EXHIBIT 99.1
FOR ADDITIONAL INFORMATION:
CytRx Corporation:
Ed Umali
Director of Communications
310/826-5648
eumali@cytrx.com
Investor Relations Group:
Jane Lin/John Nesbett
212/825-3210
CYTRX CORPORATION ADDS THREE ORAL CLINICAL STAGE DRUG CANDIDATES WITH
ACQUISITION OF ASSETS OF BIOREX RESEARCH & DEVELOPMENT COMPANY AND CLOSES
RELATED FINANCING
ACQUISITION EXPANDS AND ACCELERATES CYTRX'S DRUG DEVELOPMENT PIPELINE WITH
PLANNED ENTRY INTO PHASE II CLINICAL TRIALS FOR ALS/LOU GEHRIG'S DISEASE BY
SECOND QUARTER 2005
CYTRX TO HOLD A CONFERENCE CALL ON OCTOBER 5, 2004 AT 11:00 AM EST TO DISCUSS
DETAILS OF ACQUISITION
LOS ANGELES, CA - OCTOBER 5, 2004 - CytRx Corporation (NASDAQ: CYTR) has
acquired all the clinical and pharmaceutical assets and related intellectual
property of Hungary-based Biorex Research & Development RT. ("Biorex"), a
privately held biotechnology company focused on the development of novel small
molecules with broad therapeutic applications in neurology, diabetes, and
cardiology. This acquisition dramatically accelerates CytRx's entry into
clinical testing for amyotrophic lateral sclerosis (ALS; Lou Gehrig's Disease),
with an anticipated initiation of a Phase II clinical trial for the drug
arimoclomol during the second quarter of 2005. The acquisition of Biorex's
assets also provides CytRx with a pipeline of at least two additional oral drug
candidates at various stages of clinical development up to Phase II, a library
of 500 small molecule drug candidates and an extensive intellectual property
portfolio. In connection with the acquisition, CytRx paid a cash purchase price
of US $3,000,000 and agreed to make milestone payments upon the occurrence of
certain regulatory filings and approvals related to the acquired products.
Steven A. Kriegsman, CytRx's President and CEO, discussed the company's
rationale for the transaction, "In the past several months, CytRx has refined
its business strategy to focus on
the development of therapeutics for ALS, obesity/type 2 diabetes, HIV and CMV.
This acquisition significantly expands and accelerates our efforts in ALS by
providing us with arimoclomol, a clinical-stage ALS drug with substantial
revenue potential. We believe we can reach clinical proof-of-principle quickly
with arimoclomol, since the drug has already demonstrated therapeutic efficacy
in a pre-clinical model of ALS and was well absorbed and well tolerated in Phase
I clinical trials. Due to the severity of ALS and the current lack of an
effective treatment, we expect that arimoclomol will receive orphan drug status
with the FDA. Therefore, a Phase II trial demonstrating efficacy could be
sufficient to support registration for marketing. Additionally, the opportunity
to obtain three small molecules in one transaction, each of which has
substantial human safety data and therapeutic potential, further strengthens our
product pipeline to complement our ongoing work in the development of RNAi
therapeutics."
Dr. Robert H. Brown, Jr., Professor of Neurology at Harvard Medical School,
founder of the Cecil B. Day Laboratory for Neuromuscular Research at
Massachusetts General Hospital, and a recognized authority on ALS and member of
CytRx's Scientific Advisory Board said, "The preliminary data makes arimoclomol
an extremely important ALS drug candidate because of its demonstrated safety
profile and the potential to treat both sporadic (spontaneous) and familial
(inherited) forms of ALS."
PORTFOLIO OF THREE ACQUIRED DRUG CANDIDATES:
Biorex's small molecule drugs provide cellular protection from abnormal proteins
by activating molecular "chaperone" proteins that can repair or degrade the
damaged proteins that are believed to cause many diseases, including ALS.
ARIMOCLOMOL (ALS, LOU GEHRIG'S DISEASE)
Originally developed to treat diabetic complications, arimoclomol was recently
discovered to significantly inhibit progression of ALS in an experimental animal
model of the disease (Kierin et al., Nature Medicine, April 2004, Vol. 10(4),
402-5).
"The mechanism of these drugs accomplishes the same goal as RNAi, removal of
toxic proteins, but does it at the protein level instead of at the RNA level,"
said Jack Barber, Ph.D., CytRx Senior Vice President of Drug Development.
The company's RNAi approach seeks to prevent the production of a toxic protein
that causes disease in a subset of ALS patients that have inherited a mutation
in the superoxide dismutase 1 (SOD1) gene. CytRx believes that arimoclomol would
not only target the SOD1 protein, but also additional toxic proteins that may be
involved in the more common ("sporadic") form of ALS as well. Arimoclomol would
thus dramatically increase the number of treatable ALS patients, compared with
the RNAi approach. "We plan to continue development of our RNAi approach to ALS
concurrently with developing arimoclomol, but if both drugs prove to be
effective, we would focus any immediate clinical development activities on the
orally available arimoclomol, since it addresses a broader patient population,"
said Dr. Barber.
IROXANADINE (DIABETES AND CARDIOVASCULAR DISEASE)
Iroxanadine has been tested in two Phase I clinical trials and one Phase II
clinical trial where it was well tolerated and showed signs of efficacy,
significantly improving the function of endothelial cells in blood vessels of
patients at risk of cardiovascular disease. CytRx intends to initially develop
the drug to improve endothelial dysfunction in indications with what it believes
will be clinical end-points that can be demonstrated relatively quickly, such as
diabetic wound healing. The company hopes to demonstrate efficacy in these
smaller market indications to build value as part of a strategy to potentially
out-license iroxanadine to one or more larger pharmaceutical companies for the
major market cardiovascular indications.
Dr. Louis Ignarro, Noble Laureate, CytRx's Chief Scientific Spokesman and world
authority in cardiovascular disease noted, "The safety and efficacy data from
two Phase I clinical trials and one Phase II trial are extraordinary and provide
CytRx with a clear roadmap to quickly bring iroxanadine to market to address
endothelial dysfunction, a common complication associated with diabetes."
BIMOCLOMOL
Bimoclomol is a drug that has been shown to be safe in two large Phase II
clinical trials. Although the drug did not show efficacy for diabetic
neuropathy, the indication for which it was tested, CytRx believes this compound
could be effective for other therapeutic indications.
DETAILS OF THE TRANSACTION AND FINANCING
In conjunction with this acquisition, CytRx completed a private placement of
4,000,000 shares of its common stock to institutional investors, with gross
proceeds of $4 million. The company also issued warrants to purchase an
additional 2,800,000 shares of common stock exercisable at an exercise price of
$1.72 per share for a period of five years. CytRx has agreed to register all of
the privately placed shares of common stock, together with the shares issuable
upon exercise of the warrants, for resale.
The offering proceeds were used to acquire the assets of Biorex. Rodman &
Renshaw served as the lead placement agent in the financing. Rodman & Renshaw
also served as financial advisor to CytRx Corporation on the acquisition.
CONFERENCE CALL DETAILS
CytRx has scheduled a conference call to discuss the acquisition of Biorex
Research & Development RT. for Tuesday, October 5, 2004 at 11:00 AM EST.
Participants are asked to call the following numbers 5-10 minutes prior to the
starting time:
- - From the U.S. and Canada: 1-888-855-5487
- - International: 719-457-2666
- - Internet: www.cytrx.com or
https://cis.premconf.com/sc/scw.dll/usr?cid=vlllrwdcdcnvrwzws
A replay will be available for 30 days after the call by dialing 1-888-203-1112
(US and Canada) or 719-457-0820 (International) and entering access code 830845
when prompted and is also available through the company's website at
www.cytrx.com or https://cis.premconf.com/sc/scw.dll/usr?cid=vlllrwdcdcnvrwzws.
For more information, call: Jane Lin or Dian Griesel, Ph.D. at The Investor
Relations Group, Inc. Phone: 212-825-3210.
ABOUT CYTRX CORPORATION
CytRx Corporation is a biopharmaceutical research and development company, based
in Los Angeles with a subsidiary in Worcester, Massachusetts. The company is
engaged in the development of products, primarily in the area of ribonucleic
acid interference (RNAi) and small molecules, in a variety of therapeutic
categories. The company has a broad-based strategic alliance with the University
of Massachusetts Medical School to develop novel compounds in the areas of ALS,
obesity, type 2 diabetes and 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 also 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
website at www.cytrx.com.
This press release may contain forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended, that 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 the early stage of
CytRx's diabetes, obesity, CMV and ALS research, the need for future clinical
testing of any RNAi-based products and small molecules that may be developed by
CytRx, uncertainties regarding the scope of the clinical testing that may be
required by regulatory authorities for the products acquired from Biorex and
other products and the outcomes of those tests, 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 the drugs purchased from Biorex, 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.
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