Therapeutics News and Research

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Results from Phase I dose-escalation study of AT-101 announced

Ascenta Therapeutics announced today that encouraging results from a Phase I dose-escalation study of two combination therapy regimens containing AT-101, an oral, pan-Bcl-2 inhibitor, in patients with the most malignant type of brain tumor, were described in an oral presentation at the 2009 Joint Meeting of the Society for NeuroOncology (SNO) and AANS/CNS Section on Tumors in New Orleans, Louisiana (Concurrent Session VI: Radiation Oncology, October 23, 2009; Abstract # 449).

26 Oct 2009

SuperGen and GSK team up to discover and develop cancer therapeutics based on epigenetic targets

SuperGen, Inc. (NASDAQ:SUPG) and GlaxoSmithKline (NYSE:GSK) have entered into a multi-year collaboration to discover and develop cancer therapeutics based on epigenetic targets.

26 Oct 2009

USPTO reaffirms the validity of ExonHit Therapeutics' SpliceArray patent

ExonHit is pleased to announce that the United States Patent and Trademark Office (“USPTO”) notified the Company of its intent to issue a Re-examination Certificate in connection with ExonHit’s US Patent n° 6,881,571 directed to the use of its SpliceArray™ technology.

26 Oct 2009

Gene therapy may help improve congenital blindness in children

Born with a retinal disease that made him legally blind, and would eventually leave him totally sightless, the nine-year-old boy used to sit in the back of the classroom, relying on the large print on an electronic screen and assisted by teacher aides. Now, after a single injection of genes that produce light-sensitive pigments in the back of his eye, he sits in front with classmates and participates in class without extra help. In the playground, he joins his classmates in playing his first game of softball.

26 Oct 2009

Orexigen Therapeutics announces new data from COR-I, COR-II and COR-Diabetes trials for Contrave

Orexigen® ( )Therapeutics, Inc today announced new data from the COR-I, COR-II and COR-Diabetes trials for Contrave® (bupropion SR/ naltrexone SR) to expand on top-line results announced in July. Contrave is the first of the Company's two late stage candidates for the treatment of obesity.

26 Oct 2009

CHMP grants positive opinion to extend the use of Angiox to patients undergoing PCI

The Medicines Company announced today that the Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion applicable to all Member States of the European Union/European Economic Area that will extend the use of Angiox (bivalirudin) to include patients with heart attacks (so-called ST segment elevation myocardial infarction (STEMI)) undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI).

24 Oct 2009

Newcardio expert to present clinical validation data of Phase I and TQT studies on ECG

NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic and services company, today announced that Dr. Sam George, NewCardio's Senior Consultant, will join a distinguished roster of speakers, moderators and panelists at the Cardiac Safety Research Consortium (CSRC) annual meeting in Maryland at the Marriot Bethesda, Pooks Hill location on October 29-30, 2009.

23 Oct 2009

Archexin has potential to target and treat multiple life-threatening cancers, finds new study

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and central nervous system (CNS) therapeutics, today announced the results of an animal study that further demonstrates the company’s Phase II oncology drug, Archexin™, as having the potential to target and treat multiple life-threatening cancers.

23 Oct 2009

Celgene announces fiscal 2009 third-quarter results

Celgene Corporation announced non-GAAP (Generally Accepted Accounting Principles) net income of $259.8 million, or non-GAAP earnings per diluted share of $0.56 for the quarter ended September 30, 2009. Non-GAAP net income for the third quarter of 2008 was $185.9 million, or non-GAAP earnings per diluted share of $0.40.

22 Oct 2009

Faster insulin absorption for varying insulin doses and PH20 concentrations demonstrated

Halozyme Therapeutics, Inc. today announced dose response study results that demonstrated faster insulin absorption and increased peak insulin concentrations after co-administration of its recombinant hyaluronidase enzyme (rHuPH20 or PH20) with regular human insulin and with insulin lispro. The enhanced absorption effects were observed at clinically relevant insulin doses across a broad range of PH20 concentrations.

22 Oct 2009

FDA extends Acorda Therapeutics' Fampridine-SR PDUFA goal date

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its review of the New Drug Application (NDA) for Fampridine-SR to January 22, 2010. The original Prescription Drug User Fee Act (PDUFA) date for this priority review application was October 22, 2009.

22 Oct 2009

Highlights of Cell Therapeutics' pixantrone study to be presented at the Lymphoma and Myeloma Conference

Cell Therapeutics, Inc. announced that Dr. Richard Van der Jagt of the Ottawa General Hospital will present at the Lymphoma and Myeloma 2009 Conference in New York an overview of CTI's pixantrone phase II and phase III clinical studies that demonstrated high rates of complete remission (CR) in relapsed/refractory aggressive and indolent non-Hodgkin's lymphoma (NHL) patients.

22 Oct 2009

Clinical performance study reveals the accuracy and precision of TRUE2go system

Home Diagnostics, Inc., a leading developer, manufacturer, and marketer of blood glucose monitoring systems, today announced the results of a TRUE2go™ clinical performance study published in the October 2009 issue of the journal Diabetes Technology & Therapeutics. The study, “Clinical Performance of the TRUE2go Blood Glucose System – A Novel Integrated System for Meter and Strips,” demonstrated the accuracy and precision of the TRUE2go system and found that it was both easy and convenient to use by patients.

22 Oct 2009

France Biotech announces its 5th Bioethics Forum

France Biotech, the French association of life science businesses and their partners (www.france-biotech.org) today announced that its 5th Bioethics Forum (organized in collaboration with the Eurobiomed cluster) will take place on Friday, December 11th, at the Musée du Carre d’Art venue in Nîmes.

22 Oct 2009

Halozyme Therapeutics commences patient dosing in Phase 3 Enhanze trial with Herceptin

Halozyme Therapeutics, Inc. and Roche today announced dosing of the first patient in a Phase 3 registration trial using Enhanze™ technology (rHuPH20, recombinant human hyaluronidase) in a subcutaneous formulation with Roche’s anticancer biologic, Herceptin (trastuzumab).

22 Oct 2009

Cangene Corporation announces financial results for the fiscal year ended July 31, 2009

Cangene Corporation today reports financial results for the fiscal year ended July 31, 2009.

22 Oct 2009

GE and Eli Lilly develop tissue-based biomarker technology for cancer therapy

Scientists at GE Global Research, and researchers at Eli Lilly and Company today announced a significant advancement in cancer research resulting from the two companies’ collaboration formed in October 2007.

22 Oct 2009

Positive results from Argos Therapeutics' personalized immunotherapy candidate AGS-004 Phase 2a trial

Argos Therapeutics today announced two presentations at the AIDS Vaccine 2009 conference, detailing positive viral load, immune response and safety data from an ongoing Phase 2a trial of AGS-004, its personalized immunotherapy candidate. AGS-004 is a product of the Company’s Arcelis™ technology, and is a personalized, RNA-loaded, dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique HIV viral burden.

21 Oct 2009

FDA grants Fast Track designation for MacuSight's Perceiva

MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, today announced that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for Perceiva, the company's proprietary ocular sirolimus product, for the treatment of diabetic macular edema (DME).

21 Oct 2009

Gamida Cell and Cellerixon collaborate to develop new line of cell therapeutics

Gamida Cell Ltd. and Cellerix, S.A. announced today that the companies are collaborating on a feasibility study to evaluate the added value of combining the proprietary technologies of each.

21 Oct 2009

Therapeutics News and Research

Results from Phase I dose-escalation study of AT-101 announced

SuperGen and GSK team up to discover and develop cancer therapeutics based on epigenetic targets

USPTO reaffirms the validity of ExonHit Therapeutics' SpliceArray patent

Gene therapy may help improve congenital blindness in children

Orexigen Therapeutics announces new data from COR-I, COR-II and COR-Diabetes trials for Contrave

CHMP grants positive opinion to extend the use of Angiox to patients undergoing PCI

Newcardio expert to present clinical validation data of Phase I and TQT studies on ECG

Archexin has potential to target and treat multiple life-threatening cancers, finds new study

Celgene announces fiscal 2009 third-quarter results

Faster insulin absorption for varying insulin doses and PH20 concentrations demonstrated

FDA extends Acorda Therapeutics' Fampridine-SR PDUFA goal date

Highlights of Cell Therapeutics' pixantrone study to be presented at the Lymphoma and Myeloma Conference

Clinical performance study reveals the accuracy and precision of TRUE2go system

France Biotech announces its 5th Bioethics Forum

Halozyme Therapeutics commences patient dosing in Phase 3 Enhanze trial with Herceptin

Cangene Corporation announces financial results for the fiscal year ended July 31, 2009

GE and Eli Lilly develop tissue-based biomarker technology for cancer therapy

Positive results from Argos Therapeutics' personalized immunotherapy candidate AGS-004 Phase 2a trial

FDA grants Fast Track designation for MacuSight's Perceiva

Gamida Cell and Cellerixon collaborate to develop new line of cell therapeutics

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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