Biotech Values

[DewDiligence]

GENR’s Phase-2 combo trial with Visudyne starts:

[The trial has been expanded from 30 to 45 patients in order to include 15 patients who receive the 10mg dose as well 15 each who receive 20mg and 40mg (as originally planned).

GENR is saying (at today's UBS webcast) that the inclusion fo the 10mg dose is the reason for the delay in starting the combo trial. OK, but GENR cut things pretty close by waiting six months from the FDA’s acceptance of the IND to start this trial. GENR’s getting this trial started reduces, but not entirely eliminate, my concern about manufacturing.

Another note: some interim data from the 18-patient PK study will be available later this year.]

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Genaera Initiates Third Phase II Clinical Trial of Squalamine in Macular Degeneration

Tuesday September 28, 8:02 am ET

Clinical Trial of Squalamine in Combination With Visudyne(R)

PLYMOUTH MEETING, Pa., Sept. 28 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR - News) today announced the opening of enrollment and expansion of the third U.S. Phase II clinical trial of its first-in-class small molecule anti-angiogenic drug candidate, squalamine, for the treatment of the "wet" age-related macular degeneration (AMD).

The MSI-1256F-208 study will evaluate three different doses (10, 20 or 40 mg) of squalamine in combination with an initial Visudyne® treatment in 45 patients with wet AMD. Specifically, this study will evaluate the safety and effects of systemically administered squalamine pretreatment on the actions of Visudyne® and the effect of administering squalamine after Visudyne®. Based on its mechanism of action, squalamine has the potential to inhibit detrimental effects of the VEGF 'burst' that commonly occurs after Visudyne® treatment. The multi-center, randomized, controlled, masked study includes monthly squalamine therapy this maintenance therapy and twelve months subsequent follow-up for each patient.

As announced in April 2004, exploratory Phase II trial, MSI-1256F-208, was originally designed to as a 30 patient trial to evaluate two different doses of squalamine (20 or 40mg) in combination with an initial Visudyne® treatment compared to a Visudyne control group. However, based on early results from an ongoing 18 patient Phase II pharmacokinetic and safety trial, MSI-1256F-207, evaluating doses of 10, 20 and 40 mg over four months, Genaera has amended the MSI-1256F-208 protocol to add a 10 mg squalamine dose.

"Further study of a 10 mg dose of squalamine is certainly warranted scientifically based on our preliminary results from the MSI-1256F-207 study. Thus, expanding the 208 trial to include a 10 mg dose is prudent at this time," commented retinal specialist and study advisor Charles A. Garcia, MD, Bernice Weingarten Distinguished Professor of Ophthalmology and Visual Science, University of Texas Health Science Center at Houston.

"We are pleased to advance our clinical development plan for squalamine in AMD. With the start of this trial, all three of our planned Phase II trials are now underway," commented Roy C. Levitt, MD, President and Chief Executive Officer. "While we have delayed the start of the 208 study, we believe the additional data on the safety and efficacy of a 10 mg dose of squalamine with Visudyne, the only approved therapy for wet AMD, will be beneficial. Results from the 207 study [the 18-patient PK study] should be available later this year as enrollment completes and data from all treatment groups mature."
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