NEW YORK, Nov. 1 /PRNewswire-FirstCall/ -- Lev Pharmaceuticals, Inc. announced today the initiation of prophylaxis treatment as part of its ongoing Phase III clinical trial for the Company’s lead product candidate, C1-esterase inhibitor (“C1-INH”), for hereditary angioedema (“HAE”). The multi-center, placebo-controlled, double-blind study is designed to examine the efficacy and safety of C1-INH in preventing the onset of HAE attacks.
“I am delighted that Lev Pharma is developing C1-esterase inhibitor to treat HAE patients, and I am particularly excited that this therapy is being studied for its effectiveness in preventing HAE attacks,” said Martha V. White, M.D., Research Director at the Institute for Asthma and Allergy, Wheaton, Maryland, and an investigator in the study. “A prophylactic treatment would be a major breakthrough in the treatment of hereditary angioedema in the United States.”
Lev Pharmaceuticals initiated its Phase III trial of C1-INH in the first quarter of this year. The first part of the study, which is ongoing, is designed to examine the efficacy and safety of C1-INH in the treatment of acute attacks in HAE. The second part of the Phase III study is specifically examining the ability of C1-INH to prevent such inflammatory attacks.
“This is the only clinical trial underway, to our knowledge, for the development of a prophylactic treatment for this debilitating disease,” said Joshua Schein, Ph.D., Chief Executive Officer of Lev Pharmaceuticals. “The initiation of this prophylactic part of our Phase III study is a significant step toward bringing an effective therapeutic to the U.S. HAE patient population.”
In Europe, C1-esterase inhibitor therapeutics are currently used as replacement therapy for the treatment of HAE and are the treatment of choice for HAE attacks. Lev Pharmaceuticals intends to develop C1-INH in the United States for acute and prophylactic treatment of HAE. In 2004, the Company received orphan drug designation from the United States Food and Drug Administration for C1-esterase inhibitor (human) in treating hereditary angioedema. Upon product licensure, orphan drug designation could provide the Company with seven years of marketing exclusivity for its C1-INH product as a treatment for HAE in the United States.
Patients and physicians interested in obtaining more information about the Phase III trial should call Lev Pharmaceuticals at 212-682-3096, or visit the Company’s website at http://www.levpharma.com.
About Hereditary Angioedema
HAE is a genetic disorder characterized by episodes of edema (swelling) in the extremities (the hands and feet), the face, the abdomen, and the larynx. There are thought to be 6,000 or more people with HAE in the United States. The majority of patients experience episodes of severe abdominal pain, nausea, and vomiting that is caused by swelling in the intestinal wall. Attacks that involve the face and throat can result in closure of the airway passages, and the mortality rate from untreated airway obstruction has been reported to be over 30% with death most frequently caused by asphyxiation due to airway closure. HAE is caused by a deficiency of C1-INH, and there are currently no approved treatments for acute attacks available in the United States.
About Lev Pharmaceuticals, Inc.
Lev Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. Lev Pharmaceuticals’ product candidates are based on C1-esterase inhibitor (“C1-INH”), a human plasma protein that mediates inflammation and is potentially applicable as a treatment for a range of medical indications. In addition to the treatment of hereditary angioedema, Lev Pharmaceuticals is also developing C1-INH 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.
Legal notice to investors: Certain matters discussed in this news release are “forward-looking statements.” These forward-looking statements, which apply only on the date of this release, generally can be identified by the use of forward-looking terminology such as “may,” “will,” “expects,” “intends,” “estimates,” “anticipates,” “believes,” “continues” or words of similar import. Similarly, statements that describe Lev Pharmaceutical’s future plans, objectives or goals are also forward-looking statements, which generally involve known and unknown risks, uncertainties and other facts that may cause the actual results, performance or achievements of Lev Pharmaceuticals to be materially different from those expressed or implied by such forward-looking statements. Such factors may include the following: uncertainties associated with product development, the risk that Lev Pharmaceuticals will not obtain approval to market its products, the risk that Lev Pharmaceuticals’ products will not gain market acceptance, the risks associated with dependence upon key personnel and the need for additional financing.
Contacts: Joshua D. Schein, Ph.D. Chief Executive Officer Lev Pharmaceuticals, Inc. 212-682-3096 jschein@levpharma.com Sharon Weinstein Director of Investor Relations Noonan Russo 212-845-4271 sharon.weinstein@eurorscg.com
Lev Pharmaceuticals, Inc.
CONTACT: Joshua D. Schein, Ph.D., Chief Executive Officer of LevPharmaceuticals, Inc., +1-212-682-3096, jschein@levpharma.com; or SharonWeinstein, Director of Investor Relations of Noonan Russo, +1-212-845-4271,sharon.weinstein@eurorscg.com, for Lev Pharmaceuticals, Inc.
Web site: http://www.levpharma.com/
