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Estimated 2009 worldwide market of $4.8 billion
Interferon ß:
is a drug used to reduce the frequency and severity of relapses afflicting people suffering from multiple sclerosis ("MS"). MS is a neurological disorder affecting the brain and spinal cord, which over time leads to poor coordination, severe disabilities, and premature death. Annual sales of Interferon ß were estimated to be $4.3 billion in 2007, selling under product names Rebif, Betaseron (Betaferon), and Avonex by Merck-Serono, Inc., Schering, and Biogen Idec, respectively.
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PROLOR reported on January 25, 2010 positive results from a comparative study in primates of its longer-acting version of the multiple sclerosis drug interferon beta (IFN-beta-1a-CTP, referred to as IFN-beta-CTP). The study was designed to measure the potential increase in durability (half-life), overall drug exposure (AUC) and biological potency of PROLOR’s long-acting CTP-modified human interferon beta when compared with commercially available interferon beta.
The study results show that PROLOR’s CTP-modified IFN-beta, when compared with commercially available recombinant IFN-beta, showed 13 times prolonged durability (half-life), and 55 times prolonged overall drug exposure (AUC) in primates. IFN-beta-CTP also demonstrated strong biological potency as measured by several well-validated biomarkers including anti-viral activity and changes in neopterin, and 2’-5’ oligo A synthesase.
The expanded biological potency seen in this new study is consistent with the results of a previous study in mice conducted by PROLOR, which compared the anti-tumor activity of IFN-beta-CTP to commercially available IFN-beta in a model of human cancer. In that study, IFN-beta-CTP showed 100% inhibition of human melanoma tumors implanted in nude mice after eight days and 87.5% inhibition after 10 days, versus 50% inhibition with commercially available IFN-beta after eight days and just 12.5% inhibition after 10 days.
Many MS patients currently rely on IFN-beta to keep their disease in check, but to do so they must inject the drug frequently, with the attendant risk of adverse reactions that often accompany these injections. By potentially allowing these patients to dramatically reduce the required injection frequency and the injected dose, PROLOR believes that its IFN-beta-CTP could significantly enhance patients' quality of life.
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