LOS ANGELES, Jan. 23 /PRNewswire-FirstCall/ -- CytRx Corporation , a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that it has submitted a protocol to the FDA reflecting its plans to treat patients in an open-label extension of its ongoing Phase II clinical trial with its orally administered, small molecule product candidate arimoclomol for the treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease).
CytRx expects to provide all patients who complete the ongoing Phase II trial with the opportunity for treatment with arimoclomol at the highest dose level three times daily for an additional six months. In the currently- underway 80-patient, 10-center, double-blind Phase II study, patients are receiving either placebo (a capsule without drug), or one of three dose levels of arimoclomol capsules three times daily for a period of 12 weeks. The open- label extension trial is designed to provide additional safety and tolerability data in combination with the current Phase II trial.
“It is not surprising that patients enrolled in our trial have expressed high interest in an open-label extension option with arimoclomol for the treatment of ALS. Currently, there are no effective therapeutic treatments available for those suffering from this devastating neurodegenerative disease that carries an average life expectancy of 18 months following diagnosis,” said Steven A. Kriegsman, CytRx’s President and CEO. “We are exceptionally pleased to offer this opportunity to patients who completed our trial, and particularly to those who received placebo or arimoclomol at lower dose levels.”
CytRx expects to report final data from its ongoing Phase II trial with arimoclomol for ALS in the third quarter of this year, followed by initiation of a pivotal Phase IIb clinical trial subject to FDA review and acceptance. The Company believes that successfully demonstrating safety and efficacy in this latter Phase II clinical trial could be sufficient to support product registration with the FDA.
In 2005 CytRx announced that arimoclomol was granted orphan drug status and Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of ALS. Benefits of orphan designation include opportunities for grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, seven years of U.S. market exclusivity should the FDA grant marketing approval for the drug and an added mechanism for more frequent communication with the FDA. The benefits of Fast Track include scheduled meetings seeking FDA input into development plans, the option of submitting a new drug application (NDA) in sections rather than submitting all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints.
About Arimoclomol
Arimoclomol is one of CytRx’s three orally administered, small molecule compounds. This small molecule drug candidate is believed to function by stimulating a normal cellular protein repair pathway through the activation of “molecular chaperones.” Since damaged proteins called aggregates are thought to play a role in many diseases, CytRx believes that activation of molecular chaperones could have therapeutic efficacy for a broad range of diseases.
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). 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. CytRx has initiated a Phase II clinical trial with its lead small molecule product candidate arimoclomol for the treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). Arimoclomol has received Orphan Drug and Fast Track designation from the U.S. Food and Drug Administration. CytRx has previously announced that a novel HIV DNA + protein vaccine exclusively licensed to CytRx and developed by researchers at the University of Massachusetts Medical School (UMMS) and Advanced BioScience Laboratories, and funded by the National Institutes of Health, demonstrated very promising interim Phase I clinical trial results that indicate its ability to produce potent antibody responses with neutralizing activity against multiple HIV viral strains. For more information, visit CytRx’s Web site at 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 related to regulatory approvals for clinical testing, including FDA approval of the open-label extension of CytRx’s ongoing Phase II clinical trial for arimoclomol in ALS, 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.
For Additional Information: CytRx Corporation: Ed Umali (eumali@cytrx.com) Director of Corporate Communications (310) 826-5648, ext. 309 CEOcast, Inc. Investor Contacts: Kevin Theiss (ktheiss@ceocast.com) Cormac Glynn (cglynn@ceocast.com) (212) 732-4300
CytRx Corporation
CONTACT: Ed Umali, Director of Corporate Communications of CytRxCorporation, +1-310-826-5648, ext. 309, eumali@cytrx.com; or Investors,Kevin Theiss, ktheiss@ceocast.com, or Cormac Glynn, cglynn@ceocast.com,both of CEOcast, Inc., +1-212-732-4300, for CytRx Corporation
Web site: http://www.cytrx.com//
