OXiGENE's Lead Drug Candidate CA4P Demonstrates Anti-tumor Activity in Radiation Therapy-based Treatments.
OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN) announced today that new data demonstrating anti-tumor activity of the Company's lead drug candidate, CA4P, in combination with radiotherapy, will be presented at the European Society for Therapeutic Radiology and Oncology (ESTRO) meeting in Amsterdam held October 24th through the 28th.
Professor Peter Hoskin, a clinical oncologist at the Mount Vernon Hospital in the United Kingdom, will present data from the ongoing Phase Ib clinical trial of CA4P in combination with radiotherapy in patients with inoperable non-small cell lung cancer (NSCLC). Professor Hoskin's data shows that in eight patients, significant reductions in relative tumor blood volume were observed at four hours after treatment with no tumor blood volume recovery even at 72 hours, as measured by dynamic contrast-enhanced computed tomography (CT).
"We are encouraged by both the tumor blood-flow reduction and the absence of any enhanced normal tissue damage from radiation seen in our ongoing trial of CA4P in combination with radiotherapy," said Professor Hoskin. "Even at this early stage, we are optimistic about this treatment since we have seen significant evidence of blood volume reduction and evidence of anti-tumor activity. Now that the NSCLC patient kohorts are completed, we are moving forward to enroll and treat the remaining patients with prostate and head & neck cancers for this Phase Ib study through early next year. We also anticipate advancing towards a Phase II randomized trial in conjunction with OXiGENE."
"This new data on the combination of CA4P and radiotherapy shows promising biological response and anti-tumor effects," said Dr. Dai Chaplin, Chief Scientific Officer for OXiGENE. "It is particularly encouraging that prolonged shutdown in blood flow has been observed in the clinic since in pre-clinical animal models such blood flow reductions induced by CA4P post radiotherapy have been associated with enhanced treatment response."
In an invited talk, Dr. Michael Horsman of the Arhus University Hospital in Denmark will present pre-clinical data on CA4P in combination with radiotherapy in various animal tumor models. The results show a statistically significant anti-tumor response due to this therapy combination. In addition, the CA4P/radiotherapy combination did not enhance the effects of radiation therapy in any normal animal tissue studied to date. "It is very encouraging to see that significant enhancement of radiation response can be achieved in tumors without enhancing normal tissue damage," said Horsman.
About Combretastatin A4P (CA4P)
CA4P leads a novel class of drug candidates called vascular targeting agents (VTAs). CA4P attacks the vascular structure of solid tumors and other diseases characterized by the formation of aberrant blood vessels. The compound triggers a change in the shape of the endothelial cells lining these blood vessels in turn, blocking the flow of blood to a tumor and depriving it of oxygen and nutrients essential to its survival. Similarly, in eye diseases that are characterized by abnormal blood vessel growth, CA4P appears to disrupt these vision impairing blood vessels.
CA4P is currently being studied in six clinical trials in oncology, including anaplastic thyroid, lung, head and neck, prostate, colorectal, ovarian and cervical cancers. It is also in a Phase I/II trial in wet age-related macular degeneration. These clinical trials involve the use of CA4P in both single-agent and multiple treatment modalities.
About OXiGENE, Inc.
OXiGENE is an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases. The Company's major focus is the clinical advancement of drug candidates that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property position and therapeutic development expertise to bring life saving and enhancing medicines to patients.
Safe Harbor Statement
Certain statements in this news release concerning OXiGENE's business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the effect of CA4P on OXiGENE's drug development opportunities, the timing of Phase II trials and the ability of CA4P to have potent anti-tumor effects. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; the ability to secure necessary patents; uncertainties as to the future success of ongoing and planned clinical trials; and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. None of OXiGENE's products under development have been approved for marketing by the FDA. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements are contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's 10-Q, 8-K and 10-K reports. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
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|Date:||Oct 25, 2004|
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