Company Expects to Initiate Clinical Trial in Third or Fourth Quarter of 2005
LOS ANGELES, Aug. 10 /PRNewswire-FirstCall CytRx Corporation (Nasdaq: CYTR) today announced that the U.S. Food and Drug Administration (FDA) has provided a written explanation of the reasons for the clinical hold placed on the Company's Phase II trial for its oral drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). On July 21, 2005, CytRx announced communication from the FDA requesting additional information relating to its planned Phase II clinical trial for ALS with the reasons to be explained in subsequent correspondence. In an e-mail received Friday, August 5, 2005, the FDA cited two actions required to be taken by CytRx in order to lift the clinical hold. The FDA requested the following:
- * Submission by CytRx of existing clinical information on its related small molecule drug candidate bimoclomol, which has been more extensively tested for safety in humans than arimoclomol.
- * Amendment by CytRx of the protocol for the clinical trial to add specific clinical tests to be administered to patients enrolled in the study.
"We are working diligently to satisfy the requirements cited by the FDA in order to proceed with this important study," said Steven A. Kriegsman President and CEO of CytRx. "We plan to submit our official response as quickly as possible and, following FDA review, we anticipate beginning this Phase II trial for ALS before the end of the this year, and possibly within the third quarter."
About CytRx Corporation CytRx Corporation is a biopharmaceutical research and development company engaged in the development of products, primarily in the area of small molecules and ribonucleic acid interference (RNAi), in a variety of therapeutic categories. The Company owns three clinical-stage compounds based on its small molecule molecular "chaperone" co-induction technology, as well as a targeted library of 500 small molecule drug candidates that may be used to screen for new drug candidates. The Company expects to enter a Phase II clinical trial with its lead orally-administered small molecule drug candidate, arimoclomol, for the treatment of ALS (Lou Gehrig's disease). CytRx also has a broad-based strategic alliance with the University of Massachusetts Medical School (UMMS) to develop novel compounds in the areas of ALS, obesity, type 2 diabetes and cytomegalovirus (CMV) using RNAi technology. CytRx also licensed from UMMS the rights to a DNA-based HIV vaccine technology currently in a Phase I clinical trial. The Company has a research program with Massachusetts General Hospital, Harvard University's teaching hospital, to use RNAi technology to develop a drug for the treatment of ALS. For more information, visit CytRx's Web site at http://www.cytrx.com
Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Examples of such statements include, but are not limited to, statements relating to the expected timing, scope and results of our clinical development and research programs, including the initiation of clinical trials, and statements regarding the potential benefits of our drug candidates and potential drug candidates. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties regarding regulatory approvals for clinical testing and the scope of the clinical testing that may be required by regulatory authorities for its molecular chaperone co-induction drug candidates, including arimoclomol, and other products, and the timing and outcomes of those tests, uncertainties related to the early stage of CytRx's diabetes, obesity, cytomegalovirus and ALS research, the need for future clinical testing of any RNAi-based products and small molecules that may be developed by CytRx, the significant time and expense that will be incurred in developing any of the potential commercial applications for CytRx's RNAi technology or small molecules, CytRx's need for additional capital to fund its ongoing working capital needs, including ongoing research and development expenses related to its molecular chaperone co-induction drug candidates, risks relating to the enforceability of any patents covering CytRx's products and to the possible infringement of third party patents by those products, and the impact of third party reimbursement policies on the use of and pricing for CytRx's products. Additional uncertainties and risks are described in CytRx's most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-K. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events or otherwise.