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New cancer combo therapy results positive:OXiGENE



25 August, 2005: OXiGENE, Inc., has presented updated clinical trial data for its lead vascular disruption agent, Combretastatin A4 Prodrug (CA4P). 

The leading developer of biopharmaceutical compounds to treat cancer and certain ophthalmologic diseases presented the data at the 9th International Workshop on the Tumour Microenvironment Meeting being held at Christ Church College in Oxford, United Kingdom.

Gordon Rustin, Director of Medical Oncology at Mount Vernon Cancer Centre in the United Kingdom, presented a paper entitled, A phase Ib trial of Combretastatin A-4 Phosphate (CA4P) in Combination with Carboplatin or Paclitaxel Chemotherapy in Patients with Advanced Cancer. Dr. Rustin first presented interim data of this study at the May 2005 American Society of Clinical Oncology Annual Meeting. In his presentation today, Dr. Rustin provided additional new clinical data and noted that a total of 41 patients have been enrolled in the combination study. 
He mentioned that the trial has most recently entered the final stage in which the triple combination of CA4P/Carboplatin/Taxol is being administered consecutively, and he reported that the drug appears to be well tolerated and that no drug-related, serious adverse events occurred. The most common side effects observed are headache, fatigue and transient hyper- or hypotension, but no cardiac toxicity.

In addition, tumor response as defined according to RECIST or CA125 has been seen in 7 out of 12 evaluable patients with ovarian cancer. Partial responses have been seen in patients with small cell lung cancer and esophageal cancer, and disease stabilization was seen in a patient with rapidly progressing renal papillary cancer.

"When taken in the aggregate, positive anti-tumor effects in this trial have been demonstrated using CA4P in combination with either carboplatin or paclitaxel in patients with various tumor types with no unexpected toxicities above those typically anticipated from carboplatin or paclitaxel alone--even at a high dose level of CA4P. Additionally, we have not experienced any cardiac toxicity with patients, nor have we reached any dose-limiting toxicity. Surprisingly, little myelosuppression has been seen at a dose of CA4P at 54 mg/m2 or CA4P at 63 mg/m2 administered 18 - 22 hours prior to carboplatin, paclitaxel or both drugs combined. Although it is too early to report definite response data with the triple combination, we are encouraged by early signs of anti-tumor activity achieved in this group of patients. Therefore, we remain on track for completing this trial soon and are optimistic about moving forward with a multi-center phase II study evaluating the efficacy of the triple combination therapy in platinum resistant ovarian patients," Dr Rustin commented on the trial data.

"This data presented by Dr. Rustin and his team are encouraging from both a safety and an anti-tumor response perspective," stated Frederick Driscoll, President and Chief Executive Officer at OXiGENE, Inc in a news release. This update in a significant number of patients indicates both the tolerability and efficacy of CA4P in combination trials with carboplatin and paclitaxel, one of the most widely-used chemotherapeutic regimens, he added. 

CA4P leads a novel class of drug candidates which have been referred to by OXiGENE as 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 has been shown in preclinical studies to suppress development and induce regression of these unnecessary blood vessels.

CA4P is currently being studied in seven clinical trials in oncology, including anaplastic thyroid, lung, head and neck, prostate, colorectal, ovarian, cervical cancers and other imageable tumor types. These clinical trials involve the use of CA4P in both single-agent and combination therapies. It is also currently being studied in a phase II trial in myopic macular degeneration.

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.



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