NVGN Soars, NYMX, PPHM Progress, ISIS Pockets Payment, THRX Gets A Date With FDA

pills 022013

Seeking to improve health care delivery for seniors, particularly in the areas of oncology, urology and transplantation, Humana Inc. (HUM) and Astellas Scientific & Medical Affairs Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., have entered into multi-year research collaboration.

HUM closed Tuesday's trading at $73.01, down 6.39%.

Isis Pharmaceuticals Inc. (ISIS) announced Tuesday that it has pocketed a $7.5 million milestone payment from GlaxoSmithKline plc (GSK), following the initiation of a phase 2/3 clinical study for ISIS-TTRRx.

ISIS-TTRRx is an antisense drug in development with GlaxoSmithKline for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues.

ISIS closed Tuesday's trading at $14.95, up 3.60%.

Novogen Ltd. (NVGN) surged as much as 263% to $7.60 in regular trading on Tuesday after the company announced that its lead experimental drug, CS-6, has proven to be highly active against ovarian cancer stem cells in laboratory studies.

Cancer stem cells have been identified in a range of cancers including gut, skin, ovarian and brain cancers and leukaemia. Being almost completely resistant to radiotherapy and standard anti-cancer drugs, the cancer stem cells are thought to be the cause of cancer relapse.

Graham Kelly, Novogen CEO said, "it is important to point out that this is early days and we have some way to go before we will have clinical evidence, but there is no doubt that this news elevates CS-6 and the super-benzopyran family of drugs to which it belongs into an entirely new clinical dimension where we hope it will be possible to provide a comprehensive cancer treatment."

Nymox Pharmaceutical Corp. (NYMX) on Tuesday announced that its lead drug candidate, NX-1207 has shown no evidence of any allergic reaction to the drug either on first injection or repeat injection to date.

NX-1207 is in late stage phase III development in the U.S. for the treatment of benign prostatic hyperplasia, a common condition of older men associated with growth in prostate size as men age.

NYMX closed Tuesday's trading 1.12% higher at $6.31.

NxStage Medical Inc. (NXTM) on Tuesday said it has received CE Mark approval for nocturnal home hemodialysis with the NxStage System One.

The company expects to begin marketing the System One for nocturnal dialysis in countries that recognize the CE Mark approval process in the second half of 2013.

NXTM closed Tuesday's trading 1.38% higher at $11.75.

Oncolytics Biotech Inc. (ONC.TO) (ONCY) may commence an underwritten public offering of common shares, depending on market and other conditions. The terms of the offering are yet to be revealed.

ONCY dropped 4.50% to $4.46 in extended trading on Tuesday.

Osiris Therapeutics Inc. (OSIR) has been designated as the Orphan Drug title holder for Prochymal for the treatment of acute graft versus host disease by the European Medicines Agency.

Prochymal is approved in Canada and New Zealand for the management of acute graft versus host disease in children and is available for adults and children in eight countries including the United States, under an Expanded Access Program. Prochymal is currently in a phase III trial for refractory Crohn's disease and in a phase II trial for acute myocardial infarction.

OSIR closed Tuesday's trading at 7.65, up 8.97%.

Peregrine Pharmaceuticals Inc. (PPHM) on Tuesday announced that there was a 60% improvement in median overall survival in patients treated with Bavituximab plus Docetaxel compared to control arm in a phase II trial of second-line non-small cell lung cancer.

Additional data from the trial, including updated subgroup analysis and safety data are expected to be reported at an upcoming scientific meeting.
Joseph Shan, vice president of clinical and regulatory affairs at Peregrine said, "These compelling results strongly support advancing the 3mg/kg Bavituximab plus Docetaxel combination into Phase III development in second-line NSCLC."

Stem Cell Therapeutics (SSS.V) on Tuesday announced a joint-venture agreement with Reneu Inc. and Nexgen Medical Systems Inc.

The agreement allows ReNeu to use NexGen's FDA-cleared EViTAR line of proprietary intracranial delivery systems and Stem Cell Therapeutics' NTx-265, -428 and -488 covering the proprietary use of drugs for the regeneration of endogenous neural stem cells.

Stem Cell Therapeutics will own 50% of the joint-venture for which the definitive agreement is anticipated within 60 days, subject to final due-diligence and usual conditions.

Sanofi's (SNY) New Drug Application for Lixisenatide, the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus, has been accepted for review by the FDA.

Lixisenatide was approved in the European Union on Feb. 1, 2013, and is expected to be launched as of late Q1 2013, under the proprietary name Lyxumia.

The stock touched a new 52-week high of $49.70 on Tuesday before closing at $49.69.

The FDA has accepted the New Drug Application for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease, and a decision date has been set for Dec.18, 2013.

UMEC/VI, with proposed brand name ANORO, is being developed by GlaxoSmithKline plc (GSK) and Theravance Inc. (THRX).

The Marketing Authorisation Application for UMEC/VI submitted in the European Union has been validated for assessment by the European Medicines Agency.

THRX closed Tuesday's trading 0.45% higher at $22.23.

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