Cortex Receives Patent For Ampakine Molecules. Peregrine Reports Promising Median Overall Survival Advanced Breast Cancer Trial. Print E-mail
By Staff and Wire Reports   
Wednesday, 24 August 2011 18:51
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 24, 2011.

Cortex Pharmaceuticals, Inc.  (OTC:CORX) announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent that protects the use of AMPAKINE® molecules for the treatment or prevention of respiratory depression. This patent broadly covers all AMPAKINE molecules, including competitor compounds, and provides patent protection into 2027. The patent is licensed exclusively to Cortex from the University of Alberta, and is based on the pioneering research of Dr John Greer.

AMPAKINE compounds have previously demonstrated proof-of-concept in the prevention of opiate-induced respiratory depression in both animal models and in a human clinical study. In these double-blind, placebo-controlled, cross-over clinical trials, baseline breathing rates were significantly depressed by the potent opiate, alfentanil. A single oral dose of the AMPAKINE, CX717 prevented alfentanil-induced respiratory depression without interfering with the desired analgesic effects of the opiate.

Earlier this year, Cortex reported results from a Phase IIa sleep lab study with its lead AMPAKINE molecule, CX1739 in subjects with moderate to severe sleep apnea. The results from this study suggested a potential opportunity for CX1739 in the treatment of central sleep apnea, which is often seen in heart failure patients and chronic opiate users. This same brain region, the respiratory rhythm generator, also plays a role in central sleep apnea, a form of central respiratory depression which occurs during sleep in approximately 30-40% of heart failure patients.

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Peregrine Pharmaceuticals Inc., (NASDAQ:PPHM), announced 20.7 month median overall survival (OS) from a prior single-arm Phase II trial evaluating bavituximab in combination with docetaxel in patients with locally advanced or metastatic breast cancer. In a separate published study(1) included in the docetaxel package insert, median OS was 11.7 months for metastatic breast cancer patients treated with docetaxel alone.

Currently, Peregrine's bavituximab is being evaluated in randomized Phase II trials in non-small cell lung cancer (NSCLC), pancreatic cancer, and hepatitis C virus (HCV), as well as in four investigator-sponsored trials (ISTs) in additional oncology indications, including HER2-negative metastatic breast cancer.

In Peregrine's prior single-arm, multi-center Phase II trial, 46 patients with locally advanced or metastatic breast cancer who had received one prior chemotherapy regimen were treated with weekly bavituximab and docetaxel. The primary endpoint, objective response rate (ORR), was 61%, with 11% of the patients achieving a clinical complete response in accordance with RECIST criteria, compared to ORR of 41% of patients in a separate trial used as a historical control using weekly docetaxel alone. Neither of these earlier studies selected patients based on hormone receptor status.


Also Wednesday:


AtheroNova Inc. (OTCBB: AHRO) ("AtheroNova"), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque, will be a presenting company at the Rodman & Renshaw 13th Annual Healthcare and Global Investment Conference to be held in New York City from September 11-13, 2011 at the Waldorf-Astoria.

Bacterin International Holdings, Inc. (NYSE Amex:BONE), a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, has been invited to present at the Stifel Nicolaus 2011 Healthcare Conference.

Codexis, Inc. (Nasdaq:CDXS) presented important technical progress in its carbon capture program yesterday at the CO2 Capture Technology Meeting being sponsored this week by the U.S. Department of Energy/National Energy Technology Laboratory in Pittsburgh.

PAREXEL International Corporation (NASDAQ:PRXL), a leading global biopharmaceutical services provider, today announced that the Company has been included on the "Best 5–Pharmaceutical" industry sublist as part of The International Association of Outsourcing Professionals® (IAOP®) annual ranking The Global Outsourcing 100.

Questcor Pharmaceuticals, Inc. (NASDAQ:QCOR) announced today that executive management will present at the following investor conferences in early September:   The Morgan Stanley Global Healthcare Conference at the Grand Hyatt in New York City.  

ShangPharma Corporation (NYSE:SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that it will hold its 2011 annual general meeting of shareholders at 42nd Floor, Edinburgh Tower, The Landmark, 15 Queen's Road, Central, Hong Kong on October 14, 2011 at 10:00 AM (Hong Kong time).

United Therapeutics Corporation (NASDAQ:UTHR) announced today the completion of its FREEDOM-C(2) Phase 3 trial of treprostinil diethanolamine (oral treprostinil), an investigational sustained release oral formulation of treprostinil, a stable synthetic form of prostacyclin, in patients with pulmonary arterial hypertension (PAH).



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