Ark Therapeutics is reprioritizing its product development programs and looking to cut jobs to preserve cash in light of the December 2009 decision by the EMEA’s Committee for Medicinal Products for Human Use (CHMP) not to recommend EU approval of its malignant glioma gene therapy Cerepro®. Ark says the restructuring and reprioritization measures should ensure it has enough cash to fund continued operations into the second half of 2011.
Ark has already formally requested that the EMEA re-examine the MAA for Cerepro but is making additional moves to help save money in the interim. These include putting further Phase III development of its cancer cachexia drug candidate, Vitor™, on hold. The decision is possibly based on the results from a pilot Phase III trial, which flagged the need to change the trial design and entry criteria.
An interim analysis of the first 22 non-small-cell lung cancer patients from this study showed no benefits of Vitor, a lipophilic ACE inhibitor, on cancer-related weight loss, as neither the treatment nor the control groups showed weight loss in the 12-week treatment period. The pilot Phase III trial design differed from a previous Phase IIb/III study, particularly with respect to the introduction of a 2–6 week study run-in period.
The company will, however, continue Phase III development of Trinam®, a gene-based medicine to prevent blood-vessel blocking in kidney-dialysis patients who have undergone vascular access graft surgery. Trinam started in a U.S. Phase III trial in May 2009.
Ark says that it also aims to push on with taking its key preclinical programs into Phase I/IIa development. These include EG011 in refractory angina, EG016 in peripheral vascular disease, and EG013 in fetal growth retardation. The company also confirmed the start of Phase I/IIa trial of adenoviral short-form vascular endothelial growth factor-D in patients with refractory angina as part of the EG011 program.
“With the delay announced in December, it is sensible to take steps to ensure we have a longer cash horizon and can protect the core assets of the business in order to hit the crucial value-creating milestones,” admits Martyn Williams, CFO.
The firm also stresses that its achievement of an approvable gene medicine platform means that the Cerepro hiccup should not have any long-term detrimental effects on the company’s prospects. “The success with the technical aspects of Cerepro and particularly the establishment of an approvable adenoviral gene medicine platform have allowed us to take these measures without significantly impacting our future gene medicine business, short-to-medium term,” claims Nigel Parker, Ph.D., the company’s CEO.