Nuvelo: Alfimeprase study yields positive results for central venous catheter occlusion

By E. Janene Geiss

Philadelphia, July 6 - Nuvelo, Inc. said Thursday that phase 2 clinical trial results demonstrated that alfimeprase can quickly restore function to occluded central venous access devices (CVADs).

This phase 2 randomized, double-blind, controlled, dose-ranging study compared the safety and activity of three fixed doses of alfimeprase (0.3 mg, 1 mg and 3 mg) against the approved dose of CathfloActivase (alteplase), according to a company news release.

In the study, 55 patients were treated to re-establish patency to their occluded CVADs.

Catheter patency was assessed at five, 15, 30 and 120 minutes after drug was given, officials said.

If patency was not achieved at 120 minutes after the first dose of either alfimeprase or CathfloActivase, patients received a second dose.

Adverse events, including bleeding events, were assessed for a 30-day period after exposure to study drug.

The results demonstrated that at the highest dose of 3 mg of alfimeprase produced cumulative patency rates of 40% at five minutes, 50% at 15 minutes and 60% at 30 and 120 minutes after the first dose, as well as 80% at 120 minutes after the second dose, officials said.

By comparison, CathfloActivase produced patency rates of 0% at five and 15 minutes, 23% at 30 minutes and 46% at 120 minutes after the first dose, as well as 62% at 120 minutes after the second dose.

No major hemorrhagic events were reported in any treated patients, officials said.

"Restoration of CVAD function within minutes is important because it may facilitate timely delivery of prescribed therapies or enable early identification of CVAD obstructions that require prompt catheter replacement," Steven R. Deitcher, vice president of medical sciences for Nuvelo and former principal investigator for the trial, said in the release.

Results of the study were published in the July 1 issue of the Journal of Clinical Oncology, officials said.

The company said it has begun two overlapping, multinational phase 3 trials evaluating the 3 mg dose of alfimeprase in catheter occlusion.

Data from the first of these trials is expected in the second half of this year, officials said.

Alfimeprase is an enzyme produced by recombinant DNA technology that rapidly dissolves blood clots through a unique mechanism of action - it directly degrades fibrin, a protein that provides the scaffolding for blood clots.

Nuvelo said it plans to begin a phase 2 trial of alfimeprase for the treatment of ischemic stroke in the second half of 2006 and an additional phase 2 trial of alfimeprase for the treatment of deep venous thrombosis in 2007.

In January, a collaboration was formed between Nuvelo and Bayer HealthCare for the development and commercialization of alfimeprase.

Under the agreement, Bayer will commercialize alfimeprase in all territories outside the United States and will pay Nuvelo tiered royalties ranging from 15% to 37.5%. Nuvelo retains commercialization rights in the United States and is eligible to receive up to $385 million in milestone payments from Bayer, officials said.

Bayer is responsible for 40% of the costs for global development programs, and Nuvelo said it is responsible for 60% of the costs and will remain the lead for the design and conduct of the global development programs.

Nuvelo is a San Carlos, Calif., biopharmaceutical company focused on acute cardiovascular and cancer therapy.

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