Cleveland BioLabs, Inc., Completes Analysis Of Data Generated In A Primate Trial Of Protectan CBLB502

Main Category: Radiology / Nuclear Medicine
Also Included In: Clinical Trials / Drug Trials
Article Date: 01 Aug 2006 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Cleveland BioLabs, Inc. (Nasdaq: CBLI) (Boston Stock Exchange: CFB) today announced that it has completed its analysis of non-human primate trials of its lead radioprotective drug candidate Protectan CBLB502. These trials demonstrated that CBLB502 provides an unprecedented increase in survival among lethally irradiated non- human primates compared with the untreated control group. The trials showed effectiveness in protection against Acute Radiation Syndrome (ARS). ARS is a potentially fatal condition resulting from exposure to radiation from a military attack with a nuclear device, terrorist action, or nuclear accident. Generated results demonstrated that CBLB502 was active against both types of ARS, specifically, hematopoietic and gastro-intestinal syndromes in the primates which suggests that the Company's radioprotectant is activating a broad variety of biological processes contributing to the observed increase in the radio-resistance of mammals.

In these trials, 75% of Rhesus monkeys irradiated with a single 6.5 Gy bilateral whole-body dose of gamma irradiation treated with a single dose of CBLB502 survived the lethal irradiation (compared to only a 25% survival rate in the untreated control group). Half of the surviving primates which received an injection of CBLB502 showed no detectable gross pathological changes 40 days after treatment, and the histology of their lymphoid organs and bone marrow appeared normal. Whereas, all surviving primates from the untreated control group suffered multiple severe abnormalities and injuries. The observed radioprotective efficacy of CBLB502 may be attributed to a rapid and substantial increase in the blood concentration of a number of tissue protecting growth factors and cytokines following its injection.

"We believe that these remarkable results demonstrate the potential of CBLB502 as a powerful radioprotector and represent a significant step towards FDA approval of our radiation antidote candidate for military and civil defense applications," said Michael Fonstein, CEO and President of CBL. He added: "We are equally excited by the lack of gross pathological changes seen in half of the CBLB502-treated animals."

About Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc. is a drug discovery and development company with the goal to identify and develop new types of drugs for the protection of normal tissues from exposure to radiation and other stresses, such as toxic chemicals and for cancer treatment. Our development efforts are based on discoveries made in connection with the investigation of the cell-level process known as apoptosis. To learn more about Cleveland BioLabs Inc., please visit the company's website at http://www.cbiolabs.com.

This press release contains forward-looking statements that reflect our current view with respect to various aspects of the events described above, including, without limitation, the potential effects and mechanisms of action of the Company's drug compounds. Actual results could be significantly different. Factors that could affect results include those set forth in filings made by Cleveland BioLabs, Inc. with the Securities and Exchange Commission. These factors include, but are not limited to, those discussed in our Registration Statement on Form SB-2 under the caption "Risk Factors." We caution readers not to place undue reliance on these forward-looking statements. Although forward-looking statements help provide complete information about future prospects, readers should keep in mind that forward- looking statements are much less reliable than historical information.

Cleveland BioLabs, Inc.
http://www.cbiolabs.com