CytRx Corporation (NASDAQ: CYTR), located in Los Angeles, California, is a biopharmaceutical research and development company engaged in developing human therapeutic products based primarily upon our small-molecule molecular “chaperone” amplification technology.
CytRx completed a three-month Phase IIa clinical trial and six-month open-label trial extension for that trial for its lead small-molecule product candidate, arimoclomol, for the treatment of amyotrophic lateral sclerosis, which is commonly known as ALS, or Lou Gehrig’s disease. Arimoclomol for the treatment of ALS has received Orphan Drug and Fast Track designation from the U.S. Food and Drug Administration, or FDA, and orphan medicinal product status from the European Medicines Agency.
CytRx initiated a Phase IIb efficacy trial of arimoclomol for this indication in December 2007. Based on preliminary discussions with the FDA, CytRx plans to conduct a second efficacy clinical trial of arimoclomol for ALS, possibly in parallel with the upcoming Phase IIb trial, to provide additional efficacy data to support a possible approval decision by the FDA.
Subject to FDA clearance, CytRx plans to commence in the first half of 2008 a Phase II clinical trial for arimoclomol in stroke recovery and a Phase II clinical trial of our next drug candidate, iroxanadine, for diabetic ulcers.
CytRx recently opened a research and development facility in San Diego, California, to provide the company with a dedicated laboratory to accelerate its molecular chaperone drug development programs.
Prior to 2007, CytRx was engaged directly in developing therapeutic products based upon ribonucleic acid interference, or RNAi, which has the potential to effectively treat a broad array of diseases by interfering with (sometimes referred to as silencing) the expression of targeted disease-associated genes. In order to fully realize the potential value of our RNAi technologies, in January 2007 CytRx transferred to RXi Pharmaceuticals Corporation, its majority-owned subsidiary, substantially all of the company's RNAi-related technologies and assets in exchange for common stock of RXi.
RXi is dedicated to developing and commercializing therapeutic products based upon RNAi technologies for the treatment of human diseases, with an initial focus on neurodegenerative diseases, cancer, type 2 diabetes and obesity.
In furtherance of our strategy for RXi, CytRx announced in early 2007 a plan to distribute to its stockholders shares of RXi common stock constituting approximately 36% of the outstanding RXi shares. On October 30, 2007, RXi filed with the Securities and Exchange Commission a registration statement on Form S-1 to register the shares of RXi common stock that will be distributed to CytRx stockholders.