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
LOS ANGELES, CA (PRWEB) October 6, 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 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.
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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Source : http://www.prweb.com/releases/2004/10/prweb165013.htm