Modigene has four CTP-enhanced compounds in development at its laboratory in Israel.No one likes getting jabbed, but for many there isn’t a choice. Millions of people get daily injections of therapeutic proteins, a group that encompasses everything from insulin to fertility drugs.

The problem faced by patients enduring multiple injections is how to get these therapies to last longer. The danger faced by drug developers wishing to increase “persistence”, is that the body will develop an immune response to the molecule, rendering it useless.

Therapeutic proteins are defined as proteins engineered in the laboratory for pharmaceutical use. These fall roughly into two categories: replacement therapies for people whose bodies can’t produce the proteins or produce insufficient amounts; and therapies that don’t exist naturally in the body but – as in the case of monoclonal antibodies – can be cloned from a single cell to bind to and destroy antigens.

Once in the bloodstream, therapeutic proteins are quickly broken down and filtered out, so injections must be administered frequently to be effective.

Israel’s Modigene, which just raised an additional $12 million from its investors, deals with replacement and enhancement therapies, and intends to develop longer acting versions of already-approved therapeutic proteins that will dramatically reduce the number of injections needed (i.e. from daily to weekly or less).

To that end, Modigene licensed intellectual property (IP) from Washington University of St. Louis. The technology is based on a short amino acid sequence, the carboxyl terminal peptide (CTP) that occurs naturally in humans. When attached to a therapeutic protein, CTP extends the time the protein is active in the body.

Modigene’s license is for rights relating to human therapeutics including all therapeutic proteins and peptides, excluding four endocrine proteins. These were licensed, for fertility applications only, to Dutch company Organon, a unit of Schering-Plough. Organon’s Phase II trials are encouraging: CTP follicle stimulating hormone product (FSH-CTP) required only one injection, compared with seven injections required for regular FSH.

The two companies are the only licensees of the technology, notes Modigene president Shai Novik, and while there is no formal relationship, “We follow them very closely because they are a clinical validation of the technology. We use the exact same CTP peptide but they are fusing it to FHS and we fuse it to other molecules.”

Modigene currently has four CTP-enhanced compounds in development: MOD-701 – Erythropoietin to stimulate red blood cell production; MOD-901 – Interferon ß to treat multiple sclerosis (MS); MOD-1001 – GLP-1 for treatment of Type 2 diabetes and MOD-401 – Human Growth Hormone, to treat children with growth hormone deficiency, kidney disease, Prader-Willi Syndrome, and Turner’s Syndrome. Israel’s Office of the Chief Scientist awarded Modigene development grants for HGH-CTP in 2007 and for EPO-CTP in 2006.

HGH-CTP could have an additional market; it is being touted as a fountain of youth for adults that could increase energy, enhance sexual performance, lower cholesterol, and plump aging skin.

Novik says Modigene is watching but not targeting the lifestyle market, preferring to stay on track for FDA approval with human trials for HGH-CTP scheduled for the first quarter of 2009, and hopes of market launch in five years. “That’s not a long time for drug development as we’re seeking approval for an existing drug. Fast time-to-market at lower cost is part of our strategy.”

In addition to commercializing its core therapeutic proteins, Modigene is also seeking licensing deals with biotechnology companies interested in developing longer-lasting versions of their existing drugs.

Modigene, which is publicly traded on Wall Street (MODG), operates an R&D subsidiary at the Weizmann Science Park, Ness Ziona.

Modigene’s chairman and lead investor is Miami-based entrepreneur Dr. Phillip Frost, listed among Forbes 400 Richest Americans for 2007. Frost is chairman of Ladenburg Thalmann & Co. Inc. and a director of Continucare Corp. (CNU) and Teva Pharmaceutical Industries.

The $12 million investment consists of a $2 million equity investment by Frost, Dr. Jane Hsiao and Steven Rubin, who are also directors at Modigene and members of The Frost Group LLC, which extended the additional $10 million line of credit.


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