|CytRx Wins Recommendation to Complete Phase 2b Trial with Tamibarotene; Pfizer Wins Patent Case Against Watson|
|By Staff and Wire Reports|
|Thursday, 31 January 2013 19:27|
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced Data Safety Monitoring Committee overseeing the Company's global Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents as a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC) has recommended conducting the clinical trial through completion. Enrollment of at least 140 evaluable patients is expected in the first quarter of 2013.
“The Committee's recommendation indicates that no significant safety issues have been seen with tamibarotene in the international Phase 2b clinical trial as we near enrollment completion with tamibarotene's use in combination with potent chemotherapy agents in patients with advanced NSCLC,” said CytRx CEO Steven A. Kriegsman. “We are one step closer to completing this important clinical trial and further assessing tamibarotene in a potential multibillion dollar market, which is a major priority for our Company and our shareholders.”
Subjects with stage IIIb or IV NSCLS who have not received prior non-adjuvant chemotherapy are being enrolled in the blinded, randomized clinical trial at sites in the U.S., Bulgaria, India, Mexico, Russia and Ukraine. Trial patients are treated with paclitaxel plus carboplatin and either tamibarotene or placebo. The primary objective of this trial is to determine the objective response rate (complete and partial responses) and progression-free survival. Secondarily, the trial will evaluate overall survival and quality-of-life in this population, among other measures. The Data Safety Monitoring Committee is an independent group of oncologists and biostatisticians who monitor the safety and efficacy of the Phase 2b trial.
Pfizer Inc. (NYSE: PFE) said the United States District Court for the District of Delaware ruled that Pfizer's patent covering a method for using sirolimus, the active ingredient in RAPAMUNE®, for the inhibition of organ transplant rejection is valid and infringed. The company brought a patent infringement action in April 2010 against the generic company Watson Laboratories, Inc—Florida (now known as Actavis) and three other Watson entities after Watson applied to the FDA to market a generic version of RAPAMUNE®. The Court's decision prevents Watson from marketing its generic version of RAPAMUNE® in the U.S. before Pfizer's patent expires, pending a possible appeal by Watson.
The patent at issue in the lawsuit is U.S. Patent No. 5,100,899, which including pediatric exclusivity, expires January 7, 2014. In response to the decision, Amy Schulman, Executive Vice President and General Counsel for Pfizer, said, “We are pleased with the Court's decision, recognizing the validity of our patent."
In the United States, RAPAMUNE® is indicated for the prevention of organ transplant rejection in kidney transplant patients aged 13 years and older.
ActiveCare, Inc. (OTCBB: ACAR), the service leader in disease and diabetes management today reported through its contract with Colorado Choice Health Plans and TPA that ActiveCare will not only be monitoring diabetics, but hypertension and congestive heart failure members.
Allergan, Inc. (NYSE: AGN) (“Allergan”) today announced that its wholly-owned subsidiary, Groundhog Acquisition, Inc. (“Purchaser”), has commenced a tender offer to purchase all outstanding shares of common stock of MAP Pharmaceuticals, Inc. (NASDAQ: MAPP) (“MAP”) for $25.00 per share, net to the seller in cash, without interest and less any applicable withholding taxes.
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 it has secured an additional $1.4 million of financing commitments through an amendment of the initial Convertible Note with Dominion Capital.
Amgen (NASDAQ: AMGN) today announced that it will hold its Business Review Meeting on Thursday, Feb. 7, 2013, at the Mandarin Oriental Hotel, 80 Columbus Circle, New York City, beginning at 8 a.m. Eastern Standard Time.
CEL-SCI Corporation (NYSE MKT: CVM) announced that its longstanding collaboration with Northeast Ohio Medical University has produced a new investigational breast cancer vaccine which prevents and treats a HER-2/neu expressing breast cancer tumor in a mouse model of the disease.
Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that ThermoDox® in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase III HEAT Study in patients with hepatocellular carcinoma (HCC), also known as primary liver cancer.
Crown Marketing Pharmaceuticals (OTC: CWNM) announced today that it has achieved positive in-vitro testing results of the most widely prescribed Diabetes drug commonly known as Metformin.
CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced today that 2012 fourth quarter and year end financial results will be released on Thursday, February 14, 2013.
Daxor Corporation (NYSE MKT: DXR), Christiana Medical Center, the largest hospital in Delaware, presented a study on the diagnosis of hyponatremia in critically ill neurologic patients.
Daiichi Sankyo Company, Limited (TSE 4568) and ArQule, Inc. (Nasdaq: ARQL) today announced that the first patient has been enrolled in the pivotal Phase 3 METIV-HCC (MET-high patients with tivantinib in HCC) trial of tivantinib (ARQ 197).
eHealth, Inc. (NASDAQ: EHTH), America's first and largest private health insurance exchange, announced today that the company plans to release fourth quarter and fiscal year 2012 financial results on February 14, 2013.
Foster Wheeler AG (Nasdaq: FWLT) plans to hold a conference call on Friday, March 1, at 2:00 p.m. Central European Time (8:00 a.m. Eastern Time in the U.S.) to discuss its financial results for the fourth quarter and fiscal year ended December 31, 2012.
Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that it submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) on January 30, 2013.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from Stage 1 of CLL11, a Phase III randomized study to investigate the efficacy and safety profile of the investigational medicine obinutuzumab (GA101) plus chlorambucil chemotherapy compared with chlorambucil alone in people with previously untreated chronic lymphocytic leukemia (CLL).
Generex Biotechnology Corporation (OTCBB: GNBT), (www.generex.com), today explained the potential of the technology platform used as the basis for its novel breast cancer immunotherapy product AE37.
La Jolla Pharmaceutical Company (OTCQB: LJPC) ("La Jolla" and "Company"), a leader in the development of therapeutics that target galectin-3, announced that George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer presented today at the 2013 Orlando World MoneyShow at the Gaylord Palms Resort and Convention Center in Kissimmee Florida.
Luminex Corporation (NASDAQ: LMNX) today announced that management will present at the Leerink Swann Global Healthcare Conference to be held February 13 -14, 2013, in New York, NY.
Neptune Technologies & Bioressources Inc. (NASDAQ:NEPT) (NTB.TO) the pioneer in the krill oil industry, recently announced the filing of a complaint in the United States International Trade Commission (the "ITC") against multiple infringers, including Aker BioMarine ("Aker"), for infringement of U.S. Patent No. 8,278,351, which contains composition of matter claims.
Novelos Therapeutics, Inc. (OTCQX: NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that an oral presentation on research conducted by Novelos and its collaborators is being made by Dr. Christopher Pazoles at the EMIT: Targeted Radiotherapy international conference taking place January 29 to 31, in Washington, D.C.
OPKO Health, Inc. (NYSE: OPK) today announced the closing of its offering of $175.0 million aggregate principal amount of 3.00% convertible senior notes due 2033 (the “Notes”) in a private offering.
Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cellular-based virology assays, will release fourth quarter and full year 2012 financial results after market close on Tuesday, February 12, 2013.
Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today the appointment of Mark G. Foletta to its Board of Directors and Audit Committee, effective immediately.
RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a leading provider of orthopedic and other biologic implants, announced today that it plans to release financial results from the fourth quarter and year end 2012 on Thursday, Feb. 7, 2013 prior to the market open.
Star Scientific, Inc. (NASDAQ: STSI) today announces publication of the first peer-reviewed article examining the effects of anatabine in a mouse model of the debilitating autoimmune and neurodegenerative disease multiple sclerosis (MS).
Immediately after Tekmira (NASDAQ: TKMR) (TSX: TKM) announced that it had settled litigation between it and Alnylam Pharmaceuticals, Byron Capital analyst Douglas Loe maintained his SPECULATIVE BUY rating on the company, but raised his price target on shares a full $5 to $12.50.
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) today announced top-line results of the Phase IIb/III clinical study (MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and safety of tasimelteon as a monotherapy in the treatment of patients with MDD.
VG Life Sciences (OTC Pink: VGLS) reports details of the successful completion of the first stage of its Phase I Trial to treat ovarian cancer.
VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) announced today that it has submitted to the U.S. Food and Drug Administration (FDA), for 510(k) clearance, the first 2D-ultrasound right-heart analysis system in patients with Pulmonary Arterial Hypertension (PAH).