Navigation Links
Lev Pharmaceuticals Completes Phase III Prophylaxis Trial of,C1-Esterase Inhibitor for Hereditary Angioedema

NEW YORK, May 31, 2007 /PRNewswire-FirstCall/ -- Lev Pharmaceuticals, Inc. ("Lev" or the "Company") announced today that it has completed patient treatment in the prophylactic portion of its Phase III clinical trial of C1-esterase inhibitor (C1-INH) for hereditary angioedema (HAE). The clinical trial, designated CHANGE, examined and evaluated the efficacy and safety of C1-INH replacement therapy in treating acute HAE attacks and as prophylactic treatment to prevent HAE attacks.

Lev previously announced that its protocol-defined primary endpoint was achieved for the acute portion of the CHANGE study. The results indicated a clinically and statistically significant reduction in the time to sustained relief of acute HAE symptoms. HAE, or hereditary C1-inhibitor deficiency, is a rare and life-threatening inflammatory condition for which there is currently no FDA-licensed acute therapy in the United States.

"We are pleased to complete the prophylactic portion of the study ahead of schedule. The rapid enrollment and commitment of patients in the study reflects the need for an effective and safe prophylactic treatment for HAE," said Jason Bablak, the Company's Vice President, Regulatory Affairs and Product Development. "As the only company with a clinical development program for HAE prophylaxis, we look forward to expanding the treatment options for HAE patients."

The prophylactic segment of the CHANGE study was a placebo-controlled, double-blind, multi-center, crossover trial designed to determine the efficacy of C1-INH in preventing the onset of HAE attacks. In the study, 24 patients were randomly assigned to one of two treatment groups: C1-INH followed by placebo or placebo followed by C1-INH. Each patient received twice-weekly treatment with C1-INH for a 12-week period and twice-weekly treatment with placebo for a 12-week period. The final results of the prophylactic study are expected to be a vailable in the second half of 2007 after the data have been collected, verified and analyzed. In addition to the pivotal CHANGE trial, Lev has initiated two open-label studies to provide HAE patients with continued access to C1-INH.

Lev intends to submit a Biologics License Application, or BLA, to the U.S. Food and Drug Administration, or FDA, during the second quarter of 2007 for marketing approval of C1-INH for the acute treatment of HAE attacks based on the results of the first portion of the CHANGE study. The results from the prophylactic portion of the study, when available and if supportive, are expected to be used to expand the label indication.

About Hereditary Angioedema

HAE is a genetic disorder characterized by recurrent attacks of inflammation affecting the extremities (the hands and feet), the face, the abdomen, and the larynx. The inflammation can be disfiguring, debilitating, or, in the case of laryngeal attacks, life-threatening. HAE is caused by a deficiency of the plasma protein C1-INH. While there is no approved therapy for the condition in the U.S., replacement therapy with C1-INH is the treatment of choice for HAE in Europe, where it has been used safely and effectively for over 30 years. There are estimated to be approximately 10,000 people with HAE in the U.S.

About Lev Pharmaceuticals, Inc.

Lev is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. The Company is also evaluating the development of 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. Lev's C1-INH has been granted orphan drug status for the treatment and prevention of HAE, potentially securing, upon approval, market exclusivity for seven years. The Company has also received fast track designation status from the FDA, which facil itates 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.

Patients and physicians interested in obtaining more information about Lev's studies for hereditary angioedema should contact the Company directly at 212-682-3096, or visit the Company's website at http://www.levpharma.com.

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'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 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 will not obtain approval to market its products, the risk that Lev's products will not gain market acceptance, the risks associated with dependence upon key personnel and the need for additional financing.

CONTACT: Jason Tuthill, Director, Investor Relations, Lev Pharmaceuticals,Inc., +1-212-850-9130, jtuthill@levpharma.com

Web site: http://www.levpharma.com/

Ticker Symbol: (NASDAQ-OTCBB:LEVP)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights r eserved.
A United Business Media Company


'"/>




Related medicine technology :

1. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
2. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
3. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
4. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
5. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
6. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
7. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
8. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
9. Portola Pharmaceuticals Announces Positive Phase II EXPERT Results and Additional Oral and Poster Presentations at the XXI Congress of the International Society on Thrombosis and Haemostasis (ISTH)
10. Cyclacel Pharmaceuticals Announces Results of Phase II Seliciclib Combination Studies
11. Arisaph Pharmaceuticals Announces Results of its Potent Smart DPP-4 Inhibitor, ARI-2243, at the ADA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/9/2017)... 9, 2017 Zimmer Biomet Holdings, Inc. (NYSE ... today announced it has earned a spot on ... The Company was ranked among 500 U.S. employers as ... Healthcare Equipment and Services. The annual ... anonymous, independent survey of over 30,000 employees across 25 ...
(Date:5/9/2017)... 2017  Semler Scientific, Inc. (OTCQB: SMLR), an ... improve the clinical effectiveness and efficiency of healthcare ... quarter ended March 31, 2017. ... to identify when preventive care options are appropriate, ... heart attacks or strokes occur," said Doug ...
(Date:5/6/2017)... , May 5, 2017   Provista , a proven ... than 200,000 customers, today announced Jim Cunniff as ... of executive and business experience to Provista, including most recently ... in California . He assumed his new ... is a great fit for Provista," says Jody Hatcher ...
Breaking Medicine Technology:
(Date:5/26/2017)... ... 2017 , ... After raising nearly $30,000 on Kickstarter , about three-times ... at a discounted crowdfunding price on Indiegogo . , “Along with creating an ... to bring a fidget toy to the market that was made of superior quality ...
(Date:5/26/2017)... ... May 26, 2017 , ... “When the Stars Lead Home”: a poignant ... of published author Laura Weigel Douglas, an avid reader who lives in the Pacific ... sometimes feels like Green Hills Adventure Camp. She couldn’t be more grateful. , Twelve-year ...
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... Water damage ... Lee, New Jersey School District had left education officials with a number of critical ... replacement of the flooring had to be accomplished with little or no disruption to ...
(Date:5/24/2017)... ... 24, 2017 , ... NucleusHealth ™, advancing clinical practice ... Food and Drug Administration (FDA) 510(k) clearance for its Nucleus.io ... for medical image management. At the core is patented streaming technology that provides ...
(Date:5/24/2017)... ... May 24, 2017 , ... Myers Jackson is well ... the ability to sell luxury homes anywhere on the planet. The luxury home market ... from Hattiesburg to Houston city-scapes. A quick search of “11 Spyglass Hill Auction will ...
Breaking Medicine News(10 mins):