A Medical Device Daily
Biopharmaceutical company Corautus Genetics (Atlanta) said it has responded to the FDA's halt of its GENASIS (Genetic Angiogenic Stimulation Investigational Study) Phase IIb clinical trial, for vascular endothelial growth factor-2 (VEGF-2), a chest-pain drug, after some patients suffered adverse events.
The drug maker said it has been working with Boston Scientific (Natick, Massachusetts), which makes the Stilleto catheter used to deliver the drug, over the past several weeks to evaluate the adverse events.
Richard Otto, president and CEO of Corautus, said in a prepared statement that the company believes it has appropriately investigated the events that led to the trial suspension and has “developed a plan for dealing with these issues in potential subsequent clinical trials evaluating VEGF-2 for the treatment of severe angina.”
Corautus insisted that three incidents of pericardial effusion, a condition where excess fluid builds in the sac surrounding the heart, were not related to the drug. The company said it hopes to advance the drug into late-stage clinical trials.
According to Otto, the company looks forward to analyzing the GENASIS data and continuing discussions with the FDA to determine an appropriate primary endpoint in a trial for the treatment of patients suffering from severe angina.
“We continue to be hopeful the information generated by our analysis may support the commencement of a Phase III clinical trial,” said Otto.
In April the company voluntarily terminated patient enrollment in the GENASIS trial based on the recommendation of its independent data monitoring committee (DMC) (Medical Device Daily, April 11, 2006).
The trial had enrolled patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures and had involved the injection of genes – specifically VEGF-2 – into the heart to stimulate the formation of new blood vessels via a process known as therapeutic angiogenesis.
The DMC recommended to the company that, based on available efficacy data, enrollment should be terminated under the current protocol since, the DMC said, it saw “very little chance for significant efficacy” as to the primary endpoint relative to the safety/risk signal it saw.
Trial termination followed enrollment suspension by the company on March 14 to investigate the three aforementioned recent serious adverse events that the company said it did not believe were associated with the biologic (MDD, March 15, 2006).
Otto said the rate of tamponade events experienced in the GENASIS trial was 1.36% or 4 out of 295 patients treated. The trial had planned to enroll a total of 404 patients at 30 centers in the U.S.
The company currently has a distribution and development agreement with Boston Scientific for use of VEGF-2 in a delivery platform for the treatment of cardiovascular disease.
Via that arrangement, first disclosed mid-2003 (MDD, Aug. 1, 2003), Boston Sci acquired a 17% stake in the company, with the most recent stock purchase of 4.3 million Corautus shares valued at about $18 million having taken place this past June (MDD, June 9, 2005).