We would like to highlight Dyax Corp. (NASDAQ: DYAX). The company is a clinical stage biotechnology company focused on the discovery, development and commercialization of biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications. Dyax uses the drug discovery technology, known as phage display, to identify antibody, small protein and peptide compounds for clinical development.
In the company’s news yesterday,
Dyax Corp. announced positive topline results from its second phase-3, placebo-controlled trial, EDEMA4, for its lead product candidate DX-88 (ecallantide) for hereditary angioedema (HAE), or the rapid swelling of the skin.
The trial utilized the participation of 96 patients and was conducted at 42 sites in the United States and Canada. The company’s anticipated goal was to determine the efficacy and safety of a fixed 30 mg. subcutaneous dose of DX-88 in the treatment of moderate to severe acute HAE attacks.
The EDEMA4 trial was conducted under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA) and marked significant improvements in the intent-to-treat population in primary and secondary endpoints. The trial was consistent with outcomes of the first phase 3 placebo-controlled trial (EDEMA3) for HAE.
“The positive results from our EDEMA4 and EDEMA3 trials support the potential of DX-88 as an important acute therapy for HAE patients. Moreover, DX-88’s profile as a recombinant, subcutaneous therapy, may offer treatment advantages to patients suffering from this debilitating and life-threatening disease,” William E. Pullman, M.D., Ph.D., FRACP, executive vice president and chief development officer of Dyax stated in the press release.
Based on the safety and efficacy results from the two trials, Dyax plans on submitting the last module of its Biologics License Application (BLA) to the FDA early in the fourth quarter of 2008.
“We are extremely pleased that the EDEMA4 results validate the promise of DX-88 as a potential treatment solution for the HAE community,” Henry E. Blair, chairman, president and CEO stated. “The DX-88 BLA will include the most extensive placebo-controlled assessment of any therapy for the treatment of HAE and was based on a Dyax-developed comprehensive endpoint evaluation. We look forward to submitting our BLA and, ultimately, commercializing this innovative therapy.”
About QualityStocks
QualityStocks, based in Scottsdale, Arizona is a free service that collects data from hundreds Small-Cap and Micro-Cap online Investment Newsletters into one Free Daily Newsletter Report. QualityStocks is dedicated to assisting emerging public companies with their advertising efforts and now has over 500,000+ subscribers that receive The Daily Stock Newsletters.
To sign up for “The QualityStocks Daily Newsletter” please visit www.QualityStocks.net
Please see disclaimer on QualityStocks website: http://Disclaimer.QualityStocks.net
Forward-Looking Statement:
This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.
