Auckland, NZ (11 November, 2011): Innate Immunotherapeutics today announced that the dose confirmation part of the companys Phase 2A trial of drug candidateMIS416 in patients with the progressive form of MS will commence in earlyJanuary 2012.
The announcement follows the successful conclusion of a doseescalation study in 16 patients with either primary progressive or secondaryprogressive MS conducted at Primorus Clinical Trials (Christchurch, NZ). The upcoming dose confirmation study willtest a potentially therapeutic dose level of MIS416 in 15 patients withsecondary progressive MS over a three month period.
Both parts of the 2A study are designed to establish the safetyand tolerability of Innate Immunotherapeutics immune modulating microparticleand to also establish a dose level to be trialed in a larger scale Phase 2Bclinical trial in late 2012.
The current trial is being partly sponsored by the U.S.National MS Society Fast Forward programme in collaboration with Merck Seronoand has also attracted significant support from the New Zealand GovernmentsMinistry of Science and Innovation.
Innate Immunotherapeutics CEO, Simon Wilkinson, said the Company was delighted to have successfully completely the first part of the study and paid tribute to the patients and trial centre staff. "This study commenced just two weeks after the major earthquake that struck Christchurch on September 4th last year. Since that time there have been over 8,000 aftershocks including major quakes on Feb 22nd and June 13th. Despite the significant disruption caused to the Christchurch infrastructure and peoples lives, both patients and staff have soldiered on and been unwavering in their support of the study. We are indebted to them."