|Rexahn Announces Additional Data from Preclinical Studies of RX-3117; Genzyme and Isis Receive Corporate Award from the NORD|
|By Staff and Wire Reports|
|Thursday, 08 May 2014 18:35|
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN) a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced additional data from preclinical studies on the anti-tumor effects of RX-3117, a next generation cancer cell specific nucleoside analog. In the study, oral administration of RX-3117 inhibited tumor growth in 12 different human cancer xenograft models including colon, non-small cell lung, small cell lung, pancreatic, renal, ovarian, and cervical cancer. In addition, RX-3117 inhibited the growth of human cancer cells lines shown to be resistant to the anti-cancer effects of gemcitabine, including in the primary low-passage human pancreatic tumorgraft model.
“Resistance to the anti-cancer effects of gemcitabine represents a major clinical issue in the treatment of cancer patients. Up to 25% of cancer patients receiving one or more cycles of gemcitabine rapidly become resistant to its anti-cancer activity. Based on study results to date, both preclinical and clinical, we believe RX-3117 holds the potential to be used for the treatment of tumors that do not respond to gemcitabine and other chemotherapeutic drugs,” commented Rexahn’s CEO, Peter D. Suzdak, Ph.D.
RX-3117 showed greater efficacy (tumor growth inhibition) as compared to gemcitabine in four different xenograft animal models with gemcitabine resistant human cancer cell lines: colorectal cancer (Colo205), small cell lung cancer (H69), cervical cancer (CaSki) and pancreatic cancer (CTG-0298).
Additionally, in a mouse xenograft model using human colorectal cancer cells, those treated with RX-3117 showed significantly longer survival as compared to those receiving other treatments. Mice treated with RX-3117 showed 100% survival through day 95 after initial treatment, compared to 13% of mice treated with gemcitabine, and 25% of mice treated with irinotecan, both FDA-approved drugs.
Results of these studies were presented in a poster titled, “A novel small molecule cytidine analog, RX-3117, shows potent efficacy in xenograft models, even in tumors that are resistant to treatment with gemcitabine,” at the American Association for Cancer Research (AACR) Annual Meeting 2014 on April 6, 2014.
Earlier this year, Rexahn initiated a Phase Ib trial for RX-3117. The trial is a multi-center dose-escalation study which is evaluating the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) of RX-3117 in patients with solid tumors. Secondary endpoints include characterizing the pharmacokinetic profile of RX-3117 and evaluating the preliminary anti-tumor effects of RX-3117.
In August 2012, Rexahn reported the completion of an exploratory Phase I clinical trial of RX-3117 in cancer patients conducted in Europe, to investigate the oral bioavailability, safety and tolerability of the compound. In this study, oral administration of RX-3117 demonstrated an oral bioavailability of 56% and a plasma half-life (T1/2) of 14 hours. In addition, RX-3117 was safe and well tolerated in all subjects throughout the dose range tested.
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (NASDAQ: ISIS), today announced that they have received the 2014 Partners in Progress Corporate Award from NORD in recognition of KYNAMRO® (mipomersen sodium) injection. KYNAMRO, selected for being a very important orphan therapy to reach the market in the United States, is an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
“There are over 7,000 rare diseases, of which, only 300 currently have a treatment option,” said NORD President and CEO Peter L. Saltonstall. “Each therapy brought to market for one rare disease provides hope to the many others that are still in need. We are pleased to recognize Genzyme and Isis for their dedication and commitment to improving the lives of patients with a rare disease.”
This award marks the third time that Genzyme has been recognized by NORD for its contributions and ongoing commitment to improving the lives of those affected by rare diseases. The award will be presented tonight at NORD’s "Portraits of Courage Celebration" in Washington, DC.
“It is an honor to be recognized by NORD and we hope this award serves to highlight the considerable unmet need that still exists in helping patients with rare diseases,” said Genzyme President and CEO, David Meeker, M.D. “We are proud that we are able to bring our rare disease expertise to patients living with HoFH, who have exhausted conventional medications and are still in need of additional treatment options.”
The NORD Gala is an annual event at which researchers and others are honored for improving the lives of people with rare diseases. Each year NORD honors organizations that have made a positive contribution to further the needs of the patient community, and have inspired the public to do so as well.
“KYNAMRO is the first systemic antisense drug to reach the market and is the culmination of two decades of work to create a new, more efficient drug technology platform,” said Stanley T. Crooke, M.D., Ph.D., Chairman of the Board and CEO of Isis. “We are incredibly grateful to NORD for its recognition of the work to bring this much needed therapy to patients living with HoFH.”
NORD is a nonprofit organization established in 1983 to represent all individuals and families affected by rare diseases. It provides advocacy, education, support for research, and patient assistance programs to improve the lives of the 30 million Americans living with rare diseases.
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