Modigene Prepares To Advance Its Long-Acting Human Growth Hormone Toward Clinical Trials Via GMP Manufacturing Agreement
Contract Manufacturer Xcellerex will Produce GMP hGH-CTP for Phase l Trials Projected to Begin Next Year
Vienna, VA - Modigene Inc., today announced that it has signed a contract with Xcellerex, Inc., to provide GMP production of hGH-CTP, Modigene's long-acting human growth hormone (hGH), for upcoming preclinical studies and for the Phase I clinical trials projected to begin next year.
"We are pleased to be working with Xcellerex, a high quality contract bio- manufacturer, as we prepare for clinical trials of our lead hGH-CTP product that are targeted for next year," said Shai Novik, President of Modigene. "Human growth hormone was one of the earliest biotech drugs and remains among the most important for children, but it can require frequent injections. In preclinical studies, our long-acting hGH-CTP has demonstrated its potential to significantly decrease the frequency of these injections, which could provide important benefits for patients. We look forward to having the GMP material on hand to advance hGH-CTP toward clinical trials."
Human growth hormone is a natural protein produced by the pituitary gland in the brain. hGH fuels growth of the body's bone and muscle and has a variety of therapeutic uses. In patients with an hGH deficiency, current treatments involve subcutaneous hGH injections on a near-daily basis. Approximately 95% of children diagnosed with a growth hormone deficiency currently receive treatment, with costs ranging from $10,000 to $30,000 per year. In preclinical models, a single injection of hGH-CTP has shown the potential to replace 7 to 10 daily injections of commercial hGH.
Modigene's technology is based on a short amino acid sequence, the Carboxyl Terminal Peptide (CTP). CTP occurs naturally in humans, and when attached to a therapeutic protein, extends the time that the protein is active in the body. The potential utility of the technology has been demonstrated by Organon, a unit of Akzo Nobel NV, which licenses the CTP technology for fertility applications only. Phase II trials of its CTP follicle stimulating hormone product (FSH-CTP) demonstrated that a single injection provides 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 for use of CTP with all therapeutic proteins except fertility hormones. Modigene currently has four CTP-enhanced compounds in preclinical development and is preparing to initiate clinical trials in 2008.
Under the terms of the agreement, Xcellerex will produce enough hGH-CTP for further preclinical studies as well as for Phase I and Phase II clinical trials.
SOURCE: Modigene Inc.