|Rexahn Reports Positive Phase 2 Data for Archexin; Dynavax Announces FDA Advisory Committee to Review HEPLISAV|
|By Staff and Wire Reports|
|Tuesday, 28 August 2012 18:08|
Rexahn Pharmaceuticals, Inc. (NYSE: RNN), a clinical stage biopharmaceutical company focused on developing multi-indication therapeutics in oncology and CNS, announced top-line results from a Phase II clinical study of Archexin®, its clinical-stage oncology drug candidate. Archexin is being developed as a potential first-in-class inhibitor of the Akt protein kinase (Akt) in cancer cells.
The open label 2-stage study was designed to assess the safety and efficacy of Archexin in combination with gemcitabine. Stage 1 was the dose finding portion and stage 2 was the dose expansion portion using the dose identified in stage 1 to be administered with gemcitabine. The study enrolled 31 subjects aged 18-65 years with metastatic pancreatic cancer at four centers in the United States and five centers in India. The primary endpoint was overall survival following 4 cycles of therapy with a 6-month follow-up.
Dynavax Technologies Corporation (NASDAQ: DVAX) announced the U.S. FDA has informed the Company that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to discuss HEPLISAV at its meeting on November 14-15, 2012.
Dynavax's Biologic License Application (BLA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age, is currently under review by the FDA. The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review is February 24, 2013.
AdCare Health Systems, Inc. (NYSE MKT: ADK), a leading long-term care provider, has been invited to present at the 2012 Gateway Conference being held on September 6 at the W San Francisco Hotel.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that a first patient has been recruited for a Phase 2A trial with its ghrelin agonist, AEZS-130 in patients with cancer cachexia.
ALR Technologies Inc. (OTCBB: ALRT) (the "Company"), a health information technology developer, has completed development of its HIPAA-compliant, FDA-cleared Internet-based glucose monitoring system, Health-e-Connect.
AmbiCom Holdings, Inc. (OTCBB: ABHI), announced that they expect to ship more than $1.5 million worth of orders to two long-term customers in the healthcare and automotive fields from September to December.
Bacterin International Holdings, Inc. (NYSE Amex: BONE), a leader in the development of unique bone graft material and antimicrobial coatings for medical applications, announced the closing of a $25 million non-dilutive financing with an affiliate of OrbiMed Advisors LLC.
BIOLASE, Inc. (NASDAQ: BIOL), the World's leading dental laser manufacturer and distributor, today announced that its Board of Directors has declared a one-half percent stock dividend payable on September 28, 2012, to stockholders of record on September 14, 2012.
Biostem U.S., Corporation (OTCQB: HAIR) (PINKSHEETS: HAIR) (Biostem, The Company), a fully reporting public company in the stem cell regenerative medicine sector, announced today that, in response to overwhelming inquiries from hair clinics around the nation, it has completed preparation to allow for expansion of hair regrowth services throughout the United States.
Forest Laboratories, Inc. (NYSE: FRX) (“Forest”) today commented on the Delaware Court of Chancery’s decision to deny Carl Icahn’s demands for access to certain books and records of the Company.
Noble Financial Capital Markets (Noble) announced today that Australian company, Mesoblast (ASX: MSB) (PINKSHEETS: MBLTY) will be among the 30 life sciences companies to attend BIOX, an investor exposition to be held at the University of Connecticut in Stamford, CT on September 24-25, 2012.
Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it has received notice from the Canadian Intellectual Property Office that it has obtained patent issuance for its proprietary GMP formulation for Soluble Ferric Pyrophosphate (SFP), the Company's lead investigational drug that provides iron replacement to hemodialysis patients with CKD.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals (NASDAQ:PGNX) today received at approximately 5:00 p.m. ET a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following its review of a Supplemental New Drug Application (sNDA) for RELISTOR ® (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.
Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative diagnostic testing and genetic analysis solutions, today announced that its wholly-owned subsidiary, the Sequenom Center for Molecular Medicine (Sequenom CMM), has completed several international distribution agreements that will expand access to the MaterniT21 PLUS testing service outside the United States.
TNI BioTech, Inc. (PINKSHEETS: TNIB) announced that it acquired exclusive licensing rights to all of the proprietary technical information, know-how, procedures, IND, protocols, methods, prototypes, designs, data and reports, which are not readily available to others through public means, and which are owned, generated or developed through experiments or testing by Dr. Bernard Bihari.
Transgenomic, Inc. (OTC/BB: TBIO) and the Medical College of Wisconsin (MCW) today announced a collaboration agreement under which Transgenomic will offer next-generation genetic testing services performed at the MCW Clinical Sequencing Program.
UnitedHealth Group (NYSE: UNH) and its benefits and services businesses, UnitedHealthcare and Optum, are taking action to help people in Louisiana, Mississippi and Alabama prepare for any potential disruption that may be caused by Tropical Storm Isaac.
Vermillion, Inc. (NASDAQ: VRML), a leading molecular diagnostics company, has been invited to present at the 2012 Gateway Conference being held on September 6 at the W San Francisco Hotel.
XenoPort, Inc. (Nasdaq:XNPT) announced today the pricing of an underwritten offering of 6,153,846 shares of its common stock at a price to the public of $6.50 per share.