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In addition to commercializing our core drug candidates, we are pursuing licensing deals with biotechnology companies that have a strategic interest in using our platform technologies to develop longer-acting versions of proteins, peptides or small molecule drug candidates:
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CTP Platform: Applicable for most proteins & peptides
Among these proteins:
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Interferon ß: The protein 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 $5.3 billion in 2010, selling under product names Rebif, Betaseron (Betaferon), and Avonex by Merck-Serono, Inc., Schering, and Biogen Idec, respectively.
PROLOR reported 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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Erythropoietin: Estimated 2010 worldwide market of $10 billion
The level of red blood cells in the body at any given time depends on a hormone called Erythropoietin (EPO). The kidneys make EPO and it travels to the bone marrow, where it stimulates the production of red blood cells. Individuals with chronic kidney failure, chemotherapy patients and HIV/AIDS patients on AZT suffer from low levels of EPO.
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Interferon α: The protein interferon α, produced by animal cells when they are invaded by viruses, is released into the bloodstream or intercellular fluid to induce healthy cells to manufacture an enzyme that counters the infection. Interferon has been approved for therapeutic use against hairy-cell leukemia and Hepatitis C. It has also been found effective against chronic Hepatitis B, a major cause of liver cancer and cirrhosis, as well as for treatment of genital warts and some rarer cancers of blood and bone marrow. Selling under product names Intron and PEGIntron by Schering-Plough and Roferon and Pegasys by Roche.
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Granulocyte Colony Stimulating Factor (G-CSF): stimulates the body’s bone marrow to make more of a crucial type of white blood cells called neutrophils. G-CSF is administered to patients undergoing chemotherapy who develop a low neutrophil count (neutropenia), which puts them at risk for severe infections and may mandate interruptions in cancer treatment. G-CSF is administered daily via injection. G-CSF, marketed by Amgen as Neupogen/Neulasta and by Chugai Pharmaceutical Co., Ltd. as Granocyte in Europe, had estimated 2004 worldwide sales in excess of $4.4 billion. Amgen received approval for Neulasta, a longer-lasting (PEGylated) version of Neupogen, in January 2002.
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Interleukin 11: is a protein that stimulates the production of platelets, which are important for proper clotting of the blood and wound healing. Interleukin 11 is used to increase platelets and decrease the need for platelet transfusions following treatment with certain cancer chemotherapy medications in patients who are at high risk of severely low platelet levels. Interleukin 11 is currently manufactured and marketed under the name Neumega by Wyeth.
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Fab antibody fragments:
are the targeting segments of monoclonal antibodies, and have an exceptional target binding affinity and specificity. They can be attached to various drugs that need "transportation" to certain biological targets. However, the Fab antibody fragments have a very short life span, and as a result are typically not suitable for many applications. We believe the CTP technology can prolong the life span of these Fab antibody fragments, enabling them to become therapeutic alternatives. Because we have an exclusive license to all available Fab antibody fragments, we can choose the most promising candidates from a pool of hundreds of Fab antibody fragments for development.
RevPEG Platform: Applicable for peptides & small molecules, with a specific emphasis on drugs that need to cross the blood-brain barrier
Therapeutic peptides: Globally, more than 40 peptide-based products having an annual sales volume of more than $ 5 billion are commercially available. Most of therapeutic peptides such as Somatostatins, Vasopressins, Platellet aggregate inhibitors, Calcitonins, GNRH/LHRH and Immunopeptides have very short durability and need to be injected on a daily basis.