Genaera presents positive preliminary results for Evizon, Visudyne for blindness

By Jennifer Chiou

New York, Oct. 19 - Genaera Corp. announced positive preliminary results from a U.S. Phase II clinical trial of Evizon squalamine lactate with concomitant photodynamic therapy with Visudyne (PDT) compared to PDT alone in 45 subjects with wet age-related macular degeneration (AMD).

Visudyne is Vancouver-based QLT Inc.'s intravenous injection for AMD, which, resulting from angiogenesis, is the leading cause of legal blindness among adults age 50 and older.

The combination of the drugs was well tolerated in all subjects with no drug-related serious adverse events. Genaera said the most common adverse events involved infusion site reactions.

At 29 weeks, results showed a 5.2-letter difference in mean change in visual acuity from study entry between subjects treated with 40mg of Evizon plus PDT and PDT alone. Subjects treated with 40mg of Evizon and concomitant PDT gained an average of 0.4 letters in visual acuity compared to study entry while those treated with PDT alone lost an average of 4.8 letters.

In addition, 90% of subjects treated with 40mg of Evizon with concomitant PDT had stable vision - defined as a gain or loss of less than 15 letters.

"We are pleased that we have confirmed the safety of the use of Evizon with concomitant PDT," Genaera president and chief operating officer John "Jack" L. Armstrong said in a news release.

"Additionally, we are encouraged by the stabilization of vision shown in this small study, as well as the lower incidence of the need for retreatment with PDT in those subjects treated with Evizon."

Genaera also has Phase III and multiple Phase II trials of Evizon in wet AMD. MSI-1256F-301 is a Phase III international trial. MSI-1256F-209 is the largest of Genaera's three Phase II studies and is designed to evaluate the safety and efficacy of Evizon over a two-year period in 100 subjects with wet AMD.

Evizon is a synthetic small molecule administered systemically that directly interrupts and reverses the angiogenic process.

Genaera is a Plymouth Meeting, Pa., biopharmaceutical company with four products in development for the treatment of eye, cancer and respiratory disorders.

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