Hyseq Pharmaceuticals Initiates Phase I Trial for Lead Product Candidate Alfimeprase
SUNNYVALE, Calif., July 1 /PRNewswire-FirstCall/ -- Hyseq Pharmaceuticals, Inc. (Nasdaq: HYSQ - News), today announced the initiation of a Phase I clinical trial of its novel acting thrombolytic, alfimeprase, in patients with peripheral arterial occlusion (PAO).
The multi-center, open-label, dose-escalation study to evaluate alfimeprase's safety and pharmacokinetics, will be conducted in twenty patients across six centers in the United States.
"Alfimeprase is a more direct thrombolytic, both in its mechanism of action and its method of delivery than traditional plasminogen activators or currently available drugs in this class," said Dr. Ted W. Love, president and chief executive officer of Hyseq Pharmaceuticals. "As a result, alfimeprase has the potential to represent a major new advance in the treatment of vascular disease."
Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot. Compared to traditional plasminogen activators, pre-clinical studies have shown alfimeprase to be up to six times faster in dissolving clots. In addition, alfimeprase's novel clearance mechanism dramatically limits the molecule's half-life, reducing the risk of bleeding complications, a common side-effect of current therapies.
Bypass surgery and angioplasty are established treatments for PAO, however treatment with thrombolytic drugs has presented a less-invasive and more cost-effective alternative. There are currently no products on the market approved to treat PAO. With the limited treatment options currently available, alfimeprase has received Orphan Drug designation for the PAO indication.
"PAO of the lower extremity is a significant cause of morbidity and amputation in the United States with over 100,000 cases reported annually," said Dr. Kenneth Ouriel, chairman of the department of vascular surgery at the Cleveland Clinic and the principal investigator for the study. "Pre-clinical studies indicate that alfimeprase is a promising agent for dissolving clots and may be particularly well suited for the PAO indication, an indication which is currently extremely limited in treatment options."
Alfimeprase was identified through Amgen's research program and partnered with Hyseq in January 2002 for development and commercialization. Under the terms of the collaboration, Hyseq will lead development and be responsible for all clinical development activities and Amgen will be responsible for manufacturing activities. Amgen will have the option to lead the commercialization efforts in which both companies may participate.
"This is a very important milestone for us," said Dr. Ted W. Love, president and chief executive officer of Hyseq Pharmaceuticals. "Last year we began to transition Hyseq to a fully integrated biopharmaceutical company and we have made great strides in this direction. The initiation of clinical trials for our first product candidate is an excellent example of Hyseq's ability to execute efficiently while continuing to bring value to its shareholders."
About PAO
PAO is the blocking of arterial blood flow to a distant part of the body by a clot. PAO usually occurs in the leg and is the result of underlying peripheral arterial disease (PAD), in which chronic fatty plaque buildup restricts blood flow. The classic early symptom of PAO is leg pain or fatigue during activity that subsides with rest. Continued restriction of blood flow leads to pain at rest and, if the ischemia continues, to ulcers, gangrene, tissue death and if untreated, foot or leg amputation.
Upcoming Events
Hyseq will hold its annual shareholder's meeting on Tuesday August 6, 2002 at 11:00 a.m. (Pacific Time) at 675 Almanor Avenue, Sunnyvale, CA 94085.
About Hyseq
Hyseq Pharmaceuticals, Inc. is engaged in research and development of novel biopharmaceutical products from its collection of proprietary genes discovered using its high-throughput screening-by-hybridization platform. Hyseq's screening-by-hybridization platform provided a significant advantage in discovering novel, rarely-expressed genes, and assembly of one of the most important proprietary databases of full-length human gene sequences. Hyseq is expanding and accelerating its research activities to further elucidate the role of novel genes in its proprietary database. Hyseq's database includes genes which encode a number of therapeutically important classes of molecules including chemokines, growth factors, stem cell factors, interferons, integrins, proteases, hormones, receptors, and other potential protein therapeutics or drug targets.
Information about Hyseq Pharmaceuticals is available at www.hyseq.com or by phoning 408-524-8100.
Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to unanticipated difficulties and delays relating to gene identification, drug discovery and clinical development processes; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in our periodic reports filed from time to time with the SEC, including without limitation our Annual Report on Form 10-K for the year ended December 31, 2001. We disclaim any intent or obligation to update these forward-looking statements.
SOURCE: Hyseq Pharmaceuticals, Inc. |
