Hy BioPharma Inc., is a US and Israeli early stage biopharmaceutical company that is developing and commercializing an innovative drug technology focused on the treatment of cancer, autoimmune disorders, and inflammation. The company announces that it is entering Phase III clinical development, with its lead product hypericin for topical phototherapy of CTCL.
The company has successfully completed its End of Phase II meeting with the FDA and is moving into Phase III development for topical phototherapy of the blood cell skin lymphoma, cutaneous T-cell lymphoma (CTCL) which forms cancer lesions in the skin. The FDA has accorded hypericin orphan drug status for the CTCL indication, thereby providing Hy BioPharma the opportunity to rapidly complete Phase III requirements for filing a new drug application (NDA) to gain marketing approval.
"We are very pleased with the outcome of the End of Phase II meeting with the FDA, and the Company is currently working with the Oncology Division of the FDA to finalize the Phase III Clinical Protocol," said Dr. Alfonso Tobia, President of Hy BioPharma.
The Phase II trial was conducted in the US at several medical centers including the University Of Pennsylvania School Of Medicine in Philadelphia, MD Anderson Cancer Clinic in Houston, and Case Western Medical Center in Cleveland. Hypericin is applied topically as an ointment and photo-activated with natural light twice weekly for 6 weeks. "We expect to initiate the Phase III trial later this year and we anticipate approximately 2 years until its completion, "said Dr. Tobia.
Cutaneous T-cell lymphoma is a slow growing malignancy of T-lymphocytes. It initially manifests in the skin, but eventually spreads to the lymph nodes and internal organs. CTCL is the most common type of primary cutaneous lymphoma, which represents 65% of cases. While the causes of CTCL are still unknown, the incidence of CTCL has more than doubled in the last 20 years with 1,500 new cases diagnosed in the United States every year. Estimates are that approximately 50,000 Americans have CTCL and prognosis is variable based upon the degree of skin involvement at disease onset.
Hy BioPharma's hypericin is also being developed as an oral brain cancer product for the treatment of malignant brain gliomas. Hypericin represents a novel form of anti-cancer therapy. The drug targets Heat-Shock Protein 90 (HSP 90), which controls multiple cell signaling pathways, thereby controlling cell replication and preventing development of tumor metastases.
About Hy BioPharma
Hy BioPharma is a US and Israeli biopharmaceutical company founded in 2006 that is developing and commercializing an innovative drug technology focused on the treatment of cancer, autoimmune disorders, and inflammation. The company has acquired the exclusive worldwide license to the hypericin platform technology intellectual property, and marketing rights from New York University and Yeda R&D Ltd. the Technology Transfer arm of the Weizmann Institute of Science in Rehovot, Israel.
Hypericin is being developed for three clinical indications; CTCL and Psoriasis as a topical phototherapeutic, and Brain Glioblastoma as an oral product. The firm is managed by senior healthcare executives with specialties in Clinical and Preclinical Research, FDA Regulatory and Drug Development, and Global Management of Pharmaceuticals.
The company has corporate offices and clinical development operations located in Jamison, Pennsylvania, USA and research laboratories in Rehovot, Israel.
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