LOS ANGELES, July 21 PRNewswire-FirstCall
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Published: 2005/07/21 09:00:15 CDT
Rednova 2004
CytRx Corporation today announced that it has been in communication with the U.S. Food and Drug Administration (FDA) regarding the filing of CytRx's Investigational New Drug (IND) application. The filing, announced on May 23, 2005, is for a planned Phase II clinical trial of CytRx's small molecule drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The FDA has verbally informed the Company that the trial has been placed on clinical hold pending review of additional information that CytRx will be asked to provide. In the interim, CytRx expects to be in active dialogue with the FDA to address any outstanding matters.
"We appreciate the FDA's consideration in carefully reviewing our IND and intend to work diligently with them to address any questions that they may have so that this important study can proceed," said Steven A. Kriegsman, President and CEO of CytRx. "We are committed to advancing our clinical studies in Lou Gehrig's disease, for which there currently is no effective therapeutic treatment."
The Phase II trial is designed to investigate the safety and tolerability of arimoclomol in ALS patients. Arimoclomol, which was well absorbed and well tolerated in two Phase I clinical trials in healthy volunteers, was granted orphan drug status designation by the FDA for the treatment of ALS in May 2005. ALS is a progressive degeneration of the brain and spinal column nerve cells that control the muscles that allow movement.
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.
CytRx Corporation
CONTACT: Ed Umali, Director of Corporate Communications, CytRxCorporation, +1-310-826-5648, ext. 309, eumali@cytrx.com ; or Investors, JodyCain, jcain@lhai.com, or Mariann Ohanesian, mohanesian@lhai.com , or Media,Mark Stuart, +1-310-691-7100, mstuart@lhai.com , all of Lippert/Heilshorn &Associates, for CytRx Corporation
Web site: http://www.cytrx.com
Story from REDNOVA NEWS:
http://www.rednova.com/news/display/?id=181984
Published: 2005/07/21 09:00:15 CDT
Rednova 2004