BIOWATCH

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CYTR back on the move, big news here


CytRx's Tamibarotene Demonstrates Statistically Significant Anti-Tumor Activity
in Animal Trial for Multiple Myeloma

Jun. 17, 2009
Business Editors/Medical Editors

LOS ANGELES--(BUSINESS WIRE)--Jun. 17, 2009--CytRx Corporation (NASDAQ:CYTR), a
biopharmaceutical research and development company engaged in the development
of high-value human therapeutics, today announced that tamibarotene, currently
under evaluation in a U.S. registration trial as a third-line treatment for
acute promyelocytic leukemia (APL), showed statistically significant anti-tumor
activity in human myeloma cells transplanted into animals. Multiple myeloma is
an incurable malignant tumor of the plasma cells of bone marrow. Results of the
trial were published in the June 2009 peer-reviewed journal Cancer Science
(Volume 100, No. 6, Pages 1137-1143).

"These results support our contention that tamibarotene's mechanism of
action may provide broad commercial potential as a therapeutic treatment beyond
APL to other cancers such as multiple myeloma," said Steven A. Kriegsman, CytRx
President and CEO. "Despite advances in therapies that improve the quality of
life and length of survival, many multiple myeloma patients experience severe
side effects from current therapies, prompting the need for additional
therapies."

"We are evaluating opportunities for a Phase 2 clinical program with
tamibarotene as a multiple myeloma therapy, as well as investigating
partnership prospects for developing and commercializing tamibarotene in the
U.S. for both multiple myeloma and APL," he added.

CytRx has the right to develop tamibarotene as a treatment for multiple
myeloma in Europe, and has the option to expand its license for the use of
tamibarotene for multiple myeloma and certain other oncology applications in
the U.S. Tamibarotene is currently approved for relapsed or refractory
treatment of APL in Japan.

The animal trial, conducted by an independent third party in Japan, was
designed to evaluate the activity of tamibarotene as a multiple myeloma
treatment alone and in combination with a glucocorticoid, a commonly prescribed
treatment for this disease. Five different human myeloma cell lines were
treated with tamibarotene alone, glucocorticoids alone, or tamibarotene +
glucocorticoids in cell culture. Tamibarotene by itself inhibited the growth of
these tumor cells two- to 10-fold more potently than all-trans retinoic acid
(ATRA), a less specific relative of tamibarotene which has previously been
shown to inhibit the growth of human myeloma cells. Importantly, the
combination of tamibarotene with glucocorticoids was found to show markedly
greater growth inhibition than either drug alone.

Human myeloma cells were then transplanted into mice with compromised immune
systems to study the tumor growth-inhibitory effects of these drugs. Both
tamibarotene and glucocorticoids by themselves reduced the rate of tumor
growth. However, the combination of tamibarotene with glucocorticoids showed a
synergistic interaction that resulted in markedly decreased tumor growth and
increased survival compared with either drug alone. Trial investigators
concluded that tamibarotene in this drug combination approach was among the
most promising potential therapeutic regimens for multiple myeloma, especially
in high-risk patients, and should be further investigated.

"Our drug tamibarotene is more stable and may have fewer adverse events than
ATRA, with both drugs demonstrating the ability to force certain types of
leukemia cells to cease growing uncontrollably and return to performing their
normal functions - a process known as terminal differentiation," said Jack
Barber Ph.D., CytRx's Chief Scientific Officer. "Multiple myeloma cells are
thought to grow uncontrollably due in part to a growth factor called IL-6.
Glucocorticoids are a potent inducer of cell death; however this benefit may be
offset by their known activation of IL-6 activity. Tamibarotene has previously
shown the ability to interfere with the normal functioning of IL-6, which could
be the foundation for the anti-proliferative effects of tamibarotene in
multiple myeloma, particularly in combination with glucocorticoids.

"We are delighted and encouraged by this proof of concept, which could
ultimately increase the potential market for tamibarotene," added Dr. Barber.