CytRx Corporation Announces Clinical And Corporate 2006 Milestones

LOS ANGELES, Jan. 11 /PRNewswire-FirstCall/ -- CytRx Corporation today announced projected major 2006 clinical and corporate milestones and reviewed 2005 achievements aimed to advance the Company's goal to develop and commercialize human therapeutics, primarily in the area of small molecules and ribonucleic acid interference (RNAi).

CytRx's 2005 highlights include: * 1Q05 -- Completed enrollment in HIV DNA + protein vaccine Phase I clinical trial * 2Q05 -- Received orphan drug status designation from the U.S. Food and Drug Administration (FDA) for arimoclomol in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) Filed an investigational new drug (IND) application with the FDA for a Phase II clinical trial with arimoclomol for ALS treatment * 3Q05 -- Announced interim positive data from HIV DNA + protein vaccine Phase I clinical trial, indicating the first vaccine to produce potent antibody responses with neutralizing activity against multiple HIV viral strains Commenced a Phase IIa clinical trial with arimoclomol for ALS Granted "Fast Track" designation for arimoclomol for ALS * 4Q05 -- Entered into a significant licensing agreement with the University of Massachusetts Medical School to develop newly discovered obesity and type 2 diabetes drug targets Major CytRx 2006 objectives: * 1Q06 -- Complete enrollment in Phase IIa clinical trial with arimoclomol for ALS * 2Q06 -- Announce final results from a Phase I HIV DNA + protein vaccine clinical trial * 3Q06 -- Report data from Phase IIa clinical trial with arimclomol for ALS Commence pivotal Phase IIb clinical trial following FDA review and acceptance

CytRx also announced that it will continue to expand its program of small molecule drug candidates against targets identified and validated using its proprietary RNAi screening technology at its laboratory in Worcester, Massachusetts. In addition, CytRx hopes to move a lead candidate from its RNAi therapeutics drug development program, which focuses on type 2 diabetes, obesity, cytomegalovirus and ALS, through the development phase toward an IND submission.

"CytRx is in the enviable position of having numerous drug development and discovery programs against novel drug targets in large market disease indications, many of which have no effective treatments," stated CytRx President and CEO Steven A. Kriegsman. "Our plans for 2006 include actively seeking large corporate partners to assist in the development of and advancement toward commercialization of select drug candidates.

"We believe that creating awareness of the Company with the scientific and investment communities is essential to advance CytRx and build substantial increased value for our shareholders. To that end, we also plan to capitalize on opportunities to present at scientific forums and investment conferences," he added.

About ALS

ALS is a progressive degeneration of the brain and spinal column nerve cells that control the muscles that allow movement. According to the ALS Survival Guide, 50% of ALS patients die within 18 months of diagnosis and 80% die within five years. In the U.S., an estimated 30,000 people are living with ALS and nearly 6,000 new cases are diagnosed annually, according to the ALS Association. There are more than 120,000 people living with ALS worldwide.

About Arimoclomol

The current Phase IIa clinical trial is a multi-center, double-blind, placebo-controlled study of patients with ALS. Eighty ALS patients at 10 centers across the U.S. are included in the clinical trial. Patients will receive 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 primary endpoints of the Phase IIa trial are safety and tolerability. Secondary endpoints include a preliminary evaluation of efficacy using two widely accepted surrogate markers, the revised ALS Functional Rating Scale (ALSFRS-R), which is used to determine a patient's capacity and independence in 13 functional activities, and Vital Capacity (VC), an assessment of lung capacity.

The subsequent pivotal Phase IIb trial will be powered to detect more subtle efficacy responses. Although this second trial is still in the planning stages, it is expected to include 300 ALS patients recruited from 25 clinical sites and will take approximately 18 months to complete.

About HIV

HIV, the virus that leads to acquired immune deficiency syndrome (AIDS), remains a global epidemic. World health officials estimate 40 million people are now infected with HIV. Some 3 million people died of AIDS last year, worldwide, and millions more are expected to die from AIDS this year. With the rate of infection accelerating in many parts of the world, the search for an effective HIV vaccine is one of the highest public health priorities. Development of an HIV vaccine has been challenging because of the virus' extraordinary degree of genetic diversity. HIV mutates rapidly in the environment making it an elusive target for traditional vaccine strategies.

About DP6-001

The HIV DNA + protein vaccine formulation, which is exclusively licensed to CytRx, was created by researchers at the University of Massachusetts Medical School (UMMS) and Advanced BioScience Laboratories (ABL). This program is funded under a $16 million five-year HIV Vaccine Design and Development Team contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The HIV vaccine Phase I clinical trial was initiated in April 2004. The goal of the Phase 1 clinical trial is to assess the ability of the vaccine to safely stimulate both antibody and T-cell immune responses to viral protein antigens in the vaccine, including "envelope," which is also carried by HIV. The envelope antigen is a critical protein on the surface of the AIDS virus that facilitates the infection of humans. The vaccine initially "primes" the subject's immune system with injections of DNA that cause the subject's own cells to produce the HIV envelope proteins, followed by protein "boosts" from an injection that contains the corresponding HIV envelope proteins. The vaccine was tested in three groups of healthy volunteers: Group A received the DNA vaccine under the skin, and Groups B and C received the DNA vaccine in muscle, with Group C receiving a six-fold higher DNA dose compared with Groups A and B. All were subsequently "boosted" with the mixture of envelope protein antigen.

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 500 proprietary analogs with potential as backups and new chemical entities (NCE) for new indications related to the mechanism of chaperone co-induction. 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.

About Advanced BioScience Laboratories

Advanced BioScience Laboratories, Inc. (ABL) located in Kensington Md., is a biomedical research, development and manufacturing company focusing on human retroviral diseases. ABL has been a leader in HIV-1 research for more than two decades and has been involved in the development of methods to both prevent and treat HIV-1 infection.

About the University of Massachusetts Medical School

The University of Massachusetts Medical School, one of the fastest growing academic health centers in the country, has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $174 million in research funding annually, 80% of which comes from federal funding sources. Research funding enables UMMS scientists to explore human disease from the molecular level to large-scale clinical trials. Basic and clinical research leads to new approaches for diagnosis, treatment and prevention of disease. Visit www.umassmed.edu for additional information.

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 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: CEOcast, Inc. Ed Umali (eumali@cytrx.com) Investor Contacts: Director of Corporate Communications Kevin Theiss (ktheiss@ceocast.com) (310) 826-5648, ext. 309 Cormac Glynn (cglynn@ceocast.com) (212) 732-4300

CytRx Corporation

CONTACT: Ed Umali of CytRx Corporation, +1-310-826-5648, ext. 309,eumali@cytrx.com; or Investors, Kevin Theiss, ktheiss@ceocast.com, orCormac Glynn, cglynn@ceocast.com, both of CEOcast, Inc., +1-212-732-4300,for CytRx Corporation

MORE ON THIS TOPIC