BUFFALO, NY -- (MARKET WIRE) -- 02/19/08 -- Cleveland BioLabs, Inc. (
Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs, stated, "We are very excited by these results, as Protectan CBLB502's ability to effectively reduce the toxicity of cisplatinum encourages further study of its potential use as an agent to reduce adverse effects of other chemotherapeutic drugs. We have long hypothesized about this application based on CBLB502's superior ability to both protect against and mitigate the damaging effects of radiation, and this new study supports our convictions. The prospect of increasing patients' tolerance to chemotherapeutic drugs and optimizing treatment regiments would be a significant paradigm shift in cancer treatment. It is estimated that approximately 40% of the roughly $50 billion annually spent on cancer treatment represents supportive care addressing side effects of various treatments, including chemotherapy."
Cleveland BioLabs plans to initiate a Phase I/II study in the first half of 2008 for CBLB502 in head and neck cancer patients for reduction of side effects of radiation and chemotherapy, such as mucositis, which can be a treatment-limiting factor. Cisplatinum is commonly used in the treatment of head and neck cancer patients.
Cisplatinum treatment was used in the study as an example of chemotherapy-associated toxicity. Cisplatinum injected at toxic doses is known to induce myelosuppression (suppression of bone marrow) and nephrotoxicity (kidney damage). The severity of these injuries in mice can be monitored by the degree of weight loss and, in the case of severe adverse effects, the proportion of fatalities in treated groups.
In the study, CBLB502 was injected 30 minutes before cisplatinum at a dose of 1 mcg/mouse (0.04 mg/kg, which is less than 1% of maximal tolerable dose). Cisplatinum was injected either at maximal tolerable dose or at double maximal tolerable dose. Mice were monitored daily for weight and behavioral abnormalities for 30 days, or until death. Mice losing more than 25% of their weight were sacrificed, per conventional ethical guidelines for animal treatment.
In mice that received the maximal tolerable dose of cisplatinum, CBLB502-pretreated animals showed neither weight loss nor behavioral signs of morbidity, both of which were seen in all of the control group mice.
In mice that received twice the maximal tolerable dose of cisplatinum, the majority of mice in the control group died or were sacrificed due to loss of more than 25% of weight by day 10; while 100% of the animals that received CBLB502 before cisplatinum survived, never reaching more than 20% weight loss.
Thus in both of these dose groups, a single injection of CBLB502 prior to treatment with cisplatinum strongly reduced the toxicity of the drug, as indicated by less severe weight loss and lack of behavioral changes in treated mice.
Protectan CBLB502 is a derivative of a microbial protein that reduces injury from acute stresses by mobilizing several natural cell protecting mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration promoting cytokines. Potential applications for CBLB502 include reduction of radiation therapy or chemotherapy side effects in cancer patients, and protection from acute radiation syndrome in defense scenarios.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Radiobiology Research Institute. 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 within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Some of the factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's periodic filings with the Securities and Exchange Commission.
Contacts:
Rachel Levine
Director Corporate Development & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com