OXiGENE Completes Patient Enrollment in a Phase II Clinical Trial Evaluating CA4P with Chemotherapy in Imageable Solid Tumors
Thursday March 23, 8:30 am ET
With Individuals Still Receiving Therapy, Company Anticipates Presentation of Data Later in 2006
biz.yahoo.com
WALTHAM, Mass.--(BUSINESS WIRE)--March 23, 2006--OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a leading developer of biopharmaceutical compounds designed to treat cancer and certain ophthalmologic diseases, today announced that the Company has successfully completed patient enrollment in a Phase II clinical trial for the treatment of imageable solid tumors. The trial, which is being conducted in the United States under OXiGENE's Investigational New Drug (IND) application on file with the Food and Drug Administration, is designed to evaluate the safety and anti-cancer activity of the triple combination of Combretastatin A4P (CA4P)--OXiGENE's lead therapeutic candidate--together with widely-used chemotherapy agents, carboplatin and paclitaxel. OXiGENE expects the presentation of top line data later in 2006, as patients enrolled in this trial are continuing to receive prolonged therapy.
"We believe that the completion of patient accrual in this Phase II clinical trial is another significant milestone in the clinical advancement of Combretastatin A4P," commented Frederick Driscoll, President and Chief Executive Officer at OXiGENE. "We continue to be encouraged by the safety profile to date of the combination of CA4P and chemotherapy, as well as by the patient benefit that has been observed in early safety trials."
The Phase II clinical trial, which received clearance to commence in December 2004, is a randomized, open-label trial designed to evaluate the triple combination of Combretastatin A4P, carboplatin and paclitaxel in patients with solid tumors. The objectives of the trial are to assess the safety of several doses of CA4P in combination with the two chemotherapeutic agents, gather data on anti-tumor activity and establish a recommended Phase II/III dose. Additionally, the study will assess, by Magnetic Resonance Imaging (MRI), changes in tumor blood flow, which may provide additional insight into the biological activity of CA4P.
An Overview of the Clinical Advancement of CA4P plus Chemotherapy
After completing several early safety trials with CA4P as a monotherapy, as well as preclinical studies in animals showing synergistic effects when CA4P was paired with carboplatin, OXiGENE completed a Phase Ib clinical trial to evaluate the safety and tolerability in man of the CA4P-carboplatin combination.
This first combination trial led to the commencement of a Phase I/II clinical trial (at centers in the United Kingdom and the United States) to evaluate the pairing of CA4P with carboplatin or paclitaxel or both chemotherapeutic agents combined. The trial, which is now closed for patient enrollment, was designed to establish the optimal dose and the maximum tolerated dose, to recommend a Phase II dose, and to assess the safety and tolerability of the combination in patients with ovarian cancer, as well as other solid tumors.
Based on the presentation of positive interim data by the investigators leading this Phase I/II trial, OXiGENE, in December 2004 and ahead of its anticipated clinical timeline, initiated a randomized, open-label Phase II clinical trial in the United States to evaluate the therapeutic combination in imageable solid tumors. This trial has now completed patient enrollment, but patients are still receiving therapy.
During 2005, investigators provided several positive interim updates to the Phase I/II combination trial; data which supported OXiGENE's decision to progress with the above-mentioned Phase II clinical trial in imageable tumors. Most recently, in November 2005 at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics, investigators presented data that indicated a 67 per cent response rate among evaluable patients with advanced, inoperable ovarian cancer who were treated with the combination of CA4P and chemotherapy. All of these patients had failed previous, alternate cancer treatments. The investigator also reported that four additional ovarian cancer patients had disease stabilization during treatment, and partial responses were seen in patients with esophageal cancer and small cell lung cancer.
This interim update again reinforced OXiGENE's strategic decision to initiate a Phase II clinical trial, ahead of schedule, evaluating CA4P in combination therapy with carboplatin and paclitaxel for the treatment of relapsed, advanced platinum-resistant ovarian cancer. This trial is currently underway.
About Combretastatin A4P (CA4P)
CA4P leads a novel class of small-molecule drug candidates called vascular disrupting agents (VDAs). CA4P works via two potentially synergistic processes that selectively target pericyte-depleted neovessels, which lack ensheathment from smooth muscle support cells. CA4P is a potent and reversible tubulin depolymerizing agent that causes newly formed endothelial cells that line blood vessels to change shape, round up and detach from the vessel wall. Recent preclinical research has also shown that CA4P disrupts the molecular engagement of VE-cadherin, a junction protein important for endothelial cell survival and function, and inhibits the associated (beta)-catenin/AKT signaling pathway, leading to rapid vascular collapse and tumor cell death, or necrosis. These complementary mechanisms block the flow of blood to a tumor and deprive 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. |
