The high-risk area of new cardiovascular therapies has hit what appears to be another dry well.
Corautus Genetics (Atlanta) late Friday reported that it is abandoning further clinical trials of VEGF-2 for the treatment of cardiovascular and peripheral vascular disease and has released several members of its management team.
Corautus has been focusing on the development of gene transfer therapy products for the treatment of severe angina and peripheral vascular disease, with the goal of developing a gene therapy product candidate using the VEGF-2 gene to promote therapeutic angiogenesis in ischemic muscle, primarily in its Genetic Angiogenic Stimulation (GENASIS) trial.
The FDA in April blocked further enrollment in GENASIS following adverse patient events (Medical Device Daily, April 11, 2006), primarily three incidents of pericardial effusion in which excess fluid builds in the sac surrounding the heart.
The company responded saying it would pursue further analysis of the trial and gather additional data, and the FDA in July then put the trial on “partial hold” (MDD, July 14, 2006).
Its additional efforts have run aground, however, and in its statement on Friday it said it is “redirecting its focus to other life sciences opportunities.”
To preserve its remaining cash, it is releasing various executives and will use its remaining funds, it said, “to identify other life sciences technologies that it could acquire or in-license, or other life sciences opportunities.”
Corautus said that as of Sept. 30, 2006, it had cash and short-term investments of $19.7 million.
Corautus released Richard Otto, president/CEO, and Robert Atwood, executive vice president and CFO, terming these moves “separation agreements.” Both will cease being officers and employees of Corautus as of Dec. 31. However, Otto and Atwood will remain on the board and serve as part-time company consultants.
Jack Callicutt, currently vice president of finance and administration and chief accounting officer, has been named senior vice president, CFO and secretary of the company, as of Jan. 1. Corautus said it would conduct a search for a new CEO to succeed Otto.
Callicut told MDD that the company has not identified any new opportunities, as yet.
“We had initially started looking at other cardiovascular therapeutics during the summer and early fall, but found nothing that matched up well with our core competencies. We just decided to scale back operations and [reduce] cash burn until we can find something that fits,” Callicut said.
With last week’s decision, he said that Corautus will be “casting a broader net, using our board of directors — looking at cardiovascular, peripheral [artery disease], looking at a variety of tings.”
He said there have been no decisions made concerning a key gene licensing from Human Genome Sciences (Rockville, Maryland) or the catheter delivery device it was using in a partnership agreement with Boston Scientific (Natick, Massachusetts).
Boston Scientific’s involvement in the trial was critical since the company had committed, along with other investors, to investments in Corautus of up to $25 million.
“We’re not sure of [Boston Scientific’s] plans,” Callicut said, but added: “they have been very supportive since our collaboration began, and we’re working with them to tie up loose ends of the trial.”
The halt of the GENASIS trial also served to derail plans for an IPO by the company (MDD, March 15, 2006).
Corautus also reported the termination of employment agreements for Yawen Chiang, senior vice president and chief scientific officer; Michael Steele, vice president of business development; and Todd Stallings, vice president of clinical and regulatory, before Dec. 31. Chiang is expected to serve as a part-time consultant to the company thereafter.
The company had 13 employees on Oct. 31 and said it expects to “significantly reduce” those numbers by Dec. 31. In terms of those cutbacks, Callicut said, “We’re in that process now.”
Otto said, “We believe the GENASIS trial was one of the largest cardiovascular trials of its type that has ever been conducted. Much information was gathered which may assist in future scientific endeavors.
“As we previously reported, the trial did not meet its primary endpoint. We have examined the alternatives available to us and have concluded that further clinical trials of VEGF-2 at this time are not in the best interest of our shareholders.”
GENASIS was a randomized, double-blind, dose-ranging and placebo controlled Phase IIb clinical trial, which treated 295 patients with Class III or IV angina that were not suitable candidates for traditional revascularization. GENASIS was conducted at about 30 cardiac medical centers throughout the U.S.
In GENASIS, defined doses of VEGF-2 in the form of “naked” plasmid DNA, a non-viral delivery vector, were delivered to diseased heart muscle tissue via Boston Scientific’s Stiletto endocardial direct injection catheter system. The injection procedure was performed by a cardiologist in a standard cardiac catheterization laboratory.