ZICHRON YAAKOV, Israel ¿ Just one injection every two months might be able to replace the multiple injections needed daily for juvenile-onset diabetes patients, with the vaccine DiaPep277.

This experimental vaccine was shown to arrest progression of Type I diabetes in newly diagnosed patients, without displaying any harmful or significant side effects. Just three injections in six months were required to halt disease progression and the effect has continued for nearly a year.

Due to the these strong results, Peptor Ltd. in Kiryat Weizmann Science Park is requesting approval from the FDA to initiate Phase III trials before completion of Phase II, which will continue through 2002, said Dana Elias, vice president for research and development at Peptor. The drug, based on a small peptide fragment called p277, was discovered by Weizmann scientist Irun Cohen and Elias, when she was his doctoral student.

Cohen said, ¿The idea to use p277 against diabetes stemmed from the discovery that the immune system responds to an antigen by destroying it or by protecting receptor cells from destruction. In this case, it prevents the pancreatic cells from being destroyed.¿

Peptor purchased the licensing rights to DiaPep 277 in 1998 following the ¿dramatic results on a mouse model,¿ and ¿the team proceeded to show its efficacy on patients, 200 of whom have been treated in Phase II studies in Bulgaria, Hungary, Slovenia and Israel, and are starting in Germany, the United Kingdom and Italy,¿ Elias said.

¿A significant amount of the $70 million capital raised over four funding rounds has been devoted to our antidiabetes drug,¿ Elias told BioWorld International.

One of the Phase II trials at Jerusalem¿s Ein Kerem Hadassah-University Medical Center was led by Itamar Raz, head of the hospital¿s diabetes unit, the results of which were published in the Nov. 24, 2001, edition of The Lancet.

In this Phase II double-blind study, 35 males aged 16 to 55, newly diagnosed with Type I diabetes, received injections at the study onset, at one month, and at six months. Eighteen patients received DiaPep277, and 17 received three placebo injections.

¿DiaPep277 blocks the immune system¿s ability to destroy insulin-producing pancreatic beta cells in humans, allowing us to both prevent disease onset in people at genetic risk and also to halt diabetes progression even after pancreatic cells have begun to die,¿ said Raz, president of the Israel Diabetes Association, speaking to BioWorld International from Vienna about their follow-up examinations 10 months after the initial injection. ¿The patients¿ level of native insulin production increased and thus they needed fewer or no insulin supplements.¿

Raz added, ¿Some 15 agents have been found to halt destruction of beta cells in mice, but none before have worked in humans. No one believed it would work in people, and we labored against a lot of skepticism.¿

Peptor¿s technology platform enables drug production using small cyclic analogues of peptide loops, which are easier and cheaper to manufacture than entire proteins, more stable and more effective with fewer side effects, Elias said.

Peptor, which was established in 1993, has 51 employees, with 44 working in its independent subsidiary in Erkhirt, Germany.