Medical Device Daily
Corautus Genetics (Atlanta) yesterday reported that in consultation with development partner Boston Scientific (Natick, Massachusetts), it has temporarily suspended patient treatments in its GENASIS Phase IIb clinical trial investigating the use of its VEGF-2 biologic using Boston Sci's Stiletto catheter.
Also, as a result of the suspension of the trial, Corautus and its underwriters have agreed to terminate the company's previously reported public offering of common stock. The company last month priced an offering of 7.5 million shares at $3.85 a share in proposing to raise about $26.5 million, with additional sale of over-allotments to investors (Medical Device Daily, March 13, 2006).
The trial being conducted by Corautus uses Boston Sci's Stiletto endocardial direct injection catheter system to deliver its investigational VEGF-2 biologic for the treatment of severe angina.
Corautus said that Boston Scientific requested the voluntary suspension as a result of recently reported serious adverse events (SAEs) of pericardial effusion. It said that these SAEs “do not appear to be related to the VEGF-2 biologic.“
In a morning conference call, Richard Otto, president and CEO of Corautus, said that three SAEs had appeared in a “cluster“ over the last 10 days requiring “secondary intervention.“ Previously in the trial there had been four such events but with only one requiring a secondary intervention.
However, he said that the recent cluster of three SAEs, “gave us cause to pause and take a look at what may be causing this.“
He described the pericardial effusion SAE as the appearance of excess fluid – from 100 cc to 350 cc, in these cases – in the pericardial sac that surrounds the heart and thus inhibiting its ability to beat properly. The percentage of cases requiring further intervention due to pericardial effusion in the GENASIS trial to date has been 1.37%.
He said that both Corautus and Boston Scientific are analyzing the problem, but he more than once indicated that a lack of comparative data – due to the innovative nature of the trial itself – made the analysis difficult.
He also noted that patient safety was of key importance, and thus the company wanted to do “what is right, not what is popular or what is speedy.“ And he expressed confidence that the trial could be restarted “promptly.“
So far 295 patients have been enrolled, of 404 patients scheduled to participate.
In a company statement, Otto said: “Boston Scientific has been an excellent and quality collaborator throughout this trial, and they have pledged an expeditious and thorough review of any issues identified on the catheter system or its use in our trial. We look forward to resumption of treatment of the remaining patients in the GENASIS trial.“
The other issue addressed in the conference call was the halt of the stock offering.
The company reported $30.9 million in cash and short-term investments. It said that this was sufficient to take it through the first quarter of 2007 with a burn rate from $1.5 million to $2 million a month.
Bob Atwood, company CFO, said that while the trial halt might result in “some variation“ in monthly burn rate, the company thus far was not “factoring in any major change.“
Corautus originally teamed up with Boston Scientific on the angina application effort in 2003, with Boston Scientific acquiring 10% of Corautus stock for $9 million and committing to up to $15 million more in milestone payments, depending on the progress of the investigation (MDD, Aug. 1, 2003).
Key to the study is the delivery of a gene with the catheter approach without deactivation of the gene, considered a major problem to be overcome in such an approach, the companies said at the time.