XenoPort Reports Favorable Metabolism and Pharmacokinetics of XP23829, a Novel Fumaric Acid Ester, in Phase 1 Trial

Intends to Advance Development for Potential RRMS and/or Psoriasis Treatment

XenoPort, Inc. (XNPT) announced today favorable preliminary results from a Phase 1 clinical trial in healthy adults designed to assess the pharmacokinetics (PK), safety and tolerability of single doses of four different oral formulations of XP23829, a novel fumaric acid ester compound that is a prodrug of monomethyl fumarate (MMF). XP23829 is being developed for the potential treatment of relapsing-remitting multiple sclerosis (RRMS) and/or psoriasis. The trial demonstrated that administration of XP23829 resulted in the expected levels of MMF in the blood. As anticipated, the four formulations produced different PK profiles of MMF, including one formulation that could potentially be dosed two or three times a day and at least one formulation that may be suitable for once-a-day dosing. XP23829 was generally well-tolerated in the trial.

Published: 05 October 2012
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PROLOR Biotech Receives Notice of Allowance for New U.S. Patent for Its Long-Acting Human Growth Hormone

PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent application covering the company's long-acting CTP-enhanced human growth hormone (hGH-CTP).  Upon issuance, the new patent would provide PROLOR with additional intellectual property protection covering methods for the induction of growth in growth hormone deficient patients. 

This new patent is the fourth hGH-CTP patent that has been allowed by the USPTO. The expanding hGH-CTP patent estate is expected to provide additional protection for PROLOR's hGH-CTP compound, in addition to a number of CTP platform patents that have already issued.

Published: 03 October 2012
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Sarepta Therapeutics Announces Eteplirsen Meets Primary Endpoint of Increased Novel Dystrophin and Achieves Significant Clinical Benefit on 6-Minute Walk Test After 48 Weeks of Treatment in Phase IIb Study in Duchenne Muscular Dystrophy

Eteplirsen Results in an Increase in Novel Dystrophin to 47% of Normal After 48 Weeks of Treatment; Eteplirsen 50mg/kg Weekly Demonstrates Continued Clinical Benefit of 89.4 Meters in 6-Minute Walk Test Over Placebo/Delayed Treatment Cohort; No Eteplirsen-Related Adverse Events Through Week 48

Sarepta Therapeutics ( NASDAQ : SRPT ), a developer of innovative RNA-based therapeutics, today announced that treatment with its lead exon-skipping compound, eteplirsen, met the primary efficacy endpoint, increase in novel dystrophin, and achieved a significant clinical benefit on the primary clinical outcome, the 6-minute walk test (6MWT) over the placebo/delayed treatment cohort in a Phase IIb extension trial in Duchenne muscular dystrophy (DMD) patients. 

Published: 03 October 2012
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Cell Therapeutics OPAXIOTM Receives Orphan Drug Designation for Malignant Brain Cancer from FDA

Randomized front line trial utilizing tumor genomic profiling tests OPAXIO plus radiation therapy compared to current standard of care of radiation with temozolamide in high risk patients with glioblastoma multiforme

Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced that OPAXIO (paclitaxel poliglumex) has been granted orphan-drug designation by the U.S Food and Drug Administration ("FDA") for the treatment of glioblastoma multiforme ("GBM"), a malignant brain cancer.

Published: 02 October 2012
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Updated Results from Phase 2b/3 GALAXY Trial Show Promising Improvement in Survival from the Addition of Ganetespib to Docetaxel in Second-Line Non-Small Cell Lung Cancer

– Data presented at ESMO 2012 Congress –
– Results support advancing to Phase 3 stage of GALAXY trial –
– Ganetespib shown to have potent anti-angiogenic properties –
– Synta hosts reception to discuss results, webcast replay available at www.syntapharma.com

Synta Pharmaceuticals Corp. (SNTA) today announced results from an interim analysis of the Phase 2b portion of the GALAXY trial, a global, randomized, multi-center Phase 2b/3 study designed to evaluate the efficacy and safety of the Company’s lead Hsp90 inhibitor, ganetespib, as second-line treatment for advanced non-small cell lung cancer (NSCLC).

Published: 01 October 2012
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