Genaera Presents Positive Preliminary Clinical Results for EVIZON(TM) for Treatment of Age-Related Macular Degeneration at the Annual AAO Meeting
Wednesday October 19, 8:30 am ET
PLYMOUTH MEETING, Pa., Oct. 19 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR - News) today announced positive preliminary results from a U.S. Phase II clinical trial (MSI-1256F-208) of EVIZON(TM) (squalamine lactate) with concomitant photodynamic therapy with Visudyne® (PDT) (QLT Incorporated, Vancouver, Canada) compared to PDT alone in 45 subjects with wet age-related macular degeneration (AMD). EVIZON with concomitant PDT was well tolerated in all subjects with no drug-related serious adverse events reported to date. The most common adverse events involved infusion site reactions. These events were generally mild and were distributed evenly across the EVIZON plus PDT treatment groups. Preliminary data were presented for 40mg or 20mg of EVIZON with concomitant PDT compared with PDT-alone at the 109th Annual Meeting of the American Academy of Ophthalmology (AAO) in Chicago, Illinois.
At twenty-nine weeks, in addition to meeting the study's primary goal of demonstrating safety, secondary endpoint 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 as measured by the Early Treatment of Diabetic Retinopathy (ETDRS) protocol. 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. Of the subjects treated with the combination of 40mg of EVIZON plus PDT, 10% (1/10) required a second PDT treatment compared to 47% (8/17) of those in the PDT-alone arm.
At twenty-nine weeks, 90% (9/10) of subjects treated with 40mg of EVIZON with concomitant PDT had stable vision (defined as a gain or loss of less than 15 ETDRS letters). Seventy-one percent of subjects treated with PDT-alone had stable vision. Twelve percent (2/17) of subjects treated with PDT alone had a gain of 15 letters or more from study entry. Ten percent (1/10) of the subjects treated with 40mg of EVIZON plus PDT lost greater than 15 letters from study entry compared to 18% (3/17) in the PDT-alone arm, of which 12% (2/17) lost 30 letters or more. No subjects in the 40mg EVIZON plus PDT group lost 30 letters or more. Subjects treated with 20mg of EVIZON plus PDT had results similar to those treated with PDT-alone with 78% (7/9) of subjects with stable vision.
"We are pleased that we have confirmed the safety of the use of EVIZON with concomitant PDT," commented John (Jack) L. Armstrong, President and Chief Operating Officer of Genaera Corporation. "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."
MSI-1256F-208 is a Phase II trial designed to evaluate in 45 subjects with wet AMD the safety and clinical effects of three different doses of EVIZON (10mg, 20mg or 40mg) along with initial concomitant PDT treatment in 10 subjects per group, or PDT-alone in 15 control subjects. Specifically, this study is designed to evaluate the safety and effects of systemically administered EVIZON before and after PDT. The multi-center, randomized, controlled, masked study also includes monthly EVIZON maintenance therapy through six months, along with an additional twelve months of open-label treatment and follow-up for each patient.
Other Ongoing Clinical Trials
Genaera is currently conducting a Phase III and multiple Phase II trials of EVIZON in wet AMD at multiple investigational sites. In January 2005, the Food and Drug Administration (FDA) selected EVIZON for participation in the Continuous Marketing Application (CMA) Pilot 2 program. In October 2004, the FDA granted EVIZON Fast Track designation.
MSI-1256F-301 is a Phase III international trial designed to enroll subjects with predominantly classic, minimally classic and occult forms of wet AMD. The multi-center, randomized, double-masked, controlled trial will evaluate two doses of EVIZON (40mg and 20mg) versus placebo, given once weekly for four weeks followed by maintenance doses every four weeks until week 104. PDT is allowed as background therapy for all subjects in this study if deemed necessary and appropriate by the study physician. Enrollment in this trial is ongoing.
MSI-1256F-209 is the cornerstone and 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. This Phase II multi-center, randomized, double-masked, controlled study will evaluate two dose levels of EVIZON (20mg or 40mg) given once weekly for four weeks, followed by maintenance doses once every four weeks until week 48. At the end of 48 weeks of therapy, each subject will be followed for a further twelve months. PDT is allowed as background therapy for all subjects in this study if deemed necessary and appropriate by the study physician. Enrollment in this trial is closed.
MSI-1256F-207 was a Phase II pharmacokinetic and safety trial that evaluated 18 subjects with AMD at three different doses of EVIZON (10mg, 20mg or 40mg) over four months. In this multi-center, open-label, parallel group study, EVIZON was given once weekly for four weeks, and then all subjects were followed out to month 4 with no further treatment after week four. All subjects in the 207 trial have completed therapy and follow up and depending on their response, subjects may have continued to receive EVIZON as needed for up to one additional year in a separate study (MSI-1256F-211).
For information about participation in EVIZON clinical trials, subjects and physicians may call Genaera's Clinical Trial Hotline at (800) 299-9156.
About EVIZON(TM)
EVIZON is a unique first in class synthetic small molecule administered systemically that directly interrupts and reverses multiple facets of the angiogenic process. Working within activated endothelial cells, EVIZON inhibits growth factor signaling including VEGF, integrin expression, and reverses cytoskeletal formation, thereby resulting in endothelial cell inactivation and apoptosis. Systemically administered EVIZON 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 EVIZON 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 EVIZON may have a role in the treatment of human choroidal neovascular membrane formation that underlies the pathology of wet AMD.
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