On August 29, 2013 Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, reported that Janssen Pharmaceutica NV has received clearance to commence a Phase I clinical trial of a Fibroblast Growth Factor Receptor (FGFR) kinase inhibitor from its collaborative, cancer drug discovery program with Astex (Press release, Cancer Research Technology, AUG 29, 2013, View Source [SID1234523520]). The regulatory approval required to take the compound into Phase I triggers a milestone payment to Astex of £3.5 million (US$5.4 million). Astex is also eligible to receive further milestones during clinical development and royalties on commercialization of products derived from the collaboration.

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The FGFR inhibitor program between Janssen and Astex originated from an earlier collaboration between Astex, Cancer Research Technology, the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre (NCC), and the Northern Institute for Cancer Research, Newcastle University, UK. As part of the collaboration, Astex applied its fragment-based drug discovery approach, Pyramid, to identify lead compounds inhibiting FGFR kinase. The partnership with Janssen was entered into in June 2008. Janssen is responsible for the clinical and regulatory development of all products arising from the collaboration and for their global commercialization.

Harren Jhoti, PhD, president of Astex, commented: "We are delighted that Janssen has received approval to commence a Phase I study on this FGFR kinase inhibitor, a drug that has the potential to address a significant area of unmet medical need. This milestone underscores how effective collaborations between leading research institutions, biotech companies and pharmaceutical partners can be in delivering new drug candidates for patients."

On August 19, 2013 Cell Therapeutics reported that the Transparency Commission (Commission de la Transparence or CT) of the French National Health Authority (Haute Autorite de Sante or HAS) has granted market access for the medicinal product PIXUVRI (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (patients with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy) (Press release , AUG 18, 2013, View Source;p=RssLanding&cat=news&id=1848275 [SID:1234500566]). The next and final step in France’s pharmaceutical reimbursement process is inclusion on the list of medicines approved for hospital use and subsequent publication in the Journal Officiel in France, which CTI now intends to pursue.
The CT noted that aggressive NHL is a serious disease and that there are no standard treatments for patients with this stage of disease. All registered pharmaceuticals in France are subjected to an evaluation process known as Evaluation of Therapeutic Benefit (Amelioration du Service Medical Rendu, or ASMR) by the CT, with the resulting evaluation expressed as a classification between 1 and 6. The CT rated PIXUVRI at level 5, which allows PIXUVRI to be included in the reimbursed drugs list for hospital use. The CT will reassess the ASMR rating for PIXUVRI within two years.

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(Company Web Page, AllaChem, AUG 16, 2013, View Source [SID:1234502046])

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(Filing, 10-Q, Prothena, AUG 13, 2013, View Source [SID:1234505969])

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On August 12, 2013 Vical reported top-line results from a Phase 3 trial of Allovectin (velimogene aliplasmid), an investigational intratumoral cancer immunotherapy, in patients with metastatic melanoma (Press release Vical, AUG 12, 2013, View Source [SID:1234501043]). The 390-subject trial failed to demonstrate a statistically significant improvement vs. first-line chemotherapy for either the primary endpoint of objective response rate at 24 weeks or more after randomization or the secondary endpoint of overall survival. Trial data will be further analyzed and detailed results will be submitted for publication.

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"We are disappointed that the trial did not meet either the primary or secondary efficacy endpoints, even though we believe it was well-designed and well-executed," said Vijay B. Samant, President and Chief Executive Officer of Vical. "Based on this outcome, we are terminating the Allovectin program and focusing our resources on our infectious disease vaccine programs." Mr. Samant added, "We would like to recognize all of the patients and their families, trial investigators and employees who participated in the conduct of this trial and thank them for their efforts."