DIAMYD GETS AUTHORIZATION TO BEGIN PHASE III STUDY IN THE US
Press Release, Stockholm, Sweden, March 14, 2008 – Diamyd Medical AB (www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker DMYDY)
Diamyd Medical announced today that the FDA has given the Company permission to start a Phase III clinical study in type 1 diabetes patients in the US.
“We are eager to start this study and to be able to offer this promising drug to our newly diagnosed type 1 diabetes patients”, says Professor Jerry Palmer, University of Washington in Seattle, USA, who will be the Lead Investigator for the US study.
“We are extremely pleased with the regulatory process, that has now enabled us to go ahead with the Phase III trial in the US,” says Elisabeth Lindner, president and CEO of Diamyd Medical. “Over the past months we have received dozens of patient inquiries with requests to participate in our Phase III type 1 diabetes studies in the US and in Europe. It is very satisfying to be able to start the studies now.”
The US Phase III study will enroll 306 new-onset type 1 diabetes patients, who are within 3 months of diagnosis. In one arm of the study, 102 patients will receive a 20 µg injection of Diamyd® on study days 1 and 30 to confirm earlier Phase II results. In a second arm, 102 patients will receive a 20 µg injection of Diamyd® on days 1 and 30, and then additional doses on days 90 and 270 to investigate the potential long-term beneficial effect of extra doses. In the third arm of the study, 102 patients will receive placebo. Results of the study will be analyzed 15 months after all patients have received their 1st injection. A parallel similar Phase III study is planned to be conducted in Europe and together, pending a positive outcome of the trials, the studies can be used for market registration of the drug.
In a previous Phase II study in young type 1 diabetes patients, the Diamyd® diabetes vaccine showed efficacy in preserving the patients’ own insulin producing capacity for at least 30 months. No safety concerns have to date been reported in any clinical study with Diamyd®.
“The Phase II study results are amazingly good, and they shall now be confirmed in the Phase III program”, says Professor Ludvigsson, Principal Investigator for the previous Phase II study in Sweden and the Principal Investigator for the upcoming European Phase III study. “It is the first time that we have been able to show a real effect on the progress of type 1 diabetes, without causing any side effects, and it gives true hope for patients. Saving insulin producing cells from being destroyed by the autoimmune process in type 1 diabetes is of great clinical value as it makes it easier for the patient to handle the disease with reduced acute and late complications.”