OxiGENE starts trial that pairs CA4P vascular-disrupting compound with Genentech's Avastin

By E. Janene Geiss

Philadelphia, Dec. 5 - OxiGENE, Inc. announced Monday that it will begin a new clinical trial with its lead vascular-disrupting compound, Combretastatin A4 Phosphate (CA4P).

The company said it will start a phase Ib clinical study to evaluate CA4P in combination therapy with Avastin (bevacizumab), a drug that is owned and marketed by Genentech, according to a company news release.

The phase Ib clinical trial follows previously announced preclinical data presented at a recent conference of the American Association for Cancer Research that showed the combination of CA4P with the anti-angiogenic drug Avastin produced significant anti-tumor activity and could offer a powerful and highly targeted treatment strategy for fighting solid tumors.

Officials said this will be the first human clinical trial to pair a vascular-disrupting compound and an anti-angiogenic agent in the treatment of cancer, specifically in people who have failed previous treatment and who are in advanced stages of disease.

The trial makes OxiGENE the first developer of vascular-disrupting agents to pair a small molecule with chemotherapy, radiotherapy and now, anti-angiogenic therapy, officials said.

"Preclinical models continue to support the theory that the combination of compounds targeted toward tumor vasculature could have a profound anti-tumor effect in humans," David Chaplin, chief scientific officer and head of research and development, said in the release. "In addition, we believe the complementary action of a [vascular-disrupting agent] with anti-angiogenic approaches may have utility not only in cancer, but in other diseases where abnormal new vessel growth underlies the disease pathology."

In recent preclinical studies examining efficacy of Avastin with CA4P in a human renal cell carcinoma model, CA4P was shown to enhance the effect of Avastin, officials said.

The data showed that treatment with Avastin or CA4P alone resulted in tumor growth delays of eight days and six days, respectively. The data also showed that CA4P was effective at causing extensive vasculature damage and tumor cell death in the central regions of solid tumors.

But when CA4P was administered in combination with Avastin, statistically significant, enhanced anti-tumor effects were observed. The combination of CA4P plus Avastin led to a tumor growth delay of 13 days - an increase of about 61% in the effectiveness of Avastin, officials said.

The Food and Drug Administration approved Avastin in February 2004 for use in combination with intravenous 5-Fluorouracil-based chemotherapy as a treatment for patients with certain cancers of the colon and rectum. Other phase 3 clinical trials are underway.

OxiGENE's phase 1b combination trial with Avastin will be a traditional open-label, multi-center trial designed to determine the safety and tolerability of ascending doses of CA4P administered intravenously in combination with bevacizumab. Pharmacodynamic effects to assess blood flow shutdown to the tumor will be assessed with MRI imaging.

OxiGENE is Waltham, Mass., developer of biopharmaceutical compounds designed to treat cancer and certain ophthalmologic diseases.

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