|Positive data sends Apricus Biosciences shares higher. FONAR soars on earnings increase|
|By BioMedReports.com Staff|
|Friday, 19 November 2010 19:24|
After the bell Friday Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) announced that it will hold a teleconference and webcast at 8:30 a.m. Eastern Time on Monday, November 22, to discuss results of two Phase 3 studies with VEGF Trap-Eye in Wet Age-related Macular Degeneration, VIEW 1 and VIEW 2, and its VEGF Trap-Eye program. A press release will be issued on Monday prior to the call.
After the market close, Helix BioPharma Corp. (TSX:HBP) (AMEX:HBP) (Frankfurt:HBP), a biopharmaceutical company developing drug candidates for the prevention and treatment of cancer, today announced that it has received verbal notice from the United States Food and Drug Administration that its pending Topical Interferon Alpha-2b Phase II/III investigational new drug application has been placed on "clinical hold".
An IND application "clinical hold" is an order that the FDA issues to a clinical trial sponsor to postpone approval to conduct a proposed trial pending resolution of issues raised during IND application review.
The "clinical hold" was issued only because the FDA requires additional product analytical information and not because of any problems relating to the planned Phase II/III trial design or Helix's clinical/preclinical findings to-date.
"We welcome the FDA's comments which will further aid us in preparing our Topical Interferon Alpha-2b product to meet commercial standards of biopharmaceutical analytical characterization, and thereby facilitate the market authorization process assuming successful completion of Helix's planned pivotal trials," said John Docherty, president of Helix BioPharma Corp.
Pre-clinical data gave shares of Apricus Biosciences, Inc., (Nasdaq:APRI) a boost today. The company announced data from animal studies showing that the NexACT technology significantly improved the oral delivery of five small molecule drugs tested, with the best improvements up to 20-fold, in terms of improvement in absorption. A total of 10 small molecule therapeutic drugs with known low solubility and/or permeability, according to the Biopharmaceuticals ("BCS") Classification System, were selected for these studies, and represented the following classes: anti-inflammatory drugs, diuretics, anti-hypertensives, antibiotics, anti-psychotics, anti-Parkinson agents and proton pump inhibitors.
Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "Drugs are classified according to their solubility and permeability. This early data shows that the inclusion of NexACT can significantly improve the oral delivery of some small molecules by positively affecting their solubility, which affects absorption. Over time, this could open up exciting new partnership opportunities, especially for promising drug candidates that did not reach, or successfully pass through clinical development, because of poor solubility. Our goal is to make a major breakthrough in the utilization of NexACT to improve and/or enable the delivery of difficult-to-absorb compounds."
Shares of Apricus soared 23% or 50 cents to $2.70. In extended trading shares continued up another 7 cents.
FONAR Corporation (NASDAQ:FONR), The Inventor of MR Scanning, today announced its earnings for the first quarter of fiscal 2011, ending September 30, 2010.
Income from operations for the quarter ending September 30, 2010 was $435,000 as compared to a loss of $1,422,000 for the same period one year earlier, ending September 30, 2009. FONAR has had income from operations for three quarters in a row.
Net income for the first quarter of fiscal 2011 ending September 30, 2010 was $385,000 as compared to a net loss of $1.7 million for the same quarter one year earlier ending September 30, 2009.
Total product sales for FONAR UPRIGHT Multi-Position MRI scanners increased 70% from $1.6 million for the three-month period ending September 30, 2009, to $2.7 million for the three-month period ending September 30, 2010.
Worldwide 147 FONAR UPRIGHT Multi-Position MRI units have been installed as of September 30, 2010.
On volume of 3.4 million shares of Fonar surged 62 cents or 60.78% to $1.64. Shares in extended trading hit $2.29 before falling back and settling at $1.76.
AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced preclinical data from AVEO’s anti-RON antibody program which demonstrated the successful identification of antibodies with potent anti-tumor activity that demonstrated inhibition of the function of both wild type RON and the RON160 variant, as well as a potential biomarker to identify tumors likely to respond to treatment with the anti-RON antibody.
Boston Scientific Corporation (NYSE:BSX) today announced the signing of a definitive merger agreement, under which Boston Scientific will acquire Sadra Medical, Inc., a development-stage company in Los Gatos, California. Sadra is developing the first fully repositionable device for percutaneous aortic valve replacement to treat patients with severe aortic stenosis. The agreement calls for an upfront payment of $225 million plus additional potential payments of up to $225 million upon achievement of specified regulatory and revenue-based milestones through 2016. As a result of the Company's existing 14 percent ownership of Sadra, the actual upfront cash payment by the Company will be $193 million plus additional potential milestone payments up to $193 million.
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, announced today that updated Phase 2 clinical trial results of sapacitabine for the treatment of myelodysplastic syndromes (MDS) will be presented at a poster presentation during the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, on Saturday, December 4, 2010.
ImmunoGen, Inc (Nasdaq:IMGN), a biotechnology company that develops antibody-based anticancer products using its Targeted Antibody Payload (TAP) technology, today announced the presentation of encouraging clinical data for the Company’s IMGN388 anticancer compound at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics taking place in Berlin, Germany.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it presented updated safety and clinical activity data from the FALCON trial, a randomized, controlled Phase 2 study of ZYBRESTAT(TM) (CA4P) in patients with non-small cell lung cancer (NSCLC). The updated analysis showed that the median time to progression for patients receiving ZYBRESTAT plus bevacizumab and chemotherapy was 9.5 months, compared with a median time to progression of 8.8 months for patients receiving bevacizumab and chemotherapy alone. Of the patients in the study arm (ZYBRESTAT combined with bevacizumab and carboplatin/paclitaxel chemotherapy), 50% achieved a partial response, compared with the control arm (bevacizumab and chemotherapy) of the trial, where only 38% of patients achieved a partial response. The combination regimen including ZYBRESTAT was observed to be well-tolerated with no significant cumulative toxicities when compared with the control arm of the study.
Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX) today announced that it has priced an underwritten public offering of 8,800,000 shares of its common stock at a price to the public of $2.95 per share. The offering is expected to close on or about November 24, 2010, subject to customary closing conditions. Shares fell 42 cents to $2.96.
Also Friday:EPIC Corporation (PINKSHEETS: EPOR) a financial services company, and its subsidiary, RX Healthcare Systems, Ltd., a healthcare products and services company, are now selling the SOMNUS Sleep Pad™.
Masimo (Nasdaq:MASI) today announced that its management is scheduled to present at the Piper Jaffray 22nd Annual Healthcare Conference at The New York Palace in New York City on Tuesday, November 30, at 12:30 p.m. ET.
Pfizer Inc. (NYSE:PFE) announced today that the Phase 3 AXIS 1032 trial (A4061032), studying the investigational compound axitinib in previously treated patients with metastatic renal cell carcinoma (mRCC), has met its primary endpoint, demonstrating that axitinib significantly extended progression-free survival (PFS) when compared to sorafenib, in the study population.