OXGN a possible short ?
80% jump might be an overreaction to this :
WATERTOWN, Mass.--(BUSINESS WIRE)--June 4, 2003-- OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN) announced today that the U.S. Food and Drug Administration (FDA) has granted "fast track" designation to the Company's lead tumor-starving compound, Combretastatin A4 Prodrug (CA4P), for the treatment of advanced anaplastic thyroid cancer (ATC). CA4P currently is being evaluated in a Phase II study of patients with this disease.
"The fast track designation represents a major regulatory accomplishment in our strategy to advance CA4P through the clinical trial process as rapidly as possible in anaplastic thyroid cancer," said OXiGENE President and Chief Executive Officer Fred Driscoll. "The FDA's decision reflects the urgent and unmet need for therapies to treat ATC, and validates the potential of our development plan to address the disease. This designation creates opportunities to meet with the FDA on an expedited basis to review our plan and receive ongoing input from the Agency into the design of clinical efficacy studies needed to support market approval."
The FDA's fast track program is intended to facilitate the development and expedite the review of new drugs intended to treat life-threatening conditions for which there is no approved therapy. The fast track designation applies to the combination of the drug candidate and a specific disease indication.
OXiGENE chose to pursue advanced-stage clinical development of CA4P for ATC after evaluating the results of Phase I safety studies of the compound. In one trial, an ATC patient was deemed a complete responder to treatment with CA4P. This patient completed treatment in October 1999 and has been cancer free since. Four additional Phase I patients with other forms of thyroid cancer experienced periods of prolonged disease stabilization following CA4P treatments.
An estimated 22,000 new cases of thyroid cancer are expected to be diagnosed in the U.S. in 2003. ATC is the rarest and deadliest of the four main forms of the disease.
Clinicians at the Ireland Cancer Center at University Hospitals of Cleveland (Case Western Reserve University) are studying the effects of CA4P in patients with ATC. A key objective of this Phase II trial is to determine whether CA4P can extend to 12 months the median survival of patients with regionally advanced or metastatic ATC. The current life expectancy of those patients is four to six months.
In addition to requesting the fast track designation, OXiGENE has asked the FDA to award CA4P Orphan Drug Status for the treatment of ATC. The first sponsor to obtain market approval for an orphan drug-designated product is guaranteed seven years of market exclusivity, tax credits and other benefits.
CA4P, the water-soluble prodrug of Combretastatin A4, a compound isolated from the African bush willow Combretum Caffrum, is designed to damage and destroy solid tumors by choking off the flow of blood that enables them to grow and thrive. Research in animal models has shown that CA4P works by rapidly and selectively disrupting the function of the immature endothelial cells that line the vascular network of tumors...
Or is it one of those stocks like ARIA that are best left well alone ? |
