US-Israeli start-up Hy Biopharma Inc., which has been almost anonymous in the local market until now, announced that it plans to shortly begin Phase III clinical trials of its cancer drug. The company's product, HBP-347, is based on patents held by the Weizmann Institute of Science and New York University (NYU) and based on hypericin.
Hy Biopharma science advisory board director Dr. Gad Lavie, who invented the company's technology, said that the company had kept a low profile because the product was brought through to the Phase II clinical trial by a US company, Vimerex, which no longer exists.
Lavie said, "The agreement between NYU and Yeda R&D Company Ltd., the technology transfer arm of the Weizmann Institute, stipulated that Vimerex would either return the patents to NYU and the Weizmann Institute, or pay 40% royalties. Under these terms, it could not commercialize the product, which is now happily back with the research institutes."
Hy Laboratories Ltd., repurchased the patents in 2006. Hy Laboratories was owned by Hy Biopharma CEO Michael Sternberg and VP research Dr. Zadik Hazan. They recruited former Viremex executive Dr. Alfonso Tobia to serve as president of the company. Tobia invested $750,000 of his own money in Hy Biopharma out of the $1.3 million invested in the company altogether.
Hy Biopharma's drug is based on hypericin, an active pharmaceutical ingredient (API) found in St. John's Wort. A different API found in St. John's Wort is used to treat depression. The company produces synthetic hypericin, which means that the product is a chemical drug for all intents and purposes, and not a herbal remedy.
The company is using hypericin to treat cutaneous T cell lymphoma, a skin cancer, which the company says affects 1,500 persons a year. The company obtained orphaned drug status from the US Food and Drug Administration (FDA) for the treatment because of the disease's rarity. Orphan drug status will give the company a seven-year exclusivity if the treatment is successful. Tobia says that only 80 patients needed to be recruited for the Phase III trial.
Hy Biopharma plans to shortly begin a Phase III trial for hypericin for the treatment of brain cancer, and two Phase II trials for hypericin for the treatment of autoimmune diseases, inflammatory bowel diseases and psoriasis.
Published by Globes [online], Israel business news - www.globes-online.com - on May 27, 2008
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