Replies to post #1931 on Biotech Values

[EZ2]

dew --- 'exactly' WHAT does this mean ??

"A second exploratory Phase II trial is designed to evaluate the effects of two different doses of squalamine in combination with an initial Visudyne® treatment in 30 patients with AMD. Specifically, this study will evaluate the potential benefits of squalamine pretreatment on the actions of Visudyne® and the added potential benefit of dosing squalamine after Visudyne® to inhibit the potentially detrimental effects of the VEGF 'burst' that commonly occurs after Visudyne® treatment. The multi-center, randomized, controlled, masked study includes monthly squalamine maintenance therapy, and twelve months subsequent follow-up for each patient."

[DewDiligence]

GENR launches main phase-2 AMD trial:

[This is the “209” trial, which is the main phase-2 trial to test Squalamine as a single agent. The two other phase-2 trials are the “207” pharmacokinetic study (already underway) and the “208” study of Squalamine in combination with Visudyne (not yet started). For additional background on these trials, please see: #msg-2920654, #msg-2916397, #msg-2914787, and #msg-3006307.]

http://biz.yahoo.com/prnews/040616/nyw062_1.html

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Genaera Initiates Second Phase II Macular Degeneration Clinical Trial for Squalamine

PLYMOUTH MEETING, Pa., June 16 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR) today announced the opening of enrollment for the second and largest of its U.S. Phase II clinical trials of its first in class small molecule systemically administered anti-angiogenic drug, squalamine, for the treatment of the "wet" age-related macular degeneration (AMD).

This Phase II study is an exploratory trial designed to evaluate the safety and efficacy of squalamine as first-line therapy in 100 patients with AMD over a two year period. This Phase II multi-center, randomized, double masked, controlled study will evaluate two dose levels of squalamine (20 mg or 40 mg) given once weekly for four weeks, followed by maintenance doses once every four weeks through week 48. At the end of therapy, each patient will be followed for an additional 52 weeks.

"This trial, the second to start of three planned, is the cornerstone of Genaera's Phase II studies. This Phase II trial will be running while we are actively preparing for our Phase III trials anticipated to begin in early 2005. Analyses from this study are to be used in coordinating our Phase III activities," commented Roy C. Levitt, MD, President and Chief Executive Officer. "We are very fortunate to have an outstanding group of retinal experts and their investigative teams participating in this exciting study. These investigators and their associates are highly skilled in the diagnosis and use of approved and investigational treatments for patients with wet age-related macular degeneration."

Squalamine Mechanism of Action

Squalamine directly interrupts and reverses multiple facets of the angiogenic process. Working within activated endothelial cells, squalamine inhibits growth factor signaling including VEGF, integrin expression, and reverses cytoskeleton formation, thereby resulting in endothelial cell inactivation and apoptosis. Systemically administered squalamine inhibits abnormal angiogenesis in rodent models of retinopathy of prematurity, and the development of choroidal neovascular membranes in rat models of AMD. Additional preclinical studies have demonstrated that systemic squalamine administration is effective in reaching abnormal ocular blood vessels in primates, and leads to partial regression and inhibition of new abnormal vessels in the eye. These results support that squalamine may have a role in the treatment of human choroidal neovascular membrane formation that underlies the pathology of wet AMD.
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