Date: 2011-11-15
Type of information: Initiation of preclinical development
phase: 2
Announcement: completion of patient enrolment
Company: ProFibrix (The Netherlands)
Product: Fibrocaps™
Action
mechanism: Fibrocaps™ is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery.
Disease:
Therapeutic area: Hemostasis
Country: USA, Europe
Trial
details: These Phase II clinical trials of Fibrocaps (FC-002 US and FC-002 NL) build on the success of ProFibrix’s first Phase II study at a number of centers in the Netherlands, which demonstrated a compelling safety and efficacy profile for Fibrocaps. The current Phase II trials are prospective, randomized, single-blind, controlled studies. The U.S. study endpoint of the study is the mean time to hemostasis (TTH) of Fibrocaps versus control. A total of 124 patients have been randomized across three different surgical indications: peripheral vascular surgery, spinal surgery, and liver resection was conducted at 11 sites and the Dutch study was conducted at 5 sites, which included major academic and leading private medical centers in the U.S. and the Netherlands. Apart from measuring overall safety, the primary efficacy surgery. The study has a 28-day follow-up and results are expected to be reported before the end of 2011.
The Phase II clinical trial of Fibrocaps (FC-002 NL) was a prospective, randomized (2:1), single-blind, controlled study in 56 subjects undergoing liver resection surgery. The Dutch study was conducted at 5 sites, which included major medical centers in the Netherlands. Fibrocaps was considered to have a very good safety profile, with no adverse events attributed to Fibrocaps, which is consistent with the previously conducted Phase II study. The primary efficacy endpoint of the study was an intent-to-treat analysis of the mean TTH of Fibrocaps versus active control. The TTH means were 2.2 min for Fibrocaps (n=39) and 4.4 min for control (n=17) (p=0.004).
Latest
news: * On November 15, 2011, ProFibrix has announced that its multicenter Phase II clinical trial with Fibrocaps in liver resection surgery resulted in a highly statistically significant 50% reduction in mean time to hemostasis (TTH) compared to active control. A total of 56 patients were enrolled in the company’s Dutch prospective, randomized, controlled, multi-center Phase II study with lead product Fibrocaps for mild to moderate surgical bleeding. The study results show that Fibrocaps has a very good safety profile along with rapid hemostatic activity that succeeds in significantly reducing mean time to hemostasis, the primary end point of the Phase II trial. The company remains on track to initiate a pivotal Phase III trial in H1 2012, and target a BLA filing in 2013 and expects in the coming months to report on the results of the Phase II trial iy is running in parallel in the U.S.
* On September 15, 2011, Profibrix has announced that it has completed patient enrollment in its two (U.S. and Dutch) prospective, randomized, controlled, multi-center Phase II studies with lead product Fibrocaps in surgical hemostasis. The company looks forward to reporting on the outcome of the trials before the end of 2011, and initiate a pivotal Phase III trial in H1 2012, which puts us on track for a BLA filing in 2013.
