Category Archives: FDA Stem Cell Trials

by Azer N. Parrocha MANILA Following his recent resignation as (DOH) Consultant for Non-Communicable Diseases, Dr. Anthony Leachon said that he and medical societies would step up and notify the public about stem cell therapys unproven indications. Leachon, resigned as consultant of the Department of Health last Friday because he did not agree with Health Secretary Enrique Onas stand on allowing the practice of the therapy in the country despite its lack of regulation and interest to pursue clinical trials. Aside from being DOH consultant, Leachon is also vice-president of the Philippine College of Physicians (PCP). [It is] sad to say, but our regulatory agencies have not served the people's welfare but has become SCT (stem cell therapy) pushers, Leachon said, via Twitter. The Philippines has not published or done any decent clinical trials yet; SCT is being pushed without regard to safety, he added, earlier explaining the importance of trials to confirm a treatments safety. I don't want to be respectful to DOH [Secretary] as a consultant opposing him, Leachon said. [I] don't want to lend credibility to DOH. He explained that since he was not in agreement with the DOH, it was best that he let his brother, … Continue reading →

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today announced the initiation of a phase 2 clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with RCHOP (A+RCHOP), the current standard frontline therapy, for newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL). The study is intended to evaluate the complete remission rate and safety of the A+RCHOP regimen. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for the treatment of DLBCL. The encouraging data we have observed in our phase 2 trial of ADCETRIS in relapsed non-Hodgkin lymphoma, including DLBCL patients, support evaluation in earlier lines of therapy for patients with this aggressive lymphoma type, said Clay B. Siegall., Ph.D., President and Chief Executive Officer at Seattle Genetics. This trial will provide us with data on the tolerability of the combination, as well as the antitumor activity achieved by adding ADCETRIS to the current standard frontline regimen. In addition, based on interim findings from our trial in the relapsed setting in which objective responses were observed among patients with low or undetectable levels of CD30 by conventional screening methods, we will enroll high-risk DLBCL patients to this frontline trial without prescreening for CD30 expression. In … Continue reading →

LA JOLLA Fate Therapeutics became the latest biotech filing for an IPO on Wednesday. Fate seeks to raise up to $69 million, according to an Xconomy article on the IPO filing. Founded on stem cell technology, the company is in Phase 2 trials of a treatment it calls ProHema to improve the success of hematopoietic stem cell transplants, also called bone marrow transplants. These transplants are often performed on patients whose own blood-forming stem cells have been destroyed by chemotherapy for blood cancers such as leukemia and lymphoma. ProHema is used with stem cells taken from umbilical cord blood. Fate says it will use the proceeds to advance ProHema and its other products in preclinical development, and for general corporate purposes. Fate has been granted orphan designation for ProHema, also called, FT1050, the prospectus states. Fate says it has paused enrollment in the Phase 2 trial because it has developed a better formulation. Preclinical studies show the new formula more than doubles the success rate of engraftment, according to the prospectus. On Aug. 1, Fate submitted an amendment to its IND to the U.S. Food and Drug Administration, asking to use the improved product. "Subject to the consent of the … Continue reading →

SAN DIEGO, Aug. 13, 2013 /PRNewswire/ --Ambit Biosciences (AMBI), a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced results for the second quarter and six months ended June 30, 2013. The company will host a conference call today to provide an operational update and discuss financial results, its first as a public company. "The second quarter was transformative for Ambit. We successfully completed our initial public offering, which put us on solid financial footing to continue the clinical development of quizartinib, our lead drug candidate," said Michael Martino, president and Chief Executive Officer. "Our primary goal is to make this potentially important new therapy available to patients with acute myeloid leukemia (AML), who are in need of better treatment options." Second Quarter Highlights and Recent Events Quizartinib Program Update The Company has completed preliminary top line analyses of the Phase 2b clinical trial of quizartinib. This trial studied 30mg and 60mg doses administered daily to FLT3 ITD positive patients 18 years and older who were relapsed or refractory to second line treatment or a hematopoietic stem cell transplant (HSCT). Data from the top line efficacy analysis at both … Continue reading →

SUNRISE, FL--(Marketwired - Aug 9, 2013) - Bioheart, Inc. (OTCQB: BHRT) announced today that it received a validated registration from the FDA for the initial tissue bank listing.Bioheart is offering stem cell storage for patients enrolled in the studies at the centers of excellence outside the US.This new business unit will create an additional revenue stream for Bioheart.Patients can store stem cell doses in liquid nitrogen for future use in approved clinical trials.These trials focus on the use of LipiCell (adipose derived stem cells) in a variety of different degenerative diseases. Kristin Comella, Chief Science Officer, commented, "The expansion of the Bioheart facilities to include cryopreservation will bring additional revenue to the company and offer patients more options in the emerging field of regenerative medicine.Patients are able to utilize cells at a later date without additional invasive collection procedures." About Bioheart, Inc. Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues.Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX) and BioTimes subsidiary OncoCyte Corporation today announced the publication of a scientific report on the gene FSIP1 and its potential as a marker for breast cancer. The paper, published in the peer-reviewed journal Biomarkers in Medicine and available online today, describes the microarray-based approach used to identify FSIP1 as a breast cancer biomarker with significantly elevated expression in breast tumors expressing the estrogen receptor, which represents 70-80% of all breast cancers. In addition to elevated gene expression, FSIP1 protein was also expressed within tumors at significant levels whereas little to no expression was found in most normal tissues, including healthy breast tissue. Combined, these findings lay the foundation for novel diagnostic and therapeutic strategies, including the measurement of FSIP1 in the blood as a screen for the presence of cancer, as well as targeting of FSIP1 as an antigen in cancer immunotherapy approaches. Based on large unmet need, market size, and data generated thus far from patient sample screening, OncoCyte is initially focusing its efforts on identifying biomarkers that may be used to detect and monitor breast and bladder cancers. OncoCyte has been developing, characterizing, and manufacturing monoclonal antibodies for use in … Continue reading →

Miami, Florida (PRWEB) August 01, 2013 This year, GeneCells management team vowed to educate, encourage and raise awareness regarding the benefits of cord blood stem cell banking. Storing a newborns umbilical cord blood is a simple process and GeneCell is dedicated to be a partner in that process. GeneCell Internationals pricing is reasonable, with considerable discounts and payment plans, it ensures that all expecting families will be able to afford it. There are no last-minute registration fees or medical courier fees. According to the National Heart, Lung, and Blood Institute (NHLBI), National Cord Blood Awareness Month is a program that is promoted and its goal is to increase awareness in the banking of cord blood. The organization has supported research and safety with cord blood transplants. They encourage individuals to learn more about the treatments to advance the scientific knowledge in the field. "Stem cells from bone marrow and umbilical cord blood have been used extensively in the clinical arena for more than 20 years to treat a variety of diseases, in fact today, approximately 80 different diseases can be treated with umbilical cord blood," said GeneCell's Director of Operations, Jose Cirino. "The clinical applications of umbilical cord blood have … Continue reading →

SOURCE: Bio-Matrix Scientific Group, Inc. SAN DIEGO, CA--(Marketwired - Jul 31, 2013) - Bio-Matrix Scientific Group Inc. (OTCQB: BMSN) provided an update today on its subsidiary, Regen BioPharma's Investigational New Drug (IND) application (#15376) with the U. S. Food and Drug Administration (FDA) covering the HemaXellerate I stem cell product for treatment of drug refractory aplastic anemia. "We are currently in the second round of discussions with the FDA.On May 20, 2013, we filed our answers to comments the FDA made regarding the trial design and preclinical data.On June 21, 2013, we received a second set of FDA comments stating several of their questions were adequately addressed, however additional data needs to be submitted," said David Koos, Chairman and CEO of Bio-Matrix Scientific Group (Regen's parent company)."The back and forth process with the FDA is part of standard procedure associated with new drug applications.The Company is extremely appreciative of the input it has received from the FDA and looks forward to addressing their concerns within the next several months." Regen BioPharma has assembled a team of key opinion leaders in the area of adipose stem cells, which have previously reported the scientific basis for HemaXellerate in a peer-reviewed publication http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf.The … Continue reading →

Boston, United States, July 30, 2013 - (ABN Newswire) - Medistem, Inc. (OTCMKTS:MEDS - News), announced today it has entered into collaboration with Reza Abdi, M.D., Transplant Nephrologist at Brigham and Women's Hospital and Assistant Professor of Medicine, Harvard Medical School. Under the collaboration, the Company will provide Dr. Abdi with its Endometrial Regenerative Cells (ERCs) and it is expected that his research would support FDA clearance to initiate clinical trials to use ERCs as a treatment for Type 1 Diabetes. Currently, the Company has FDA clearance to initiate a dose-escalating Phase I clinical trial to use ERCs in patients with critical limb ischemia, a complication of diabetes. "Currently there are no treatments that reverse Type 1 diabetes. ERCs have a great potential to emerge as a cell therapy for type 1 diabetes by blocking the pathological autoimmune process that is causative of the disease," said Dr. Abdi. "An independent study conducted by the National Institutes of Health (NIH), has shown that our ERCs posses superior ability to modulate immune response as compared to other types of stem cells," furthermore "In previous studies, ERCs have shown the ability to produce chemical signals that inhibit autoimmune conditions such as Type 1 … Continue reading →

SAN DIEGO, CA--(Marketwired - Jul 29, 2013) - Medistem, Inc. (PINKSHEETS: MEDS) announced today it has entered into collaboration with Reza Abdi, M.D., Transplant Nephrologist at Brigham and Women's Hospital and Assistant Professor of Medicine, Harvard Medical School. Under the collaboration, the Company will provide Dr. Abdi with its Endometrial Regenerative Cells (ERCs) and it is expected that his research would support FDA clearance to initiate clinical trials to use ERCs as a treatment for Type 1 Diabetes. Currently, the Company has FDA clearance to initiate a dose-escalating Phase I clinical trial to use ERCs in patients with critical limb ischemia, a complication of diabetes. "Currently there are no treatments that reverse Type 1 diabetes. ERCs have a great potential to emerge as a cell therapy for type 1 diabetes by blocking the pathological autoimmune process that is causative of the disease," said Dr. Abdi. "An independent study conducted by the National Institutes of Health (NIH) has shown that our ERCs possess superior ability to modulate immune response as compared to other types of stem cells," furthermore, "In previous studies, ERCs have shown the ability to produce chemical signals that inhibit autoimmune conditions such as Type 1 diabetes and multiple … Continue reading →