News Headlines:
March 9, 2010:
Ischemix Initiates Phase 2a Clinical Trial
March 18, 2009:
DuFresne Joins Ischemix as CEO
August 13, 2007:
Ischemix Completes Phase 1 Clinical Trial
April 5, 2007:
Ischemix Initiates Clinical Development
News
Ischemix Initiates Phase 2a Clinical Trial
March 9, 2010
Ischemix announced the initiation of patient accrual in a multi-center Phase 2a clinical trial of CMX-2043 for the prevention of peri-operative ischemia-reperfusion injury in patients undergoing elective percutaneous coronary intervention (PCI) procedures. CMX-2043 is a cardio-protective drug that combines Akt pathway-mediated cell survival effects and anti-oxidant activity in a single small molecule. The Phase 2a trial is a prospective, randomized, double-blind, placebo-controlled study that will compare three different intravenous dosing levels of CMX-2043. The primary outcome of the trial is the safety of CMX-2043 injection, as measured by changes in Creatine-Kinase-MB (CK-MB) and troponin, biomarkers of cardiac damage. Secondary outcomes will evaluate the efficacy of CMX-2043 based on changes observed in these cardiac biomarkers and via continuous electrocardiographic monitoring. The study will also explore the correlation between biomarker changes and the pharmacokinetics of the drug.
DuFresne Joins Ischemix as CEO
March 18, 2009
Duffy DuFresne, a seasoned biotech and pharmaceutical executive, has joined the Ischemix team as Chief Executive Officer. Mr. DuFresne has been a member of the Board of Directors since May, 2007. His background ranges from guidance of pre-clinical and clinical development programs, through licensing and funding, and into product launch and growth. His past ten years as CEO at Conjuchem, Zelos Therapeutics and Pacgen BioPharmaceuticals were attended by marked success. (see here for his biography).
Ischemix Completes Phase 1 Clinical Trial
August 13, 2007
Ischemix, a privately held pharmaceutical company has completed
Phase 1 Human Safety Studies of its drug candidate, CMX-2043.
This double-blind escalating-dose trial in healthy volunteers showed
no evidence of treatment-related adverse events at doses up to five
times those anticipated to be effective in cardiac surgery patients.
Based on this excellent safety profile, the company is now moving
forward into studies in cardiac surgery patients.
CMX-2043 clinical development is initially targeted at prevention
of complications associated with Coronary Artery Bypass Graft (CABG) surgery.
Although CABG surgery is routine and performed approximately
500,000 times per year in the US, many patients have a significant
complication after the procedure. The cost of such complications
can be tens of thousands of dollars in extra procedures, ICU,
and hospital stay per patient.
Ischemix is located in Maynard, MA. Its capabilities include chemical synthesis and analysis laboratories as well as facilities for cell culture and biological research. The company has contractual relationships with synthetic, analytical, manufacturing, preclinical and clinical organizations across the United States and in India.
Ischemix Initiates Clinical Development
April 5, 2007
The U.S. Food and Drug Administration (FDA) has given Ischemix permission to begin human studies with CMX-2043, the company's new drug designed to protect the heart from damage associated with coronary artery bypass graft (CABG) operations. This novel compound includes both anti-oxidant and calcium regulating activities which act together to reduce ischemia-reperfusion injury.
Each year about half a million Americans undergo surgical procedures to provide a new blood supply when arterial blockage or narrowing starves the heart muscle of oxygen and essential nutrients. But complications are common and may include new heart attack, stroke and rhythm disturbances. In pre-clinical studies CMX 2043 has been shown to protect heart muscle and brain, and reduce the incidence of arrhythmia.
Ischemix's Investigational New Drug (IND) application included safety and efficacy data, and a protocol for the initial human studies. The FDA approved the application by letter today. This important milestone moves Ischemix from the research phase into clinical development of a drug responding to a major unmet medical need. The first-stage human studies are planned to begin within a month and are expected to continue for 3 months.