Ark's Trinam(R) Awarded Fast Track Status By FDA

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals;  Vascular;  Genetics
Article Date: 07 May 2009 - 0:00 PDT

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Ark Therapeutics Group plc ("Ark" or "the Company") announces that Trinam® has been awarded Fast Track designation by the US Food and Drug Administration ("FDA"). Trinam® is Ark's novel gene-based medicine to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery. This designation covers Trinam® as a treatment for the prevention of de novo stenosis at vascular surgical anastamoses.

Designation as a Fast Track product allows the FDA to take such actions as are appropriate to expedite the development and review of the application for marketing approval of the product. The FDA may also evaluate for filing and commence early review of portions of an application for marketing approval of a Fast Track product under certain conditions.

Trinam® is an adenovirus-mediated VEGF D gene delivered with a novel biodegradable local delivery device (EG001) and is currently undergoing Phase III development in the US under Special Protocol Assessment ("SPA"). Results from a Phase II open-label, non randomised, standard-care controlled trial of Trinam®, reported in March 2007, indicated that the access grafts of patients given Trinam® remained functional for dialysis, on average, up to three times longer than in untreated controls. Trinam® was well tolerated with no quantifiable systemic distribution of the product found and no serious side effects were exhibited other than those consistent with the nature of the operation and condition.

US regulatory review for the product comes under the responsibility of the Centre for Biologics Evaluation and Research ("CBER"), the specialist biologics division of the FDA. Trinam® has already been given Orphan Drug Status in the USA and in Europe. Ark intends to submit a rolling Biologic Licence Application (BLA) for sale and marketing approval in the US in due course.

Dr David Eckland, Research and Development Director at Ark, commented: "This is the next important milestone in the regulatory progress of Trinam®. The problem of vascular access blocking in kidney dialysis patients has been identified as one of the key medical issues to be resolved in the US and we look forward to working closely with the FDA to expedite the development and review of Trinam®."

Dr Nigel Parker, Chief Executive Officer of Ark, added: "We are very pleased that Trinam® has been designated as a Fast Track Product. Trinam® targets a $750 million market where there is a significant unmet therapeutic need and this news potentially accelerates the development of this important product."

Trinam®

Trinam® is a combination of a vascular endothelial growth factor gene in an adenoviral vector (Ad-VEGF-D) and Ark's biodegradable local delivery collagen collar device (EG001). At the end of the access graft surgery procedure, the collar is fitted around the outside of the vein/graft join. The Ad-VEGF-D solution, which reduces the likelihood of blood clots and intimal hyperplasia, is then injected into the space between the wall of the collar and the blood vessel. This unique method of administration of the gene localises its delivery to the target tissue site, maximising efficacy, avoiding systemic distribution and thus minimising the potential for side effects.

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Ark Therapeutics Group plc