|Neurologix surges on Parkinson Phase II trial results. EnteroMedics soars on updated obesity study data|
|By BioMedReports.com Staff|
|Tuesday, 22 June 2010 18:10|
Below is a list of the companies that made news in the healthcare sector on Tuesday, June 22, 2010.
Neurologix, Inc. (OTC Bulletin Board:NRGX.ob), today announced positive results in a Phase 2 trial of its investigational gene therapy for advanced Parkinson's disease (PD), NLX-P101. Study participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery. In the trial, this benefit was seen at one month and continued virtually unchanged throughout the six month blinded study period. The results also demonstrated a positive safety profile for NLX-P101, with no serious adverse events related to the gene therapy or surgical procedure reported. Patients enrolled in the trial had moderate to advanced PD and were not adequately responsive to current therapies.
Neurologix, Inc., is a clinical-stage biotechnology company dedicated to the discovery, development and commercialization of gene therapies for serious disorders of the brain and central nervous system (CNS). Neurologix's investigational AAV (adeno-associated virus) vector gene therapy, NLX-P101, is a novel, non-dopaminergic approach that uses an inhibitory gene (glutamic acid decarboxylase or "GAD") to selectively alter the neural circuitry affected in PD and, thereby, normalize brain physiology. Neurologix's technology is the only gene therapy strategy currently in development which bypasses the dopamine system.
"We are extremely pleased that years of research by our group with AAV vector gene transfer technology has led to the unprecedented milestone of a statistically significant improvement in a double-blind, placebo-controlled trial of gene therapy for any neurological disorder," said Michael G. Kaplitt, MD, PhD, scientific co-founder of Neurologix, Inc., neurosurgeon, New York-Presbyterian Hospital/Weill Cornell Medical Center and Associate Professor and Vice Chairman for Research, Department of Neurological Surgery, Weill Cornell Medical College. "We now have solid scientific evidence to support NLX-P101 as an important, potential treatment for this devastating disease."
Shares of Neurologix reached an intra-day high of $1.60 before falling back and settling at $1.15, up 40 cents or 53% on the day.
EnteroMedics Inc. (NASDAQ:ETRM), announced today updated data from its EMPOWER™ study in obesity.
"The Maestro System has been studied in over 400 people to date, with some patients into their fifth year of follow-up," said President and CEO Mark B. Knudson, Ph.D. "Across a number of studies, we have observed clinically significant weight loss and control of obesity related co-morbidities as well as a safety profile that distinguishes this system from all other bariatric surgical procedures. We are particularly encouraged by the strong, positive feedback from the metabolic and bariatric surgery community."
The Maestro® System, which delivers VBLOC® vagal blocking therapy, continues to meet all of its safety goals, with no therapy-related serious adverse events reported across all of the various study populations.
Shares of EnteroMedics have been under pressure since October 2009 when the company released preliminary data from its pivotal study of its Maestro System for the treatment of obesity. The stock was hit hard as the study did not meet primary and secondary efficacy endpoints. In the past 52 weeks shares have traded as high as $5.58.
In trading Tuesday, shares of EnteroMedics soared more than 107% from Mondays close of 29 cents, ending the day at 60.5 cents.
Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) through its US-based subsidiary AMDL Diagnostics Inc., released an update to its Onko-Sure™ in vitro diagnostic (IVD) commercialization efforts in India. The Company's exclusive distributor in India, New Delhi based Gaur Diagno, Pvt Ltd (GDL) plans to implement a government supported general cancer screening program for select populations with high cancer rates.
Shares of Radiant gained more than 15% or 17 cents, closing the day at $1.26.
Affymax, Inc. (Nasdaq:AFFY) today announced that it has received $30 million in development milestone payments from Takeda Pharmaceutical Company as part of the companies’ exclusive global agreement to develop and commercialize Hematide™/peginesatide, Affymax’s investigational drug for the treatment of anemia in chronic renal failure patients. The payments were triggered by the achievement of database lock in the PEARL and EMERALD Phase 3 clinical trials, which evaluated Hematide to treat anemia in chronic renal failure patients.
Affymax and Takeda are collaborating on the development of Hematide and will co-commercialize the product in the United States upon approval. Takeda holds an exclusive license to develop and commercialize Hematide outside the United States, including Japan.
Biovail Corporation (NYSE, TSX: BVF) and MedGenesis Therapeutix Inc. today announced that The Michael J. Fox Foundation (MJFF) for Parkinson's Research has awarded a $2.1 million grant to Biovail Laboratories International SRL (BLS) and MedGenesis Therapeutix, Inc. to further their collaboration in the development of glial-cell line derived neurotrophic factor (GDNF). The grant will be made over a 3-year period; with the total amount being subject to the attainment of specific milestones.
Hansen Medical, Inc. (NASDAQ:HNSN) announced the successful completion of a pre-clinical in-vivo study evaluating its new vascular robot, which demonstrated improvements in catheter navigation, reductions in vessel trauma during catheter manipulation, and improvements in access time for some vessels, as compared to manual catheter manipulation during endovascular procedures. Results also showed that the company's vascular robot has the potential to standardize catheter navigation, which may lead to more predictable procedures. The early, but encouraging results were presented June 12, 2010 at the Society of Vascular Surgery's 2010 Vascular Annual Meeting in Boston.
ImmunoCellular Therapeutics (OTCBB: IMUC), a clinical-stage biotechnology company focused on developing new immune-based products to treat cancer, today announced it has entered into an exclusive licensing agreement with Targepeutics, Inc. for ImmunoCellular’s acquisition of Targepeutics’ worldwide intellectual property rights surrounding the IL-13 receptor, alpha 2 (IL13Ra2). The agreement includes Targepeutics’ rights under an issued U.S. patent and under certain other issued or pending patents and applications.
LifeVantage Corporation (OTC Bulletin Board:LFVN.ob) announced today that a peer-reviewed manuscript was published in the Journal of Dietary Supplements examining the beneficial effects of Protandim® on a mouse model of Duchenne Muscular Dystrophy (DMD), an X-linked inherited disease affecting one in 3,500 males. Symptoms usually appear before age 5, and progressive muscle weakness usually requires wheelchair use by age 12. The disease is usually fatal by the early twenties due to fibrosis-induced failure of the heart and diaphragm. Protandim® is a patented dietary supplement comprised of five highly synergistic herbal ingredients that activate the transcription factor Nrf2, a signal to the cell's DNA to regulate a network of protective genes.
Dr. Brian Tseng and his colleagues at Massachusetts General Hospital, Harvard Medical School, and the University of Colorado Denver, demonstrated the ability of Protandim® to suppress levels of both oxidative stress and fibrosis, which can lead to heart failure and other symptoms exhibited in DMD, while increasing the activity of a protective antioxidant enzyme called paraoxonase-1 (PON1) in the mdx mouse model of DMD.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that the company presented an update on its ZYBRESTAT ophthalmology program, including encouraging preclinical data showing that the company's topical formulation achieved target retina/choroid concentrations with minimal systemic exposure. OXiGENE has two topical formulations of ZYBRESTAT in development -- an eye drop and a minitab -- both of which have demonstrated attractive pharmacokinetic and safety properties and efficacy in destroying abnormal vasculature in a rat choroidal melanoma model. The company believes that a topical formulation could be ready for clinical development in early 2011.
Pro-Pharmaceuticals, Inc. (OTCBB: PRWP), the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced it has received its first purchase order for DAVANAT® from PROCAPS S.A., a large, international pharmaceutical company based in Barranquilla, Colombia. Pro-Pharmaceuticals has received a purchase order for $200,000 which will be the upfront payment for this first shipment of DAVANAT®.
Regulus Therapeutics Inc. and sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that they have entered into a global, strategic alliance to discover, develop, and commercialize microRNA therapeutics. Both Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced that, as a result of the newly formed alliance Regulus has established with sanofi-aventis, each company will receive a payment of $1.8 million from Regulus. This represents 7.5% of the $25 million upfront payment from sanofi-aventis to Regulus. In addition, Alnylam and Isis are each eligible to receive a similar percentage of potential future success-based milestone payments from the alliance.
Alnylam stated: "We and Isis congratulate Regulus on forming this important new alliance with sanofi-aventis. Regulus stands as the leader in the emerging field of microRNA therapeutics, and this new partnership reflects the high level of interest across the pharmaceutical industry for innovative medicines based on this new biology"
SafeStitch Medical, Inc. (OTCBB:SFES) today announced the commercial sales launch of the AMID Stapler™ Inguinal and Ventral Hernia Repair System. The AMID Stapler is available for immediate shipment to US surgeons.
"Because hernia repairs using the AMID Stapler™ require less surgical wound retraction, the procedure is potentially less painful due to reduced tissue contusion," noted Dr. Charles Filipi, SafeStitch Chief Medical Officer and past president of the American Hernia Society. Jeffrey Spragens, the company’s President and CEO, added that "There are approximately 600,000 patients undergoing inguinal hernia repair in the US each year. We see the AMID Stapler™ as a new transitional device in the treatment of hernias in that it may also result in faster patient turnaround in the Operating Room. A fast procedure time and less tissue manipulation should provide patients with a more comfortable recovery with the potential to return to work in less time."
SonoSite, Inc. (NASDAQ:SONO), the world leader and specialist in bedside and point-of-care ultrasound, and United Medical Instruments (UMI), a worldwide provider of new and pre-owned ultrasound systems, today announced a new agreement for UMI to distribute SonoSite’s products into certain small office markets.
VIVUS, Inc. (Nasdaq:VVUS) today announced that data on Qnexa®, an investigational drug candidate, will be featured in a total of six presentations – including an oral presentation, three moderated poster presentations and two poster presentations – during the 70th Scientific Sessions of the American Diabetes Association (ADA), being held from June 25-29, 2010 in Orlando, Florida.
"VIVUS is pleased to have such a robust presence at this year's ADA annual meeting and to have leading experts in obesity, diabetes and cardiometabolic disease presenting data that we believe further highlight the potential impact Qnexa, if approved, may have on the life-threatening comorbidities associated with obesity," commented Leland Wilson, chief executive officer of VIVUS.
Access Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP), a biopharmaceutical company specializing in products for cancer and supportive care, is sponsoring an Oral Mucositis Symposium today for researchers and health care professionals attending the Multinational Association of Supportive Care in Cancer (MASCC) Conference in Vancouver, B.C. later this week.
AmStem Corporation (OTCBB:AMST), a world leader in stem cell research using stem cells collected from the umbilical cord immediately after birth, announced today the launch of a new consumer-based study of its flagship cosmeceutical product SteMixx™.
Baxter International (NYSE:BAX), will host a quarterly conference call to discuss its second quarter 2010 financial results on Thursday, July 22, 2010 at 8:30 a.m. Eastern Time (7:30 a.m. Central Time).
Derma Sciences, Inc. (Nasdaq:DSCI), a medical device and pharmaceutical company focused on advanced wound care, announces that the U.S. Patent and Trademark Office has issued patent No. 7,714,183 related to the Company’s MEDIHONEY® Calcium Alginate Dressing.
Diamyd Medical AB (STO:DIAMB)(Pink Sheets:DMYDY) has signed an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company, to develop and commercialize the Diamyd® diabetes therapy.
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the promotion to vice president of two executive directors – Godfrey Amphlett, Ph.D., and Robert J. Lutz, Ph.D. – who have played central roles in establishing ImmunoGen’s highly successful product development capabilities.
Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative biomedical surgical oncology products, today announced that Platinum-Montaur Life Sciences, LLC (Montaur) has agreed to exchange all $10 million of its outstanding 10% senior secured convertible notes and $3 million perpetual convertible preferred stock for a single new series of preferred stock convertible into common shares of Neoprobe Corporation.
NexMed, Inc. (Nasdaq: NEXMD), a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that Deirdre Y. Gillespie, M.D., President and Chief Executive Officer of publicly-held La Jolla Pharmaceutical Company, has been appointed to the Company's Board of Directors, effective immediately.
PPD, Inc. (Nasdaq: PPDI) will release its second quarter 2010 financial results on Tuesday, July 27, 2010, after the market closes.
Pro-Pharmaceuticals, Inc. (OTCBB: PRWP), the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced it has received its first purchase order for DAVANAT® from PROCAPS S.A., a large, international pharmaceutical company based in Barranquilla, Colombia.
Vicor Technologies, Inc. (OTCBB: VCRT) today announced that David H. Fater, its President, Chief Executive Officer, and Chairman, will be presenting at the Sidoti & Company Semiannual New York Micro-Cap Conference on June 25, 2010 at the Grand Hyatt New York hotel in New York, NY.
Walgreens (NYSE:WAG) (NASDAQ:WAG): "For consumers, we are planning another comprehensive flu shot program this fall, as one example of our expanded vaccination and immunization program."
Walmart (NYSE:WMT) and Eli Lilly and Company (NYSE:LLY) announced today they're teaming up to provide an affordable insulin option for people with diabetes.
Weikang Bio-Technology Group Co., Inc. (OTC Bulletin Board: WKBT) a leading developer, manufacturer and marketer of Traditional Chinese Medicine (TCM), Western prescription and OTC pharmaceuticals and other health and nutritional products in the People's Republic of China, today announced that the Company had filed an application to list its common stock on the NASDAQ Capital Market.
XYTOS (OTC: XYTS) is pleased to announce the appointment of Farouk Dakhil, PhD as the Company’s New Chief Scientific Officer and the Head of the XYTOS Scientific Advisory Board.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.