CRME Opens Wallet, CGIX Launches FHACT, ENTA's SAPPHIRE Sparkles, IPCI Explodes

(RTTNews) - Actinium Pharmaceuticals Inc. (ATNM.OB) said that only a single pivotal phase III clinical study will be required for regulatory approval of its clinical stage bone marrow transplants product Iomab-B in refractory Acute Myeloid Leukemia patients.

The company noted that its second product candidate Actimab-A is continuing its clinical development in a phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single arm multicenter trial. Interim results from the trial are expected in 2014.

ATNM.OB closed Monday's trading 2.54% higher at $6.46.

Auxilium Pharmaceuticals, Inc. (AUXL) said it intends to submit supplemental Biologics License Application for XIAFLEX to the FDA, seeking expansion of the labeling for the concurrent treatment of multiple palpable cords in the first quarter of 2014.

XIAFLEX is approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren's contracture patients with a palpable cord. A supplemental Biologics License Application for XIAFLEX for the treatment of Peyronie's disease is under FDA review with a decision date set for December 6, 2013.

AUXL closed Monday's trading at $19.07, down 1.95%.

Cancer Genetics Inc.'s (CGIX) proprietary DNA-based test for cervical cancer has received regulatory approval from the Clinical Laboratory Improvement Amendments as a Laboratory Developed Test.

The test, known as FHACT, is focused on earlier detection and enables genomic guided decision making and triaging of cervical cancer caused by HPV.

Cardiome Pharma Corp. (CRME) (COM.TO) has acquired Correvio LLC, a privately held, Switzerland-based pharmaceutical company that specializes in critical care with an understanding of interventional cardiology.

The transaction is expected to be accretive immediately and accelerate Cardiome's launch of BRINAVESS and its transformation into a global commercial organization positioned for future growth.

CRME closed Monday's trading 3.35% higher at $4.01.

Enanta Pharmaceuticals Inc. (ENTA) said that results from SAPPHIRE-I study, one of six phase III registrational studies, demonstrated a sustained virologic response at 12 weeks post-treatment (SVR12) of 96 percent in treatment-naïve adult patients chronically infected with GT1 HCV.

SAPPHIRE-I evaluated the efficacy and safety of 12 weeks of treatment with ABT-333 (250mg), ribavirin (weight-based), both dosed twice daily, and the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg) and dosed once daily in non-cirrhotic, GT1a and GT1b HCV-infected, treatment-naïve adult patients.

ENTA closed Monday's trading 3.70% higher at $21.

Intellipharmaceutics International Inc. (IPCI) (I.TO) has been granted FDA approval for its generic version of Focalin XR of 15 and 30 mg strengths. Focalin XR, marketed by Novartis Pharmaceuticals Corp., is indicated for attention deficit hyperactivity disorder.

Intellipharmaceutics is partnered with Par Pharmaceutical Inc. for the commercialization of generic Focalin XR. As the first-filer for the drug product in the 15 mg strength, Intellipharmaceutics will have 180 days of exclusivity of generic sales from the date of launch in the United States by its partner, Par.

The company's ANDAs for generic Focalin XR of 5, 10, 20 and 40 mg strengths have also been tentatively approved by the FDA.

IPCI closed Monday's trading 2.72% higher at $1.89. In after-hours, the stock was up 64% to $3.01.

Mesoblast Ltd.'s (MBLTY.OB) proprietary mesenchymal precursor cells have been found to strengthen native heart function when injected directly into the heart muscle of end-stage heart failure patients receiving a surgically implanted left ventricular assist device (LVAD) heart pump to maintain circulation in a phase II trial.

Recently, the FDA cleared commencement of a phase III trial of mesenchymal precursor cells in patients with New York Heart Association class II or III chronic congestive heart failure after filing of an Investigational New Drug application by Mesoblast's development and commercialization partner Teva Pharmaceutical Industries Ltd.

OXiGENE Inc.'s (OXGN) novel anticancer compounds, Benzosuberenes, demonstrated potent anti-proliferative activity in preclinical studies, according to data presented at the Southwest Regional Meeting (SWRM) of the American Chemical Society.

The Benzosuberene compounds are the product of OXiGENE's ongoing collaboration with Kevin G. Pinney, Ph.D. and Mary Lynn Trawick, Ph.D. at Baylor University to identify inhibitors of tubulin polymerization as vascular disrupting agents (VDAs).

OXiGENE has an exclusive license to the worldwide rights to all of the compounds that result from the collaboration.

OXGN closed Monday's trading at $2.95, down 5.45%. In extended trading, the stock was up 6.44% to $3.14.

Prana Biotechnology (PRAN) said that it expects results of its phase II clinical trial evaluating of PBT2 in Alzheimer's patients, dubbed IMAGINE, to be reported in March 2014.

According to the company, 29 patients of the 42 patients originally enrolled into the trial have now completed treatment.

PRAN closed Monday's trading at $4.93, down 8.87%.