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CBLI signs Protectan development pact

Cleveland BioLabs has signed a licensing agreement worth $1.65 million that gives a Chinese pharmaceutical company exclusive rights to develop and sell a version of its Protectan drug that stimulates stem cell growth in cancer patients.

The agreement also requires the Chinese manufacturer, Hisun Pharmaceutical Co. Ltd., to pay Cleveland BioLabs a 10 percent royalty on its net sales of Protectan CBLB612 in China. The agreement only covers sales in China; Cleveland BioLabs retains all marketing rights for the drug in the rest of the world.

Michael Fonstein, Cleveland BioLabs' president and chief executive officer, said the licensing agreement will help the company's own efforts to commercialize the drug by giving the company access to pre-clinical and clinical data generated by Hisun as it attempts to win approval from Chinese regulators for its use.

That data "will provide valuable insights for our own developmental efforts," Fonstein said. Several rounds of clinical studies would need to be completed before the drug could be submitted for approval by U.S. regulators.

Protectan CBLB612 stimulates the development of a type of stem cells. It has been shown in studies to promote the production of stem cells in mice and non-human primates, potentially reversing a common side effect of cancer patients undergoing chemotherapy.

Protectan CBLB612 "may play a significant role in improving treatment options for people with cancer," said Hua Bai, Hisun's president and chief executive officer, in a statement. "We believe a drug with these properties would be extremely valuable to physicians and cancer patients in China."

Cleveland BioLabs, however, has been focusing its limited financial resources on its development efforts for another version of Protectan that could be used to protect people from the harmful effects of radiation exposure.

The agreement with Hisun lasts for 20 years and would decrease the royalty payment to 5 percent of Protectan CBLB612's net sales if patents for the drug are not granted.


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