13/09/11 New Hope for Immune Therapy for Children with Type 1 Diabetes
Orban Biotech has announced that its C.E.O., Dr. Tihamer Orban, who was Principal Investigator for the Phase II clinical study run by TrialNet using Bristol Meyer’s Abatacept for the treatment of Type 1 Diabetes Mellitus, presented the results of the trial at this year’s American Diabetes Association meeting and the primary clinical findings have been published in the prestigious journal The Lancet.
Abatacept works by blocking the generation of destructive autoaggressive T cells, which in Type 1 diabetes rapidly destroys the insulin-producing beta cells. In The Lancet, Dr. Orban and his colleagues reported that Abatacept therapy substantially slowed the decline of self-insulin production; by 2 years the treated patients had 59% more self-insulin production. It also improved significantly the patients’ metabolic control, which is critical for reducing short-term and long-term complication of this serious disease. Importantly, unlike other immunosuppressive drugs which also tend to suppress the overall immune system with considerable side effects, Abatacept demonstrated significant benefit with excellent tolerability.
“Abatacept represents great hope for all those children and young adults with Type 1 diabetes who are in need of a therapy that attacks one of the major underlying mechanisms causing the destruction of beta cells,” stated Dr. Tihamer Orban, Orban Biotech’s Founder and Chief Executive Officer. “I have spent my career on the quest to find a treatment and cure for Type 1 diabetes and thus it was very gratifying when we unblinded the clinical results and discovered that Abatacept had benefit. From my experience though, Abatacept is likely to not be the complete answer, and Type 1 diabetes patients will likely benefit from cocktail combinations with other drugs. While Abatacept inhibits the generation of T cells responsible for mounting the attack on the beta cells, its benefit could be greatly amplified by combining it with an autoantigen, like Orban Biotech’s insulin B chain vaccine which boosts regulatory T cells and keeps the autoaggressive T cells in check. This synergistic approach has a great future.”
Orban Biotech has launched a pre-clinical study evaluating the combination of its insulin B chain vaccine with Abatacept. Orban Biotech insulin B chain-based vaccine has already demonstrated safety in a Phase I trial and the drug provided hints of clinical efficacy by strengthening the much-needed immune regulation in a very disease-specific manner. Orban Biotech is poised to launch a Phase II trial to develop this non-immune-suppressive antigen-based therapy.
Presently there is no cure or approved treatments for T1DM autoimmunity. T1DM primarily strikes out at children and the autoimmune destruction results in a lifelong dependence on daily injections or infusions of insulin. Those afflicted with T1DM face the challenge of tightly controlling blood sugar to minimize acute and late, often life threatening complications.
Orban Biotech’s insulin B chain vaccine targets the root cause of T1DM itself: the loss of self-tolerance and the resultant progressive destruction of insulin-producing beta cells. The loss of self-tolerance to insulin, a primary autoantigen in T1DM unleashes autoaggressive T cells and initiates the autoimmunity. The Company’s insulin B chain vaccine is designed to function by re-establishing self-tolerance towards insulin, thus arresting autoimmune destruction and preserving self-insulin production. This approach is especially desirable and well suited for young children because the drug is type 1 diabetes specific with the capacity to induce self-tolerance without suppressing the immune system. The Phase I study (Published in the October 2009 Journal of Autoimmunity) demonstrated safety and the vaccine induced a desirable, robust and lasting immune response in the treatment group.
About Orban Biotech (www.orbanbiotech.com)
Based in Brookline, MA, Orban Biotech is a clinical stage biotechnology company founded with the clear mission of developing and commercializing a novel therapeutic vaccine for Type 1 Diabetes Mellitus (T1DM) and other autoimmune disorders. The Company’s insulin B chain vaccine is result of the many years of research by Dr. Tihamer Orban and his former colleagues at the Joslin Diabetes Center aimed at gaining a better understanding of the immulogical mechanisms underlying T1DM. The Company overriding goal is to find a cure or therapy for T1DM to help improve the quality of life for children afflicted by this disease by working “with the patients for the patients.”
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