Synthetic Blood gets OK to begin bypass surgery registration trial in Mexico

By E. Janene Geiss

Philadelphia, June 19 - Synthetic Blood International, Inc. said Monday that it received a letter of intent from the Mexican government Institute of Social Security, confirming its agreement in principle to conduct a clinical study in cardiopulmonary bypass surgical procedures with Oxycyte to support market approval in Mexico.

This agreement calls for Synthetic Blood to work with the government through a Mexican partner in conducting a 50-patient cardiopulmonary bypass surgery registration trial, including providing Oxycyte and overseeing a U.S. clinical research organization that will monitor the study, according to a company news release.

The IMMS will oversee the clinical study and prepare the required documentation for the application submission to the Mexican Ministry of Health, officials said. The IMMS also has indicated interest in exploring Oxycyte applications in additional medical procedures, including trauma and ischemia.

Synthetic Blood is responsible for obtaining funding for the trial. No sources of funding have been identified yet, officials said.

The Mexican government requires that non-Mexican based companies establish a partnership with a Mexican entity to conduct clinical trials and obtain product approval in Mexico.

Synthetic Blood has identified a potential Mexican partner to obtain approval and distribute Oxycyte for use in cardiopulmonary bypass surgery in Mexico.

The company said this clinical trial will be the first Oxycyte study in cardiopulmonary bypass surgery patients.

Oxycyte is the company's proprietary perfluorocarbon therapeutic oxygen carrier and blood substitute.

A first-generation PFC blood substitute manufactured in Russia, Perftoran, is approved for use in Mexico.

Synthetic Blood said it believes that its third-generation PFC Oxycyte offers significant advantages over Perftoran, including superior safety, oxygen delivery and efficacy.

The company said it is reviewing key elements of the Perftoran cardiopulmonary bypass protocol in developing its protocol for the planned Oxycyte study. Synthetic Blood also may request input from the Food and Drug Administration prior to protocol submission to the IMMS, officials said.

The Oxycyte trial in cardiopulmonary bypass surgical procedures is expected to be conducted at two large hospitals in Mexico City. Clinical endpoints for this trial will include safety, oxygen delivery, maintenance of good hemodynamics and avoidance of packed red cell administration.

Synthetic Blood is a Costa Mesa, Calif., biopharmaceutical company focused on oxygen therapeutics and continuous substrate monitoring.

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