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An Israeli-based subsidiary of Modigene, Inc. (Vienna, VA) has received approval for a grant from the Israeli Office of the Chief Scientist (OCS) to support the company?s development of a long-acting version of human growth hormone (hGH), called hGH-CTP.
An Israeli-based subsidiary of Modigene, Inc. (Vienna, VA) has received approval for a grant from the Israeli Office of the Chief Scientist (OCS) to support the company’s development of a long-acting version of human growth hormone (hGH), called hGH-CTP. In preclinical models, a single injection of hGH-CTP has shown the potential to replace seven to 10 daily injections of commercial hGH. Clinical trials of hGH-CTP are expected to begin in 2008.
Modigene’s technology extends the half-life of therapeutic proteins by attaching a short amino acid sequence, the carboxyl terminal peptide (CTP), which occurs naturally in humans. The potential utility of the technology has been demonstrated by Organon, a unit of Schering-Plough, which licenses the CTP technology for fertility applications. In Phase 2 trials of Organon’s CTP follicle stimulating hormone product (FSH-CTP), a single injection was shown to provide the same clinical effect as seven consecutive daily injections of standard FSH. These trials also demonstrated that attaching the CTP peptide did not affect the therapeutic activity of FSH or cause a negative immune system response.
Modigene has an exclusive license from Washington University (St. Louis, MO) for use of CTP with all therapeutic proteins except four fertility proteins. Modigene currently has two other CTP-enhanced compounds in preclinical testing (interferon beta and erythropoietin) and a fourth-a treatment for Type 2 diabetes-in earlier stage development.
The OCS grant will support Modigene’s hGH-CTP program, based on an estimated development budget of $10 million for 2007–2009. The grant will provide cash reimbursements of 30 to 50% of expenses paid for hGH-CTP product development during this period, including materials, GMP production, salaries, and clinical trials.