TLON receives Marqibo SPA. BNVI Menerba update tmrw + QLTI

Aug 29, 2011 No Comments by

Bionovo, Inc. (NASDAQ: BNVI) announced today that it will host a conference call on Tuesday, August 30, 2011, to discuss the results of the completed Tolerability Trial of its drug candidate for menopausal hot flashes, Menerba, at 2:00 p.m. Pacific Time. It will also discuss its overall clinical development plan and the impending Phase 3 study scheduled to start shortly.

QLT Inc. (Nasdaq:QLTI) (TSX:QLT) today announced results of its Phase 2 clinical study on the efficacy and safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in subjects with ocular hypertension (OH) and open-angle glaucoma (OAG). The primary endpoint was the mean change in IOP from baseline (measured as mmHg) at 2 weeks. After 2 weeks of L-PPDS treatment, IOP showed a statistically significant mean change from baseline of -6.2 mmHg (95% C.I. -6.8, -5.6). At the end of 2 weeks, 73% of subjects showed an IOP reduction vs. baseline of 5 mmHg or greater and 51% of subjects showed a reduction of 6 mmHg or greater. The mean percentage change in IOP from baseline at 2 weeks was -24.3%, which was statistically significant (95% C.I. -26.7, -21.9).

Talon Therapeutics, Inc., (OTCBB:TLON), announced today it has reached agreement with FDA regarding a special protocol assessment (SPA) for its planned Phase 3 study of Marqibo in adults with newly diagnosed Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).Talon submitted a NDA to the FDA in July 2011 seeking accelerated approval of Marqibo in adult Ph- ALL, in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy. The Phase 3 study now under SPA, named HALLMARQ (Halting newly diagnosed Adult acute Lymphoblastic Leukemia with Marqibo containing chemotherapy), is intended to be a confirmatory study to be completed following the accelerated approval of Marqibo. Talon expects to know if the NDA has been accepted for filing by the FDA in mid-September 2011.

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Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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