LX4211 Achieves Positive Results in Type 2 Diabetes Patients with Renal Impairment

 Lexicon Pharmaceuticals, Inc. (LXRX) announced today that LX4211, a first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), successfully met the primary endpoint of reducing post-prandial glucose, in a study of patients with type 2 diabetes and moderate to severe renal impairment.  Reducing elevated post-prandial glucose, high blood sugar levels after meals, is a key objective of diabetes therapy.

In a placebo-controlled, proof-of-concept study, LX4211 provided clinically meaningful and statistically significant reductions (p2. LX4211 also produced significant elevations in GLP-1, a hormone involved in control of glucose and appetite.

Published: 01 October 2013
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GenVec Announces Dismissal Of Class Action Lawsuit

GenVec, Inc. (GNVC) today announced that the previously disclosed putative class action lawsuit filed against the Company and certain of its current and former officers (the "Defendants") by the law firm of Brower Piven in the United States District Court for the District of Maryland has been dismissed with prejudice. No payment was made by any of the Defendants to the plaintiffs or their counsel in connection with the lawsuit. The Company does not know whether the plaintiffs will file a Notice of Appeal.

"There are no winners when an experimental therapeutic fails in clinical trials, especially for a challenging and underserved indication such as pancreatic cancer.  We are extremely pleased, however, that the Court recognized that the plaintiffs' claims were without merit and granted in full and with prejudice our motion to dismiss," commented Douglas J. Swirsky, President and Chief Executive Officer of GenVec. 

Published: 24 September 2013
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Cyclacel's Sapacitabine Reported to Have Anti-Tumor Activity Against Ovarian Cancer

75% of Ovarian Cancer Patient Samples Highly Sensitive to Sapacitabine Including Those Resistant to Therapy

Cyclacel Pharmaceuticals, Inc. (CYCC) (CYCCP) ("Cyclacel" or the "Company") today announced updated data showing that sapacitabine has activity against a majority of ovarian cancer samples taken from patients, including resistant tumors. The data were reported at a poster presentation during the American Association of Cancer Research (AACR) conference "Advances in Ovarian Cancer: from concept to clinic" being held September 18-21, 2013, in Miami, FL.

Published: 20 September 2013
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Regado Biosciences, Inc. Enrolls First Patient in Phase 3 Trial of REG1

"REGULATE-PCI" to Study REG1 in Patients Undergoing Percutaneous Coronary Intervention

Regado Biosciences, Inc. (RGDO), a biopharmaceutical company focused on the discovery and development of novel, first-in-class, actively controllable antithrombotic drug systems for acute and sub-acute cardiovascular indications, today announced the enrollment of the first patient in its REGULATE-PCI clinical trial.  REGULATE-PCI is a Phase 3, PROBE design (Prospective, Randomized, Open-label, Blinded-Endpoint) superiority study comparing the effects of Regado's REG1 to bivalirudin in patients undergoing percutaneous coronary intervention (PCI) electively or for the treatment of unstable angina (UA) or non-ST elevated myocardial infarction (N-STEMI).  REGULATE-PCI, if successful, will serve as the basis for product registration applications throughout the world.

Published: 17 September 2013
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KYTHERA Announces Positive ATX-101 Top Line Phase III Trial Results for the Reduction of Submental Fat

REFINE-1 and REFINE-2 Trials Demonstrate Statistically Significant Results for Primary and Secondary Endpoints

KYTHERA Biopharmaceuticals, Inc. (KYTH) today announced that its ATX-101 REFINE-1 and REFINE-2 Phase III trials met all primary and secondary endpoints. These two pivotal Phase III trials were conducted in the U.S. and Canada to compare the efficacy and safety of a 2 mg/cm2 dose of ATX-101 versus placebo for the reduction of submental fat, which commonly presents as a double chin. ATX-101 is a proprietary formulation of a purified synthetic version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat.1 If approved, it will be a first-in-class submental contouring injectable drug.

Published: 17 September 2013
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