Archive for the ‘HIV Research’ Category

LOS ANGELES, Jan. 11 /PRNewswire-FirstCall/ — CytRx Corporation
(Nasdaq: CYTR) 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 http://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 http://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