Cleveland BioLabs, Inc. announced that it has received a Notice of Allowance from the US Patent and Trademark Office for its Protectan CBLB502 US Patent Application Number 11/722,682, titled “Flagellin Related Polypeptides and Uses Thereof.” Allowed claims cover composition of matter and use of CBLB502 for protecting a mammal from radiation.
The US Patent and Trademark Office also issued a Notice of Allowance for the company’s Protectan CBLB612 patent application number 11/917,494, titled “Methods of Protecting against Apoptosis using Lipopeptides.” Allowed claims cover the various properties of Protectan CBLB612 and related compounds, including composition of matter and methods of use for protecting against apoptosis.
Yakov Kogan, PhD, MBA, chief operating officer of Cleveland BioLabs, stated, “We are pleased to see the patent portfolio protecting our compounds and technology continue to expand in the US and around the world. These patents validate our unique approach to protection of healthy tissues from the impact of radiation and other acute stresses.”
The company also announced receipt of a Notice of Allowance from the New Zealand patent authority for a patent covering the various properties of Protectan CBLB612 and related compounds, including composition of matter and methods of use for protecting against apoptosis, as well as issuance of a patent for Protectan CBLB612 from the patent authority of South Africa, titled “Method for Increasing and Mobilizing Stem Cells.”
CBLB502 is a rationally–designed, bio-engineered derivative of a microbial protein that potentially reduces injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.
CBLB502 is being developed by Cleveland BioLabs under the FDA’s Animal Efficacy Rule to reduce the risk of or prevent death following total body irradiation during or after radiation disaster. This approval pathway requires demonstration of efficacy in representative animal models and safety, pharmacokinetic, pharmacodynamic and biomarker testing in healthy human subjects.
Evidence of CBLB502's mechanism of action and activity in animal models was published in Science Magazine in April 2008 (Science, 2008, vol. 320, pp. 226-230). Data from 150 healthy human subjects in two phase I safety and tolerability studies indicated that administration of CBLB502 resulted in a rapid and potent cytokine and hepatic immunologic response, similar to that seen in previously conducted non-human primate studies. The most frequent adverse event associated with CBLB502 administration was a transient flu-like syndrome, which generally resolved within 24 hours.
CBLB502 was granted Fast Track and Orphan Drug designations from the FDA for reducing the risk of or preventing death following total body irradiation during or after radiation disaster. The FDA Fast Track programme is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Such programmes include expanded communications (both verbal and written), rolling BLA submission and reviews, priority review (6 month action date instead of 10 month action date) and accelerated drug approval (approval on the basis of a surrogate endpoint). The FDA orphan drug programme provides incentives for sponsors to develop products for rare diseases. Such incentives include extended marketing exclusivity, waiver of BLA filing user fees, grant funding to defray the cost of clinical testing, tax credits for the costs of clinical research and assistance in clinical research study designs.
CBLB612 is a proprietary synthetic agent which has demonstrated the ability to stimulate hematopoietic stem cells and mobilize them into peripheral blood in mouse and primate studies in amounts exceeding documented results of currently marketed drugs. Potential applications for Protectan CBLB612 include accelerated hematopoietic recovery during chemotherapy, as well as during donor preparation for bone marrow transplantation.
Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries around programmed cell death to develop treatments for cancer and protection of normal tissues from exposure to radiation and other stresses.