- Conference Call Scheduled for Today at 4:15 p.m. ET (1:15 p.m. PT) -
LOS ANGELES, Sept. 22 /PRNewswire-FirstCall/ -- CytRx Corporation
(Nasdaq: CYTR), a biopharmaceutical company engaged in the development and
commercialization of human therapeutics primarily in the area of small
molecules and ribonucleic acid interference (RNAi), today announced that after
receiving notification from the U.S. Food and Drug Administration (FDA)
yesterday, it 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). The Company reports that
patient identification has begun at several clinical trial sites, and that
patient enrollment will begin immediately.
"The start of our Phase II trial is a major event for CytRx and the many
thousands who suffer daily from this deadly disease of the nervous system,"
said Steven A. Kriegsman, President and CEO of CytRx. "We are moving
aggressively in our fight against ALS and we expect to rapidly enroll
sufficient numbers of patients for this trial from our carefully selected
clinical sites. Additionally, we have already received numerous inquiries
about this trial from physicians and ALS patients."
"We plan to complete this portion of the Phase II program in the first
half 2006," added Mr. Kriegsman.
Robert H. Brown, Jr, M.D., Professor of Neurology at Harvard Medical
School, founder and director of the Cecil B. Day Laboratory for Neuromuscular
Research at Massachusetts General Hospital (MGH), noted world authority in
ALS, and co-principal investigator of the clinical trial, said, "Arimoclomol
is one of the most promising new neuroprotective drug candidates that I am
aware of. It is thought to work through a novel mechanism that has produced
very exciting results in several animal models. We are all delighted that we
can now move forward with a trial of arimoclomol in ALS."
Louis Ignarro, Ph.D., Nobel Laureate in Medicine and member of CytRx's
Board of Directors and CytRx's Scientific Advisory Board, said, "If
arimoclomol acts similarly in humans as it did in animals, it may inhibit the
progression of ALS and potentially other neurodegenerative diseases such as
Parkinson's and Huntington's." Dr. Ignarro also serves as the Jerome J.
Bezler Distinguished Professor of Pharmacology in the Department of Molecular
and Medical Pharmacology at the UCLA School of Medicine.
Clinical Development Plan
The current Phase II clinical trial (Phase IIa) is a multicenter,
double-blind, placebo-controlled study of patients with ALS. 80 ALS patients
at eight to ten centers across the U.S. will be 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 this Phase II 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 patient's capacity and independence in
13 functional activities, and Vital Capacity (VC), an assessment of lung
capacity. The trial is powered to monitor only extreme responses in these two
categories.
The subsequent Phase II trial (Phase IIb), which is planned to begin soon
after completion of the present Phase II study subject to FDA approval, 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.
According to Mr. Kriegsman, "Given the devastating health consequences of
ALS, and the lack of an effective therapeutic treatment, we believe that
successfully demonstrating safety and efficacy in this latter Phase II
clinical trial could be sufficient to support product registration with the
FDA."
The Principal Investigators
CytRx has assembled a team of renowned clinicians to conduct the Phase II
clinical trial with Dr. Brown, Merit Cudkowicz, M.D., and Jeremy Shefner, M.D.
acting as co-principal investigators for the study. Dr. Cudkowicz is
Associate Professor of Neurology at Harvard Medical School, co-chair of the
Northeastern ALS Clinical Trials Consortium, co-director of the MGH Clinical
Trials unit, and is an experienced principal investigator of ALS clinical
trials. Dr. Shefner is Professor of Neurology at SUNY Upstate Medical
University, co-chair of the Northeastern ALS Clinical Trials Consortium, and
is also an experienced principal investigator of ALS trials.
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.
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. Receipt of
orphan designation holds numerous potential benefits, including opportunities
for grant funding toward clinical trial costs, tax advantages, FDA use-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.
About ALS
ALS is a progressive degeneration of the brain and spinal column nerve
cells that control the muscles that allow movement. Over a period of months
or years, ALS causes increasing muscle weakness, inability to control movement
and problems with speaking, swallowing and breathing. 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.
Conference Call
CytRx has scheduled a conference call regarding this announcement to be
held today, September 22, 2005, beginning at 4:15 p.m. Eastern Time.
Individuals interested in listening to the conference call may do so by
dialing (888) 463-4383 toll free within the U.S. and Canada, or (706) 679-5355
for international callers. A telephone replay of the conference call will be
available for 48 hours beginning September 22nd within two hours after the
conclusion of the call, by dialing (800) 642-1687 domestically, or
(706) 645-9291 internationally and entering reservation number 9844670.
The live conference call will also be available to interested parties via
the Internet at http://www.cytrx.com. A replay of the call will be available on the
Company's web site for 90 days following the completion of the call.
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. CytRx has previously announced that a
novel HIV DNA + protein vaccine exclusively licensed to CytRx and developed by
researchers at 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. CytRx also has a broad-based
strategic alliance with UMMS to develop novel compounds in the areas of ALS,
obesity, type 2 diabetes and cytomegalovirus (CMV) using RNAi technology. 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.
SOURCE CytRx Corporation
 back to top
Related links:
http://www.cytrx.com
CONTACT:
Ed Umali, Director of Corporate
Communications of CytRx Corporation, +1-310-826-5648 ext 309,
eumali@cytrx.com; or Investors, Jody Cain, jcain@lhai.com, or
Mariann Ohanesian, mohanesian@lhai.com, or Media, Mark Stuart,
mstuart@lhai.com, all of Lippert/Heilshorn & Associates,
+1-310-691-7100, for CytRx Corporation
|
