|RxNews Recap for Friday 03-05-10. Poniard rises on positive Phase II data. XenoPort restructures.|
|By Mary Davila|
|Friday, 05 March 2010 19:45|
Poniard Pharmaceuticals, Inc. (Nasdaq:PARD), jumped Friday after the company announced the presentation of positive final data, including survival data, from the Company's Phase 2 clinical trial of picoplatin as a first-line therapy in men with metastatic castration-resistant (hormone-refractory) prostate cancer (CRPC). The results were presented in a General Poster Session today at the 2010 American Society of Clinical Oncology's Genitourinary Cancers Symposium in San Francisco, CA.
The final data showed that picoplatin, in combination with docetaxel and prednisone, the current standard of care for CRPC, produced a clinically meaningful benefit in patients as measured by overall survival, progression-free survival (PFS) and prostate specific antigen (PSA) response rate. These results also demonstrated that picoplatin can be safely administered with full doses of docetaxel and prednisone. In addition, no neurotoxicity was observed in these patients. Neutropenia was the most common hematologic adverse event, and was managed with supportive care.
"Safety and efficacy results from this study, particularly the overall survival data, are encouraging and suggest that picoplatin in this combination regimen has the potential to play a meaningful role in the treatment of metastatic prostate cancer," said William K. Oh, M.D., professor of medicine and urology and chief, Division of Hematology and Medical Oncology, Tisch Cancer Institute at Mount Sinai School of Medicine. "The results also support the study of picoplatin as a first-line treatment for advanced prostate cancer, a disease for which too few treatment options currently exist."
Shares of the biopharmaceutical company focused on innovative oncology therapies rose 10 cents or 5.99% to close at $1.77. The stock hit a peak of $2.09 earlier in the session. Volume of 9.1 million shares was more than triple the daily average.
XenoPort, Inc. (Nasdaq:XNPT) announced Friday a restructuring that includes an overall reduction in its workforce of approximately 50%. The restructuring is designed to focus the Company’s resources on advancement of its later-stage product candidates. On February 17, 2010, the U.S. Food and Drug Administration (FDA) issued a Complete Response letter regarding the new drug application for Horizant™ (gabapentin enacarbil) Extended-Release Tablets, an investigational, non-dopaminergic treatment for moderate-to-severe primary restless legs syndrome (RLS).
"The unexpected setback in the approval of Horizant has forced us to conduct a thorough review of our operating plans. We have made the difficult decision to restructure the Company to prioritize later-stage development activity and eliminate our discovery research efforts," said Ronald W. Barrett, Ph.D., XenoPort’s chief executive officer. "We are fortunate to have a number of product candidates in clinical development as well as several other advanced preclinical compounds that can be developed. We believe that maximum value will be created for our stockholders over the next several years by reducing our overall spending while focusing on helping our partners gain approval of Horizant in the U.S. and XP13512 in Japan, completing our ongoing Phase 2b trial of arbaclofen placarbil (AP) in gastroesophageal reflux disease (GERD) patients and initiating a Phase 2 clinical trial of XP21279 in patients with Parkinson’s disease." Shares were off by 45 cents on the day, closing down 5.72%.
Other movers from Friday's market:
Adolor Corporation (NasdaqGM: ADLR) announced Friday that its previously announced presentation at the Cowen and Company 30th Annual Health Care Conference will now occur at 11:05 A.M. Eastern Time on March 9, 2010. Michael R. Dougherty, President and Chief Executive Officer, will present on behalf of the Company. The conference is being held at the Boston Marriott Copley Place, Boston, Massachusetts. Shares of Aldor rose 6.94 % Friday on heavier than normal volume.
Celsion Corporation (Nasdaq:CLSN) leaped Friday by more than 13%. The company announced Monday March 1st that it will initiate a Randomized Phase II Study of Lyso-Thermosensitive Liposomal Doxorubicin (ThermoDox®) and Radiofrequency Ablation (RFA) for Colorectal Liver Metastases (CRLM). Shares closed Fridays session at $4.18, up 13.28% or 49 cents.
Isis Pharmaceuticals, Inc. (Nasdaq:ISIS) announced Friday that it has initiated a Phase 1 study of ISIS-SOD1Rx in patients with an inherited, aggressive form of Lou Gehrig's disease also known as familial amyotrophic lateral sclerosis (ALS). Approximately 20 percent of all familial ALS cases are caused by a mutant form of superoxide dismutase, or SOD1. ISIS-SOD1Rx is an antisense drug designed to inhibit the production of SOD1. The ALS Association and the Muscular Dystrophy Association are providing funding for the development of ISIS-SOD1Rx.
Neurocrine Biosciences, Inc. (Nasdaq:NBIX) announced Friday the pricing of an underwritten public offering of 9,100,000 shares of its common stock at a price to the public of $2.20 per share. The gross proceeds from the sale of the shares, before underwriting discounts and commissions and other offering expenses, are expected to be approximately $20 million. The offering is expected to close on or about March 10, 2010, subject to customary closing conditions. Shares fell 11.54% or 30 cents to close at $2.30.
Pressure BioSciences, Inc. (Nasdaq:PBIO) rose after it announced that a scientific article entitled "Rapid Release of N-Linked Glycans from Glycoproteins by Pressure Cycling Technology" has been published online in the journal, Analytical Chemistry. The article's authors, from the Barnett Institute at Northeastern University (Boston, MA), reported on the ability of PCT to rapidly, effectively, and efficiently release sugar molecules (N-linked glycans) from certain proteins (glycoproteins) that are used in the development of biotherapeutic drugs. Biotherapeutic drugs are viewed by many as the best current hope for the development of more effective treatments for acute, chronic, and life-threatening diseases, such as cancer, arthritis, and diabetes. The majority of these drugs - whether approved, in early development, or in clinical trials, are glycoproteins. In order to ensure quality, efficacy, safety, and biological function, a number of important tests are performed on glycoprotein-based biotherapeutic drugs and drug candidates, at every step of the development and approval process.
"Glycan (carbohydrate) analysis of biotherapeutic drugs provides essential information on quality, efficacy and safety; therefore, the biotech industry places great emphasis on these analyses," commented Professor Barry Karger, Director of the Barnett Institute and one of the authors of the article. "Given the biological and therapeutic significance, rapid, robust, and accurate glycan analysis methods are of high interest." Shares of Pressure BioSciences jumped 7.15% Friday to close at $1.80.
Retractable Technologies, Inc. (AMEX: RVP), a leading maker of safety needle devices, jumped up Friday after announcing that a final judgment and permanent injunction were entered March 4, 2010 in the litigation of Retractable Technologies, Inc. v. OMI (Occupational & Medical Innovations Limited, an Australian company).
On December 18, 2009, the jury delivered a verdict in favor of Retractable in its patent infringement and misappropriation of trade secrets lawsuit against OMI. The Court ordered that Retractable recover damages and prejudgment interest from OMI based on OMI’s misappropriation of trade secrets in the amount of $3,153,575. In addition, the Court entered a permanent injunction enjoining OMI, its manufacturers, distributors and service providers from infringing Retractable’s Patent Number 6,572,584, by making, importing, selling, or using any of OMI’s syringes in the United States and its territories. The permanent injunction was effective at 12:00 noon, Central Time, on March 4, 2010. Shares closed up 5.96% or 9 cents to end the day at $1.60.
REGENERX BIOPHARMACEUTICALS, INC. (NYSE Alternext US:RGN) announced that a research team from the Henry Ford Hospital in Detroit, MI reported that Thymosin beta 4 (T4), administered to rats one day after embolic stroke, improved neurological functional outcome compared to control animals. Improvement in neurological function was measured at various time intervals over a seven week period and was statistically significant.
Stereotaxis, Inc. (Nasdaq:STXS) surged more than 16% Friday on heavier than normal volume. No apparent news could be found for the company which designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. Shares shot up 80 cents to close at $5.68.
YM BioSciences Inc. (NYSE Amex: YMI, TSX:YM), announced that it is raising approximately US$15 million in a "registered direct" offering of units at a price of US$1.20 per unit. Each unit consists of one common share and one half of one common share purchase warrant. Each whole warrant entitles the holder to acquire one common share at a price of US$1.60 commencing six months from closing for a period of five years from closing. Roth Capital Partners, LLC, served as lead placement agent. Bloom Burton & Co. Inc., Griffin Securities, Inc. and Haywood Securities Inc. served as co-placement agents for the transaction. The funds will be used principally to fund YM's drug development activities and for general corporate purposes. Shares of YM dropped 17.99% or 25 cents to close the day at $1.14.
More news from Friday:
Biogen Idec Inc. (NASDAQ: BIIB) announced today that its presentation at the Cowen and Company 30th Annual Health Care Conference will be webcast live, via the internet, on Wednesday, March 10, 2010 at 8:00 a.m. EST.