells last September, and enrollment … Continue reading →

SAN DIEGO, March 6, 2012 /PRNewswire/ --Marshall Edwards, Inc. (Nasdaq: MSHL - News), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate clinical testing for oncology drug candidate ME-344, the Company's lead mitochondrial inhibitor. "I am extremely proud of our clinical operations and pre-clinical research teams in reaching this important milestone, less than seven months since our IND for ME-143 was approved by the FDA to begin clinical testing," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of Marshall Edwards. "We are prepared to initiate a Phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors immediately following approval by the FDA." Marshall Edwards also announced that it has commenced dosing of the fourth cohort in its Phase I clinical trial of intravenous ME-143 in patients with solid refractory tumors. The Company expects to collect final safety and pharmacokinetic data from this trial by June. "We continue to execute on the clinical development plan we set forth for our two most promising drug candidates," said Robert Mass, M.D., … Continue reading →

MADISON, WI--(Marketwire -03/01/12)- Novelos Therapeutics, Inc. (OTCQX: NVLT.OB - News) (OTC.BB: NVLT.OB - News), a pharmaceutical company developing novel drugs for treatment and diagnosis of cancer, today announced that three scientific posters based on research conducted by Jamey Weichert, Ph.D., and his colleagues will be presented at the American Association for Cancer Research (AACR) annual meeting in April 2012 in Chicago. These presentations will describe findings in animal and cellular model systems that illustrate Novelos' cancer-targeting technology platform and the resulting clinical-stage diapeutic agents capable of imaging and treating a wide range of malignancies. An abstract of each presentation will be published in the 2012 Proceedings of the AACR. Dr. Weichert is the Chief Scientific Officer of Novelos, founder of Novelos' technology, and is an Associate Professor of the Department of Radiology in the School of Medicine and Public Health at the University of Wisconsin, Madison. Dr. Weichert and his University colleagues are all members of the UW Carbone Cancer Center. I-124-CLR1404 and I-131-CLR1404: Broad spectrum diapeutic agents for cancer cell-targeted PET imaging and molecular radiotherapy (Abstract #5740) Dr. Weichert and his colleagues will present data appearing to demonstrate broad spectrum, selective uptake and retention of the chemical structure shared … Continue reading →

More Topics: Choose a Sector Accounting Firms Advertising/Media/Communications Capital CEO/Board General Business Health/Biotech Internet/Technology Investment Firms Law Firms Mergers & Acquisitions Money Managers People Private Companies Public Companies Venture Capital Posted March 1, 2012 SUNRISE, Fla., -- Dear Shareholders, It is with great enthusiasm that I am pleased to inform you about Bioheart's progress during 2011 and announce several new initiatives for 2012. We have boosted our senior management team, entered into several valuable partnerships and agreements, identified new markets and alternative sources of revenue and seen tangible results regarding continued clinical trials. 2011 was a year of steady, continuous movement for the company. We completed an Investigational New Drug (IND) application to the FDA for the ANGEL trial. The clinical protocol is designed to assess the safety and cardiovascular effects of intramyocardialimplantation of autologous adipose derived stem cells (LipiCellTM) in patients with chronic ischemic cardiomyopathy. LipiCellTM is currently being evaluated in the Phase I/II trial in Mexico in which 15 patients have been treated. These patients are demonstrating improvements in ejection fraction and exercise capacity. We generated over $1.4 million from investments and revenues this past year. Overall debt was reduced by almost $400,000 and our monthly burn rate … Continue reading →

SUNRISE, Fla., March 1, 2012 (GLOBE NEWSWIRE) -- Dear Shareholders, It is with great enthusiasm that I am pleased to inform you about Bioheart's progress during 2011 and announce several new initiatives for 2012. We have boosted our senior management team, entered into several valuable partnerships and agreements, identified new markets and alternative sources of revenue and seen tangible results regarding continued clinical trials. 2011 was a year of steady, continuous movement for the company. We completed an Investigational New Drug (IND) application to the FDA for the ANGEL trial. The clinical protocol is designed to assess the safety and cardiovascular effects of intramyocardialimplantation of autologous adipose derived stem cells (LipiCell(TM)) in patients with chronic ischemic cardiomyopathy. LipiCell(TM) is currently being evaluated in the Phase I/II trial in Mexico in which 15 patients have been treated. These patients are demonstrating improvements in ejection fraction and exercise capacity. We generated over $1.4 million from investments and revenues this past year. Overall debt was reduced by almost $400,000 and our monthly burn rate was reduced by 20%. We renewed our $980,000 loan from Seaside National Bank and Trust with the continued support of long time shareholders, Dan Marino and Jason Taylor, who … Continue reading →

VILLA GUARDIA, Italy, Feb. 27, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT - News) (the "Company") announced today that results from a Phase III randomised controlled trial which evaluated Defibrotide for use in preventing hepatic veno-occlusive disease (VOD) in paediatric patients undergoing haemopoietic stem-cell transplantation (HSCT) were published in the medical journal, The Lancet (Vol 379). The results of Corbacioglu et al. show that Defibrotide leads to a 40% a reduction in the incidence of VOD thirty days after HSCT in patients receiving Defibrotide, compared with those who did not receive Defibrotide. Additionally, in allogeneic HSCT recipients (70% of study population), the incidence and severity of acute graft-versus-host disease (GvHD) were significantly lower in the Defibrotide arm. These finding supports the prophylactic use of Defibrotide in the HSCT transplant setting. In a commentary article to the study, Drs. Uwe Platzbecker and Martin Bornhauser from Medizinische Klinik und Poliklinik I, Universitatsklinikum "Carl Gustav Carus" Dresden, Germany, conclude "Most importantly, defibrotide prophylaxis was well tolerated and did not lead to an increased risk of bleeding. Restriction by the legislative authorities means that there are few randomised trials in children, and thus Corbacioglu and colleagues' investigation is a pivotal European study, one that … Continue reading →

NEW YORK--(BUSINESS WIRE)-- IntelliCell BioScience, Inc. (OTCQB: SVFC.PK - News) (PINKSHEETS: SVFC.PK - News); (“IntelliCell”) or the (“Company”), A full page Daily News article, titled “Stem Sells” written by Sean Brennan published February 19, 2012, http://www.nydailynews.com/sports/college/manhattan-basketball-torgrim-sommerfeldt-turned-stem-cell-treatment-back-court-article-1.1025227, describes how Torgrim Summerfeldt’s budding basketball career was saved through Dr. Anthony Maddalo’s treatment using IntelliCell BioSciences proprietary SVF Cells (Stem Cell Therapy). Mr. Summerfeldts, a former star player for the Norwegian National Basketball Team, had undergone six knee surgeries and lived in constant pain. He had forfeited his Wake Forest basketball scholarship. Manhattan College took a chance on him and invited him to join their team. Due solely to the two IntelliCell SVF (Stem Cell) treatments in New York City by Dr. Maddalo near the end of 2010 and the beginning of 2011, he started his first game for Manhattan College pain free on January 20, 2012. Dr. Steven Victor, CEO of IntelliCell BioSciences, said “We are very proud that our proprietary technology used by Dr. Maddalo was able to rehabilitate Torgims’s knees and alleviate his pain. Sports related injuries are a predominate focus for our Company. Doctors using our proprietary technology have treated several professional and college athletes with excellent results. Patients … Continue reading →