Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage biopharmaceutical company, announced today the initiation of a Phase Ib clinical trial to study the safety and efficacy of RX-3117 in cancer patients with solid tumors.
RX-3117 is a next-generation cancer cell specific drug candidate that possesses a broad spectrum of anticancer activity with reduced side effects. In an exploratory Phase I clinical trial conducted in Europe, RX-3117 demonstrated oral bioavailability, and safety and tolerability in cancer patients with solid tumors. The compound has also shown efficacy in human cancer cell lines resistant to gemcitabine (one of the most widely used chemotherapy drugs on the market today). Resistance to the anti-cancer effects of gemcitabine represents a major clinical issue in the treatment of cancer patients, as it has been estimated that up to 25% of cancer patients receiving one or more cycles of gemcitabine rapidly become resistant to its anti-cancer activity.
The Phase Ib trial is a multi-center dose-escalation study which will evaluate the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) of RX-3117 in patients with solid tumors. Secondary endpoints will include characterizing the pharmacokinetic profile of RX-3117 and evaluating the preliminary anti-tumor effects of RX-3117.
The trial is expected to enroll up to 30 patients from multiple sites in the United States. Patients will receive RX-3117 orally 3 times a week for 3 weeks followed by 1 week off, and will have the ability to continue on the drug for up to 8 cycles of treatment. The decision to enroll the next group of patients and escalate the dose will be made after 1 cycle of treatment, based on safety and tolerability. Patients will be assessed for tumor progression by CT or MRI prior to the start of therapy and after every 2 cycles of therapy. Rexahn expects to complete enrollment of patients by the end of 2014, and data is expected in the first half of 2015.
"The initiation of this Phase I clinical trial of RX-3117 represents an important milestone for Rexahn," added Peter D. Suzdak, Ph.D., Rexahn's Chief Executive Officer. "This compound is exciting to work with, as it has a unique profile with demonstrated activity against gemcitabine-resistant human cancer cells. We were pleased to see reduced side effect liability and oral bioavailability in cancer patients in our initial exploratory Phase I clinical trial conducted in Europe, and we believe that RX-3117 may represent a significant advancement in the treatment of cancer patients with solid tumors."
Dr. Drew Rasco, MD, Clinical Investigator, South Texas Accelerated Research Therapeutics in San Antonio, TX commented, "Gemcitabine resistance represents a major problem in the treatment of cancer patients with solid tumors. RX-3117 represents a very interesting new approach for the treatment of cancer patients with solid tumors who have become resistant to gemcitabine."
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