BIO updates for Monday January 28, 2013
Medtronic, Inc. (NYSE: MDT) announced the start of PROMISE, a Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain. This is the first-ever, large-scale study comparing the effectiveness of Medtronic neurostimulation therapy with Specify® 5-6-5 multicolumn surgical leads plus optimal medical management (OMM) to the administration of OMM alone in patients with failed back surgery syndrome (FBSS) and predominant low back pain.
"Chronic pain is a clinically challenging and often debilitating condition for which oral medications may provide insufficient relief," said Bart Edmiston, M.D., principal investigator for the PROMISE study at The Neuroscience Center in Ocean Springs, Mississippi, which enrolled the study's first patient on January 8. "The PROMISE study will add to the growing body of evidence supporting Medtronic neurostimulation therapy, a well-established therapeutic approach, for the patients worldwide who continue to experience low back pain following back surgery."
It is estimated that more than 100 million U.S. adults1 and one in five European adults2 live with chronic pain. Back pain is the most prevalent type of chronic pain, affecting approximately 10 percent of the U.S. population alone.3 FBSS is defined as persistent or recurring pain in the back or legs following one or more spine surgeries. The majority of FBSS patients receive physical rehabilitation and/or oral medications to help manage their pain, but studies and clinical experience find that many of these patients will not sufficiently improve and will require additional interventions.4
Medtronic neurostimulation therapy (also known as spinal cord stimulation, or SCS) is a widely established treatment option for chronic back and/or leg pain that has been used to treat more than 250,000 people worldwide. It uses a medical device to deliver mild electrical impulses to the spinal cord to block pain signals from reaching the brain.
PROMISE is a prospective, randomized, open-label, parallel-group, clinical study enrolling up to 300 individuals suffering from predominant chronic low back pain due to FBSS at 30 centers in the United States , Canada and Europe (Belgium, France, Germany, Spain, The Netherlands and The United Kingdom). It is the first large-scale, randomized, controlled clinical trial designed to assess the value of SCS for predominant low back pain with leg pain using a surgical lead, in contrast to previous studies of this technology, which have focused on predominant leg pain.
"Spinal cord stimulation has become an increasingly valued treatment approach in chronic pain, and we look forward to participating in the latest study," said Philippe Rigoard, M.D., the study's global principal investigator, who started enrolling patients January 14 at Poitiers University Hospital in Poitiers, France. "If the PROMISE results are positive, they will provide critically needed relief for those patients suffering from chronic low back pain associated with FBSS."
PROMISE participants will be randomized 1:1 to receive treatment with either SCS with OMM or OMM only. After a six-month observational phase, the study will compare the proportion of participants in the SCS group who report more than 50 percent reduction in low back-pain intensity, as measured by the Numeric Pain Rating Scale, with those in the OMM-only group. Health care utilization data collected will be used to develop cost analysis models for potential use in future studies evaluating the long-term economic impact of SCS.
"Medtronic is committed to advancing the understanding of its neurostimulation therapy in patients with low back pain resulting from FBSS," said Julie Foster, general manager and vice president, Pain Stimulation and Targeted Drug Delivery in the Neuromodulation business of Medtronic, Inc. "PROMISE provides the opportunity to assess not only the degree of pain relief provided by SCS plus OMM compared to OMM alone in failed back surgery patients, but also to evaluate the economic and quality of life impact of this treatment by looking at such important measures as sleep, ability to work and changes in pain medication."
Repros Therapeutics Inc.® (Nasdaq: RPRX) earlier provided a revised date for expected clinical results from the first pivotal study, ZA-301, of Androxal® in the treatment of secondary hypogonadism. The Company now plans to provide the data in Q3 2013 instead of Q2 2013.
During the ongoing review of the data it was determined that one site's patient population was markedly different from the other 16 sites from the standpoint of baseline sperm counts. The site in question had enrolled 40 subjects into the 151 subject trial. Though the subjects at the site meet the strict entry criteria for the trial, the clear difference from the other sites begs the question of whether or not this site represents the general population to be treated or is, in fact, a special population. To that end, the Company felt it would be prudent to remove the site from the efficacy studies and replace the subjects with those enrolled at other sites. Preliminary blinded analysis of reported subjects from the identified site indicates these subjects have responded as well or better than the other sites from the standpoints of improved testosterone and maintenance of sperm concentration.
Fortunately, the Company is enrolling subjects into the identical pivotal trial ZA-302. The current plan, pending regulatory approval, is to move already enrolled subjects from sites in ZA-302 to ZA-301 to make up the shortfall. Since many of these subjects have recently been enrolled, it will extend the time before the data base from the first study can be locked and analyzed. The Company believes it can have the data available for top line release in Q3 of this year.
The Company is attempting to schedule a meeting with the FDA to advise the Agency of Repros' plan. Repros believes this outcome will not affect the timing of the NDA submission currently targeted for mid-2014.
Conference Call Details: Time: Monday, January 28, 2013 – 8AM Eastern Participant Dial In Number: 877-407-0782 International callers: 201-689-8567 Participant Title: Repros Therapeutics Teleconference Replay will be available until February 4, 2013. Replay Number: 877-660-6853, Conference ID#: 408375
Actinium Pharmaceuticals, (OTCBB: CTVN), a biopharmaceutical company that develops innovative targeted payload immunotherapeutics, reported today that the program of the EMIT: Targeted Radiotherapy conference will feature three presentations devoted to Actinium Pharmaceuticals' clinical programs and technology platform.
ALR Technologies (OTCBB: ALRT), a medical device company providing remote monitoring and care facilitation for patients with chronic diseases, today announced that Kent Stoneking, Pharm. D., CDE, has been appointed Director, Diabetes Care Facilitation, effective February 1, 2013.
Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with the neurodegeneration and apoptosis centered around its patented therapeutic protein MANF, today announced the launch of the Company's new website at www.amarantus.com.
Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, announced today that Dr. Steven C. Quay, M.D., Ph.D., FCAP, Chairman, CEO and President, will present the Company's products and services at the 15th Annual BIO CEO and Investor Conference at the Waldorf Astoria Hotel in New York City, on Monday, February 11, 2013, at 1:00 pm Eastern Time (10:00 am Pacific Time).
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) ("Auxilium") and Xstelos Holdings, Inc. (OTCQB: XTLS) ("Xstelos") announced today that they filed a lawsuit against Upsher-Smith Laboratories, Inc. ("USL") for infringement of ten U.S. patents covering Testim, 1% testosterone gel, that are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration ("FDA").
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, will report financial results for the fourth quarter and full year 2012 on Tuesday, February 26, 2013, after the close of the market.
BrainStorm Cell Therapeutics (OTC.QB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that it has appointed Mr. Alon Natanson as its new Chief Executive Officer (CEO).
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced that an in vivo trial investigating aldoxorubicin, its tumor-targeting conjugate of the widely used chemotherapeutic agent doxorubicin, in combination with unconjugated doxorubicin, demonstrated positive results and provided the basis for the Company’s current evaluation of the combination therapy in cancer patients with advanced solid tumors in a Phase 1b clinical trial.
Galectin Therapeutics (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that the American Chemical Society (ACS), as part of its ACS Symposium Series, has published online the proceedings from the galectin-focused symposium hosted by Galectin Therapeutics, Galectins and Disease Implications for Targeted Therapeutics.
Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY), announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental Biologics License Application (sBLA) file seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS).
Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY) and its portfolio companies ProtAb Ltd. ("ProtAb") and KAHR Medical Ltd. ("KAHR") announced today that they will receive additional funding of NIS 10.7 million (over $2.8 million USD) by the Israeli Ministry of Industry and Commerce, Office of the Chief Scientist (OCS) to support product development and advance clinical trials.
Hanover Portfolio Acquisitions (OTCQB: HVPA) will be presenting its investment opportunity to an audience of principals and key decision makers of broker/dealers and financial firms at the FSX Investment Conference to be held in Dallas, Texas from February 7th to 9th, 2013.
IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted an additional abbreviated new drug application (ANDA) to the US FDA, which brings the company’s total number of submissions to nine.
Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) today announced successful top-line results from the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate, for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.
Medicago Inc. (TSX: MDG) (OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced the execution of a collaboration agreement with Mitsubishi Chemical Holdings Corporation ("MCHC") to develop a next generation technology for plant production.
Medicure Inc. (TSX VENTURE:MPH) (PINKSHEETS:MCUJF), a specialty pharmaceutical company, today reported its results from operations for the quarter ended November 30, 2012.
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR") today announced that the Japan Patent Office has allowed Patent Application No. 2008-529977 directed toward a Method and System for Providing Online Medical Records.
Novation Holdings (OTCBB:NOHO) today announced that it has acquired a controlling interest in Alternative Energy Partners, Inc., a mining and energy holding company whose common shares are traded on the OTC BB under the symbol AEGY.
Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) today announced a poster presentation covering positive preliminary results from a Phase I study examining the intravenous administration of REOLYSIN in combination with FOLFIRI in patients with metastatic colorectal cancer (REO 022).
Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced that it is scheduled to ring The NASDAQ Stock Market Opening Bell at 9:30 am EST on Monday, January 28, 2013 to celebrate the Company's listing on the NASDAQ Global Market.
Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) today announced the appointment of Michael Aldridge to the new position of Senior Vice President, Corporate Strategic Development.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced safety findings from the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase (HDAC) inhibitor.
WaferGen Bio-systems, Inc. (OTCBB: WGBS) today announced the results of a successful study of lncRNA markers associated with prostate cancer in the lab of Dr. Arul Chinnaiyan at the University of Michigan Cancer Center.
Waters Corporation (NYSE: WAT) today reinforced its commitment to advancing biotherapeutic characterization technology at the Well Characterized Biotechnology Pharmaceuticals 2013 Symposium (WCBP 2013).
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