VIENNA, Va., Nov. 27 Modigene Inc.(OTC Bulletin Board: MODG) today reported that its Israeli-based R&Dsubsidiary has received approval for a special grant from the Israeli Officeof the Chief Scientist ("OCS") in support of the company's development programfor hGH-CTP, its longer-acting version of human growth hormone (hGH). Inpreclinical models, a single injection of hGH-CTP has shown the potential toreplace 7 to 10 daily injections of commercial hGH.
The OCS has approved a special grant to support Modigene's hGH-CTPprogram, based on an estimated development budget of $10 million for calendaryears 2007-2009. The grant will provide cash reimbursements of 30% to 50% ofexpenses paid for hGH-CTP product development during this period, includingmaterials, GMP production, salaries and clinical trials. hGH-CTP is currentlyin preclinical development, with clinical trials expected to begin in 2008.
Human growth hormone is a natural protein produced by the pituitary glandin the brain. It fuels growth of the body's bone and muscle and has a varietyof therapeutic uses. Patients with an hGH deficiency currently receivesubcutaneous hGH injections on a near-daily basis. Approximately 95% ofchildren diagnosed with a growth hormone deficiency receive treatment, withcosts ranging from $10,000 to $30,000 per year. The current annual market forhGH therapies exceeds $2 billion.
"This generous new grant from the OCS is an important non-dilutive cashresource for Modigene and represents another validation of the potential ofour lead candidate," said Abraham Havron, Ph.D., Chief Executive Officer ofModigene. "The OCS has already awarded Modigene funds in support of our EPO-CTP product candidate and we are delighted that our hGH-CTP program has nowalso been selected for support. This visionary OCS program is particularlyattractive for Modigene because it does not require any repayment until theproduct is generating revenue. We are grateful for this valuable source ofnon-dilutive capital."
Under the terms of the grant, Modigene shall repay the OCS the sum of thegrant plus accrued interest through a series of payments that begin only uponsuccessful commercialization of the hGH-CTP product, or other productsdeveloped at the company with its CTP technology.
Modigene's technology is based on a short amino acid sequence, theCarboxyl Terminal Peptide (CTP). CTP occurs naturally in humans, and whenattached to a therapeutic protein, extends the time that the protein is activein the body. The potential utility of the technology has been demonstrated byOrganon, a unit of Schering-Plough, which licenses the CTP technology forfertility applications only. Phase II trials of its CTP follicle stimulatinghormone product (FSH-CTP) demonstrated that a single injection provides thesame clinical effect as seven consecutive daily injections of standard FSH.These trials also demonstrated that attaching the CTP peptide did not affectthe therapeutic activity of FSH or cause a negative immune system response.Modigene has an exclusive license from Washington University for use of CTPwith all therapeutic proteins except four fertility proteins. Modigenecurrently has three CTP-enhanced compounds in preclinical testing and a fourthin earlier stage development.
Modigene Inc. (OTCBB: MODG) is a biopharmaceutical company applying itspatented CTP technology to develop longer-acting, proprietary versions ofalready approved therapeutic proteins that currently generate billions ofdollars in annual global sales. The CTP technology is applicable to virtuallyall proteins and Modigene is currently developing long-acting versions ofhuman growth hormone, interferon beta and erythropoietin, which are in latepreclinical development, as well as GLP-1. For more information on Modigene,visit http://www.modigeneinc.com.
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