Lev Pharmaceuticals Meets Primary Endpoint in Pivotal Phase III Prophylactic Trial for Hereditary Angioedema (HAE)
Company intends to seek label indication for Cinryze™ to include prevention of HAE attacks
Monday, September 10, 2007. Lev Pharmaceuticals, Inc. (“Lev” or the “Company”) (OTC Bulletin Board: LEVP.OB – News) today announced positive results from its pivotal U.S. Phase III trial of C1 inhibitor, to be marketed as Cinryze™, for the prophylactic treatment of hereditary angioedema (HAE), also known as hereditary C1 inhibitor deficiency. In the study, the protocol defined primary endpoint was achieved, showing a clinically and statistically significant reduction in the number of HAE attacks. Lev will host a live conference call and audio webcast on Tuesday, September 11, 2007 at 1PM EDT to discuss matters mentioned in this press release.
Based on the positive results of this study, the Company intends to amend its Biologics License Application (BLA) for Cinryze™ (C1 inhibitor), which was submitted to the Food and Drug Administration (FDA) on July 31, 2007, to include the prevention of HAE attacks. Cinryze™ is being developed as a replacement therapy for both the acute and prophylactic treatment of HAE.
In the 24 week, double-blind, placebo controlled study, a total of 24 patients were randomly assigned to one of two treatment groups: twelve weeks of Cinryze™ treatment followed by 12 weeks of placebo or 12 weeks of placebo treatment followed by 12 weeks of Cinryze™. Patients received twice-weekly doses of Cinryze™ or placebo. The primary endpoint was met with a 53% reduction in the number of attacks in the Cinryze™ group (p<0.0001). Secondary endpoints in the study also showed highly significant differences in favor of Cinryze™, including a 66% reduction in days of swelling (p<0.0001) and decreases in the average severity of attacks (p=0.0008) and average duration of attacks (p=0.0004).
“The results of this study, combined with the results of our acute trial, support the potential of Cinryze™ to become a comprehensive treatment option for HAE patients in the United States,” said Joshua D. Schein, Ph.D., Lev’s Chief Executive Officer.
Commenting on the positive Phase III data, Judson Cooper, Lev’s Chairman of the Board said, “These compelling results are a validation of Lev’s ability to advance the Cinryze™ program through this Phase III trial, reflecting a significant value proposition for our shareholders. The successful outcome of this study represents an important accomplishment in the evolution of Lev.”
The CHANGE study (C1 inhibitor in Hereditary Angioedema Nanofiltration Generation evaluating Efficacy) is a pivotal Phase III clinical trial designed to examine the safety and efficacy of Cinryze™ in treating acute HAE attacks and as a prophylactic treatment to prevent HAE attacks. The prophylactic study examined the safety and efficacy of Cinryze™ in HAE patients suffering from at least two HAE attacks per month. As part of the CHANGE trial, Lev is also conducting two open label studies to provide HAE patients with continued access to Cinryze™. To date, more than 1,500 doses of Cinryze™ have been administered in all parts of the CHANGE trials with several patients having individually received over 100 doses.
Additionally, Cinryze™ was well tolerated with an adverse event profile no different from placebo. The most common adverse reactions observed were injection site rash and lightheadedness. No drug-related serious adverse events (SAEs), no immunogenicity and no decrease in efficacy have been observed.
“The CHANGE study represents an important milestone in the development of C1 inhibitor for HAE and the patients afflicted with this chronic, severely debilitating and life-threatening disease,” said William Lumry M.D., Clinical Professor of Medicine at the University of Texas Health Science Center, Dallas, TX and an investigator for the CHANGE trial. Dr. Lumry added, “Treatment options are extremely limited today and these results strongly support the potential for Cinryze™ to markedly improve the lives of patients with HAE.”
On March, 14 2007, Lev announced the successful completion of its pivotal Phase III clinical trial for the acute treatment of HAE, which demonstrated a clinically and statistically significant reduction in the time to unequivocal relief of acute HAE attacks.
On July 31, 2007, Lev announced that it submitted a BLA to the FDA seeking approval of Cinryze™ for the acute treatment of HAE. Lev is the first company to submit a licensing application for the acute treatment of HAE in the United States.
As previously mentioned, Lev will host a live conference call and audio webcast on Tuesday, September 11, 2007 at 1PM EDT to discuss matters mentioned in this press release.
To access the live webcast, please click on this link.
A replay of this webcast will be available for 30 days.
This is an important milestone for all sufferers of HAE, of which I happen to be one. Five of my immediate family members have this genetic disorder and fortunately all of their symptoms are adequately controlled by danazol, an anabolic steroid. Danazol, however, does not work for me and Cinryze(tm) is the only treatment available that allows me any chance at all of even a half-way productive and pain-free life. May the Goddess guide the FDA to make a decision (this time) to approve this treatment, which has been available in Europe for over ten years.