Diamyd completed screening for US Phase III study in type 1 diabetes. The screening of patients for the US Phase III study, DiaPrevent, was completed, ending the recruitment campaign. More than 310 recently diagnosed type 1 diabetes patients between 10 and 20 years of age had, at the completion of screening, been enrolled in the study and received their first injection of the antigen-based therapy Diamyd?® or placebo.
Phase I trial in chronic pain showed pain relief. Substantial and sustained reduction in experienced pain were reported in the two highest dose cohorts of Diamyd Medical’s Phase I trial investigating NP2 Enkephalin as a potential therapy for chronic pain. The Phase I study is intended to test the safety of NP2 Enkephalin and the NTDDS platform. In addition to safety data, measurements of pain relief and concomitant pain medications were compiled. The clinical trial was designed as an open label, dose escalation study in patients with intractable pain due to malignant cancer. Three dose levels were investigated and eight patients were evaluable at the four week study time point.
Diamyd reported promising safety findings from Phase I study in chronic pain. No drug related Serious Adverse Events have been reported by any patient included in Diamyd’s Phase I clinical trial investigating NP2 as a potential therapy for chronic pain.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
Diamyd started Phase II study in cancer pain. The Phase II clinical trial with the candidate drug NP2 Enkephalin will recruit approximately 32 subjects with severe cancer pain and follow their pain scores and concomitant pain medication usage. It is a multi-center, randomized, double-blind, placebo controlled study designed to provide a statistical evaluation of pain relief. The trial has a four week double-blind main study period and following this period, all patients will be offered up to two additional doses of active NP2 Enkephalin in an open label study extension.
The Diamyd share moved to NASDAQ OMX Stockholm Mid Cap list. NASDAQ OMX Stockholm decided to move Diamyd Medical (DIAM B) from the Small Cap list to the Mid Cap list. The change was effective as of January 3, 2011. The Mid Cap segment includes companies with a market capitalization of between EUR 150 million and EUR 1 billion.
NASDAQ OMX Stockholm Disciplinary Committee imposed a penalty on Diamyd Medical AB for inadequate disclosure of information. In a letter dated November 5, 2010 to the Disciplinary Committee of NASDAQ OMX Stockholm, NASDAQ OMX Stockholm AB requested that the Disciplinary Committee issue a decision on disciplinary action regarding Diamyd Medical AB’s disclosure of information. Diamyd Medical AB received the Disciplinary Committee’s decision on December 15, 2010, instructing Diamyd Medical AB to pay an administrative penalty of SEK 576,000, corresponding to three annual fees.
SOURCE Diamyd Medical