Lancet: New Drug Arrests Progression of Type 1 Diabetes

Contact: Dennis Tartaglia/Dana KoppM Booth & Associates(212) 481-7000 [email protected]

LANCET STUDY SHOWS DiaPep277 ARRESTS PROGRESSION OF TYPE 1 DIABETES Drug Preserves Insulin-Producing Cells, Reduces Amount of Injected Insulin Needed

REHOVOT, Israel/ERKRATH, Germany/LONDON, England -- Experimental drug DiaPep277 has been shown in a Phase II human clinical trial to arrest the progression of type 1 diabetes, prevent destruction of insulin-producing pancreatic cells, and reduce the need for injected insulin in newly diagnosed patients. Results of the study are published in the November 24, 2001 issue of The Lancet. The study was funded by Peptor, the biopharmaceutical company that is developing DiaPep277.

"Our research has shown that it is possible to modulate the immune system and prevent or stop it from attacking the insulin-producing cells," said Dana Elias, Ph.D, Vice President, Research & Development, Peptor and lead investigator on the study. "DiaPep277 holds the promise of becoming a breakthrough therapy for those already diagnosed with autoimmune diabetes, and perhaps a preventive treatment for those at high risk for the disease. If we reach patients early we may be able to improve the quality of their lives by significantly reducing their dependence on insulin. We may also halt or delay the development of complications and, possibly, extend patients' lives."

Type 1 diabetes (formerly known as juvenile diabetes or insulin dependent diabetes mellitus) is a condition in which the immune system attacks and destroys insulin-producing beta cells in the pancreas. This attack renders the pancreas unable to produce insulin, a hormone that controls blood sugar levels. People with type 1 diabetes must take insulin shots several times a day in order to survive. Late stage complications frequently include heart disease, stroke, high blood pressure, blindness, kidney disease, nervous system damage, amputations, dental disease, and pregnancy complications. People with this condition have a lifespan that is, on average, 15 years shorter than the norm.

Dr. Elias and colleagues at Peptor, along with research teams at Hadassah-Hebrew University Medical School and the Weizmann Institute of Science, conducted a ten-month randomized, double-blinded study of 35 men recently diagnosed with type 1 diabetes. Eighteen patients received injections of DiaPep277 at the beginning of the study, at one month, and at six months; 17 patients received three injections of an inert substance (placebo) at the same intervals (15 DiaPep277 patients and 16 placebo patients completed the study). All patients continued to take daily insulin injections.

At ten months, average concentrations of C-peptide -- a protein (cleaved off pro-insulin) used to measure the body's own insulin production -- in the placebo group had fallen significantly -- from 1.12 to .26 nmol/L -- while these levels increased from .66 to .93 nmol/L in patients receiving DiaPep277. The need for insulin injections increased significantly over 10 months from .37 to .67 U/kg daily in the placebo group. In the DiaPep277 group, average insulin needs increased from .34 to .43 U/kg, a statistically insignificant amount. C-peptide concentration differences between the treatment groups were statistically significant at 7 and 10 months and differences in insulin requirements were statistically significant at 10 months.

Dr. Elias' team also found that patients receiving DiaPep277 produced more interleukin 10 and interleukin 13, hormone-like cytokine proteins that inhibit inflammation. Researchers did not observe any adverse effects.

DiaPep277 is a synthethic version of p277, a peptide derived from hsp60, a 60kDa heat shock protein. Heat shock proteins are present in all of the body's cells, and are produced in large numbers when the cells are stressed -- or shocked. The proteins are molecular chaperones -- they "mop up" damaged peptides and carry them into the body's "junkyard."

Peptor's research indicates that DiaPep277 triggers regulatory T cells. These T cells secrete anti-inflammatory natural hormones, referred to as cytokines, that can turn off the misdirected immune cells, thereby stopping their attack and destruction of healthy beta cells. In animal studies funded by Peptor, DiaPep277 has shown a significant reduction in inflammation of the pancreas with continued insulin production, suggesting that the progression of the disease may be prevented. This change in the immune response is diabetes-specific, suggesting that the development of a disease-specific treatment that re-educates the human immune system -- without suppressing the entire system and leaving the patient open to infection and other complications -- is possible.

Peptor is conducting five international multicenter Phase II clinical studies of DiaPep277 in type 1 diabetes patients as well as one international multicenter Phase II clinical study in patients with latent onset of autoimmune diabetes in adults ("LADA"), and is preparing to begin Phase III clinical studies. LADA occurs after age 40 in adults with type 2 diabetes. While type 2 diabetes can generally be controlled without insulin injections, people with LADA develop the same autoimmune reaction against their beta cells as in type 1 diabetes and must begin daily insulin injections in order to maintain normal blood sugar levels.

There are an estimated 10 million people in the United States, Europe, and Japan with autoimmune diabetes (including type 1 diabetes and LADA). There is currently no way to treat the underlying cause of autoimmune diabetes or to halt the progression of the disease. Even with the use of external insulin, type 1 diabetes and LADA usually result in a drastic reduction in quality of life and late stage complications.

Peptor, Ltd., is a biopharmaceutical company engaged in the discovery and development of breakthrough drugs to cure autoimmune diseases. Unlike other companies in this treatment arena, Peptor has one important drug in later stage clinical development for autoimmune diabetes and a second drug candidate for myasthenia gravis ready to go into clinical trials. A third drug candidate -- for diabetic nephropathy -- is also entering clinical trials. Peptor's therapeutic approach is based on two platforms: heat shock protein technology and combinatorial peptidomimetic chemistry utilizing proprietary technology that enables Peptor to rationally design, synthesize and screen large numbers of low molecular weight compounds as potential drug candidates. Peptor has a number of autoimmune drugs in its research pipeline and anticipates using its technologies to develop cancer therapies as well. Founded in 1993, Peptor is based in Rehovot, Israel and Erkrath, Germany.

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