|Onxigene'sTrial of ZYBRESTAT Achieved Primary Efficacy Endpoint; Rexahn Announces Initial Results from Phase I Trial of Supinoxin™ (RX-5902)|
|By Staff and Wire Reports|
|Tuesday, 11 March 2014 19:13|
OXiGENE, Inc. (Nasdaq: OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, today announced positive results from a randomized Phase 2 clinical trial evaluating Avastin® (bevacizumab) with or without ZYBRESTAT® (fosbretabulin; CA4P) to treat patients with recurrent ovarian cancer. The study, known as Gynecologic Oncology Group protocol 186I, met its primary endpoint of a statistically significant increase in progression-free survival (p < 0.05; hazard ratio 0.685) for the combination as compared to bevacizumab alone.
The Phase 2 study is being conducted by the GOG under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). It is the first and currently only randomized trial to test an antiangiogenic therapeutic agent combined with a vascular disrupting agent, without including any cytotoxic chemotherapy.
"These findings validate both the novel approach and the complementary mechanisms of combining the vascular disrupting agent fosbretabulin and an antiangiogenic agent like bevacizumab in patients with ovarian cancer," said Bradley J. Monk, M.D., FACS, FACOG, principal investigator for the trial, and professor and director, Division of Gynecologic Oncology and Department of Obstetrics and Gynecology at the University of Arizona Cancer Center. "This promising combination warrants further evaluation particularly given the significant need for new treatment options in relapsed ovarian cancer."
As previously reported, the GOG protocol 186I enrolled 107 patients with platinum-sensitive and -resistant recurrent ovarian cancer at 67 clinical sites in the U.S. Patients were randomized 1:1 into one of two treatment arms: one arm received Avastin, and the second arm received Avastin plus ZYBRESTAT. Both therapies were administered intravenously every three weeks and patients were treated until disease progression or until adverse effects prohibited further therapy.
Secondary endpoints in the study include safety, objective response rate (measured according to RECIST criteria) and overall survival. Patients receiving the combination of ZYBRESTAT and Avastin achieved a higher objective response rate, which was not statistically significant. All patients will continue to be followed for overall survival. Consistent with prior clinical experience with ZYBRESTAT, patients in the combination arm experienced a higher incidence of hypertension compared to the control arm. All cases of hypertension were managed with antihypertensive treatments, as specified in the study protocol. It is expected that the full study results will be submitted for presentation at a future scientific meeting.
For this study, ZYBRESTAT is provided to CTEP under a Cooperative Research and Development Agreement (CRADA) with OXiGENE and bevacizumab is being provided as an investigational agent under a CRADA with Genentech. Bevacizumab is not approved to treat women with ovarian cancer in the U.S.; however, it is approved in other countries for treatment of ovarian cancer.
"We are very excited about these positive results and greatly appreciate all the patients who enrolled in this study and the support, resources and commitment of GOG and CTEP to conduct this important program," said Peter Langecker, M.D., Ph.D., chief executive officer of OXiGENE. "ZYBRESTAT is the first vascular disrupting agent to show a statistically significant progression-free survival benefit, and we are evaluating next steps to advance this combination to patients in need."
Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage biopharmaceutical company announced today initial data for the Phase I dose-escalation clinical trial of Supinoxin™ (RX-5902) initiated in August 2013. This trial was designed to study safety and efficacy in patients with solid cancer tumors.
The study is still ongoing and the maximal tolerated dose (MTD) has not yet been achieved. Three dosing cycles have been completed (25, 50 and 100 mg) and no drug related adverse events have been reported. The fourth dosing cycle (150 mg) has been initiated. Two patients have received 2 cycles of treatment and one patient has received 6 cycles of treatment. Pharmacokinetic analysis has shown that Supinoxin™ displays dose-proportional exposure and an estimated oral bioavailability of 51%. The pharmacokinetic profile of Supinoxin is similar to what has been seen in preclinical studies.
Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer commented, “We are encouraged that Supinoxin is safe and well-tolerated over the dose range tested in cancer patients with solid tumors who have received multiple cycles of treatment. In addition, the pharmacokinetic profile and oral bioavailability of Supinoxin is consistent with preclinical studies. These data are very encouraging, and we look forward to sharing additional data from the trial when it is completed later this year.”
The Phase I trial of Supinoxin, which was initiated in August 2013, is a dose-escalation study which will evaluate the safety, tolerability, dose-limiting toxicities and MTD in patients with solid cancer tumors that have previously failed treatment with approved therapies and shown progression of disease. Secondary endpoints include pharmacokinetic analysis and evaluating the preliminary anti-tumor effects of Supinoxin. This trial is being conducted in three clinical oncology centers in the United States. Each patient has the ability to continue on the drug up to six cycles of treatment (a dosing cycle is defined as 3 weeks of drug treatment followed by and 1 week off) if no disease progression is seen. Patients are assessed by CT or MRI prior to the start of therapy and after every two cycles of therapy to assess tumor progression. The trial is using an accelerated dose-escalation design: one patient is treated per dose cycle until a grade 2 related adverse event occurs then three patients will be treated per dose cycle. The decision to escalate dose is made by the DMSB after completion of one cycle of treatment based on safety and tolerability. Patients have the possibility to receive up to 6 cycles of treatment if the disease does not progress. Tumor biopsy samples are taken to assess the biomarker phospho-P68.
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OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, today announced positive results from a randomized Phase 2 clinical trial evaluating Avastin® (bevacizumab) with or without ZYBRESTAT® (fosbretabulin; CA4P) to treat patients with recurrent ovarian cancer.
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