SANTA ANA, Calif., June 15, 2001 (PRIMEZONE) -- Donner Corp. International, a broker/dealer headquartered in Santa Ana, CA., today issued a Morning Call Note on CytRx Corp., Norcross, Georgia (Nasdaq:CYTR). CytRx is a biotechnology company with a DNA delivery technology currently being used by Merck & Co. in Merck's HIV vaccine R&D program and a phase III product, FLOCOR(tm), under development for the treatment of sickle cell disease patients suffering from vaso-occlusive crisis.
The Morning Call Note is as follows:
The U.S. FDA granted CytRx Fast Track Status to its FLOCOR product for the acute chest syndrome (ACS) indication in sickle cell disease (SCD) patients. This means that when CytRx submits an NDA (New Drug Application) to the FDA after completion of successful phase III clinical trials, the FDA's review period would be shortened to 6 months compared to the typical 12 month-time frame. This designation is usually given to a product that targets an unmet medical indication for which there are no current and effective treatments.
FLOCOR is an intra-vascular pharmacological agent that allows red blood cells to easily slide over each other in small blood vessels. In preclinical studies, transgenic mice with SCD and suffering from ACS were treated with FLOCOR. FLOCOR suppressed the development of SCD and significantly reduced mortality. Survival in mice treated with FLOCOR was 80% compared to less than 20% in mice treated with placebo. In a phase I study, preliminary data suggested that FLOCOR was well tolerated with potential benefits. (Final data not yet published). Data from an earlier phase III study in 255 SCD patients with vascular occlusive crisis (another related indication) at 52 medical centers yielded less-than-positive results, as the primary endpoint of the study -- decrease in the length of crisis -- did not reach statistical significance. (That particular study was conducted during 1999 and presented in December 1999). In that study, less than 40% of SCD patients treated with placebo resolved their crisis within a week, the primary endpoint, compared to 52% of SCD patients treated via a 48-hour intravenous injection of FLOCOR. However, in the subset of patients under 15 years of age and in the subset of patients also treated with hydroxyurea, (a current treatment that decreases the frequency of the crises), FLOCOR did statistically and clinically significantly shorten the vascular occlusive crises (VOC). While another phase III study in SCD patients with VOC is in the planning stages, we feel that if or when FLOCOR for ACS enters expanded clinical trials, it would most likely start at phase II due to the existence of data from the VOC trials, in our opinion.
SCD affects 72,000 people in the U.S., mostly in the African-American population. Normal red blood cells are round and deformable while sickle cell red blood cells are rigid and shaped like the "Nike" emblem. Sickle cell red blood cells can clog small blood vessels because those cells cannot slide over each other in capillaries. ACS associated with SCD is characterized by difficulty in breathing, chest pain, and coughing caused by the trapping of red blood cells in the capillaries of the lungs. The annual cost in the U.S. in healthcare expenditures related to SCD is over $1 billion. An SCD patient typically experiences 2 crisis episodes per year.
We still maintain our Speculative Buy rating on CytRx.
Donner Corp. initiated coverage on CytRx Corp. on April 10, 2001 with a Speculative Buy rating. Copies of the April 10, 2001 report on CytRx Corp. are available from Donner Corp. at www.donnercorp.com.
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