Lev Pharmaceuticals, Inc. (OTC Bulletin Board: LEVP) today announced that investigators presented results from a pivotal, Phase III trial of Cinryze (C1 inhibitor), in patients with acute attacks of hereditary angioedema (HAE), also known as C1 Inhibitor Deficiency, a genetic condition that causes recurrent and potentially-life threatening inflammation in the larynx, abdomen, face, extremities and urogenital tract. The results were presented at the 2007 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Dallas.
The results from the Phase III, double-blind, placebo-controlled trial showed that patients undergoing an HAE attack who received treatment with Cinryze saw symptoms begin to fade in a median time of 2 hours, compared with greater than 4 hours for patients who received placebo. The findings were statistically significant (p=0.026). The study also met secondary endpoints, with Cinryze treatment significantly better than placebo in providing unequivocal relief within 4 hours, as well as in complete resolution of the defining symptoms of the attack.
"These results offer the best evidence to date that Cinryze can make an immediate and marked difference in the lives of the thousands of Americans who must live with the uncertainty of acute HAE attacks, a condition with no approved treatment," said Bruce L. Zuraw, MD, Professor of Medicine at the University of California-San Diego, who led the research. "We believe we have demonstrated that use of Cinryze provides a benefit that is statistically significant, as well as a benefit that will have a significant impact on the quality of life of people with HAE."
A second presentation at the ACAAI meeting demonstrated that prophylactic treatment with Cinryze could prevent HAE attacks associated with surgery. The patient in the case study, a 51-year-old male with HAE, underwent uncomplicated mitral valve surgery. The case marked the first use in the United States of Cinryze as a prophylactic treatment in a patient undergoing on-pump cardiothoracic surgery, and it further supports the prophylactic use of Cinryze. Lev announced earlier this year positive results from a Phase III trial assessing the ability of Cinryze replacement therapy, given twice weekly, to reduce the number of HAE attacks.
"These data, taken together, provide convincing evidence of the efficacy of Cinryze. We look forward to continuing to work with the U.S. Food and Drug Administration to bring this breakthrough treatment to patients as soon as possible," said Joshua D. Schein, Ph.D. Lev's chief executive officer.
Earlier this year, Lev filed a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for regulatory approval of Cinryze. The FDA has accepted the company's BLA filing and designated the submission for priority review, which targets an FDA action by January 30, 2008. Priority review status is granted by the FDA to products that, if approved, would be a significant improvement over existing therapies.
To date over 3,500 doses of Cinryze have been administered with an adverse event profile no different from placebo.
About Hereditary Angioedema
HAE is a genetic disorder caused by a deficiency of C1 inhibitor, a circulating plasma protein. This condition is the result of a defect in the gene controlling the synthesis of C1 inhibitor. C1 inhibitor maintains the natural regulation of the contact, complement, and fibrinolytic systems, that when left unrestricted, can initiate or perpetuate an attack by consuming the already low levels of endogenous C1 inhibitor in HAE patients. Patients with C1 inhibitor deficiency experience recurrent, unpredictable, debilitating, and potentially life threatening attacks of inflammation affecting the larynx, abdomen, face, extremities and urogenital tract.
While there is no approved therapy for acute HAE attacks in the U.S., C1 inhibitor has been used in Europe to treat HAE for more than 30 years. There are estimated to be 10,000 people with HAE in the United States.
For more information on HAE, visit the U.S. HAE Association's website at: www.haea.org.
About Lev Pharmaceuticals, Inc.
Lev is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. Lev's C1 inhibitor, proposed to be marketed as Cinryze, has been granted orphan drug status for the treatment and prevention of HAE, potentially securing, upon approval, market exclusivity for seven years. Lev has also received fast track designation status from the FDA, which facilitates the development and expedites the review of drugs and biologics intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs. Lev is also evaluating the development of C1 inhibitor for the treatment of acute myocardial infarction, or heart attack, and selective other diseases and disorders in which inflammation is known or believed to play an underlying role.