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"The success of Schering-Plough's Phase III trial of its long-acting FSHfertility hormone marks a major milestone for the CTP platform technology thatis the basis for our new drug pipeline," said Avri Havron, Ph.D., CEO ofModigene. "We believe these positive results provide independent support ofour own plans for clinical trials of Modigene's CTP-enhanced versions of humangrowth hormone and interferon beta that we intend to initiate next year."
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On July 8, 2008 Schering-Plough announced successful top-line data fromits Phase III ENGAGE trial demonstrating that women receiving a singleinjection of FSH-CTP achieved the same pregnancy rates as women receivingseven consecutive daily injections of FSH, a primary endpoint of the study.This 1,509 patient trial was the largest double-blind fertility trial everconducted.
Human growth hormone (hGH), which is used to treat growth failure inchildren and frailty in adults, must currently be injected between three andseven times per week, while interferon beta (IFN-Beta), which is prescribedfor the treatment of multiple sclerosis, must be injected between one andthree times per week. Neither of these therapies has a commercial long-actingversion available, and their current market sizes are estimated at $2.2billion and $4.3 billion, respectively.
Modigene's hGH-CTP and IFN-Beta-CTP are in late preclinical development.Based on studies in relevant animal models, researchers project once-weeklyadministration of hGH-CTP compared to the multiple daily injections requiredfor commercial hGH, and once-every two-to-four weeks administration ofIFN-Beta-CTP, compared to the one-to-three times per week injections currentlyrequired for commercial interferon beta.
ABOUT MODIGENE
Modigene Inc. is a biopharmaceutical company applying its patented CTPtechnology to develop longer-acting, proprietary versions of already approvedtherapeutic proteins that currently generate billions of dollars in annualglobal sales. The CTP technology is applicable to virtually all proteins, andModigene is currently developing long-acting versions of human growth hormone,interferon beta and erythropoietin, which are in late preclinical development,as well as GLP-1. For more information on Modigene, visithttp://www.modigeneinc.com.
Safe Harbor Statement: This press release contains forward-lookingstatements, including statements regarding the results of current studies andpreclinical experiments and the effectiveness of Modigene's long-actingprotein programs and are made pursuant to the safe harbor provisions of thePrivate Securities Litigation Reform Act of 1995. Investors are cautionedthat forward-looking statements involve risks and uncertainties that mayaffect Modigene's business and prospects, including the risks that Modigenemay not succeed in developing any commercial products based upon itslong-acting protein technology, including any long-acting versions o
