Vical Licensee AnGes MG Announces Positive Results of Phase 3 Angiogenesis Trial in Japan
Monday June 18, 6:30 am ET
SAN DIEGO, June 18 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL - News) today announced that the company's licensee, AnGes MG, Inc. reported positive results following interim analysis of data from the first 41 subjects to complete a Phase 3 trial of an angiogenesis product candidate using Vical's DNA delivery technology. Based on the findings that the primary efficacy endpoint in the trial had been achieved with statistical significance and that there were no major safety concerns related to treatment, an Independent Data Monitoring Committee (IDMC) recommended stopping the trial early to prevent potential ethical issues against the placebo group subjects. AnGes is ending the trial and preparing to file an application for Japanese marketing approval.
"The successful Phase 3 results from our Japanese licensee position the AnGes product candidate to be the first approved for human use based on our DNA delivery technology and provide proof of concept for DNA delivery in the treatment of disease," said Vijay B. Samant, President and Chief Executive Officer of Vical. "This novel approach has the potential to address an important, unserved medical need in a significant commercial market. We look forward to further updates from AnGes as they advance through the regulatory approval process."
The treatment uses Vical technology to deliver a gene encoding Hepatocyte Growth Factor (HGF), a human protein that causes angiogenesis (growth of blood vessels) in areas of ischemia (restricted blood flow). In the trial, 40 subjects with critical limb ischemia (advanced peripheral arterial disease) were evaluated for efficacy. The primary endpoints, improvement of rest pain ((VAS (Visual Analog Scale)) or ischemic ulcer size, at 12 weeks post dosing, showed 30.8% improvement in the placebo group and 70.4% improvement in the treatment group, a statistically significant difference (p=0.014).
The following English translation of the original Japanese news release was provided by AnGes.
Announcement of Results of Phase III Clinical Trials
of HGF Gene Therapy in Japan
AnGes conducted an interim analysis of the PIII data using HGF Gene (AMG 0001) for Critical Limb Ischemia (CLI) in Japan, and is pleased to announce that remarkable improvement was observed in the AMG0001 group compared with the Placebo group.
Yesterday, an IDMC (Independent Data Monitoring Committee) was held, and now that the efficacy of AMG0001 is confirmed, the committee recommended to stop this trial in order to prevent potential ethical issues against the placebo group subjects. AnGes has accepted this advice today and decided to stop this trial. From now on, AnGes will closely communicate with governmental agencies and prepare for NDA filing.
Outline of Study Results
This trial is a randomized, placebo-controlled, double blind study for CLI subjects using AMG 0001.
In this efficacy evaluation, 40 subjects with CLI were evaluated. 27 subjects received AMG0001, and were compared with 13 placebo subjects. (The AMG0001 group received 8mg (4mg x 2) of AMG0001.)
The primary endpoints, which is, improvement of rest pain ((VAS (Visual Analog Scale)) or ischemic ulcer size, at 12 weeks post dosing, showed 30.8% improvement in Placebo group and 70.4% improvement in AMG0001 group and verified statistically significant difference (p=0.014)
As for safety, 41 subjects (AMG0001: 28 subjects, Placebo: 13 subjects) were evaluated.
Adverse drug reaction were equally distributed between AMG0001 group and placebo group.
There were 8 SAEs in 6 subjects in the AMG0001 group (peripheral ischemia, cerebella infarction, post procedural hematoma, prostate cancer, bladder perforation, acute renal failure, peritonitis, bacterial pneumonia). However, causality due to AMG0001 was estimated none or low. In Placebo group, there were 4 SAEs in 3 subjects (2 embolism, toe gangrene, pain in thigh).
All SAEs out of all studies using AMG0001 were evaluated by the DSMB (Data Safety Monitoring Board) and it was concluded that, as of today, there is no major safety concern related to AMG0001.
While significant improvement was confirmed based on the efficacy evaluation, as AMG0001 is a highly novel therapeutic, AnGes will continue development by carefully following the safety... |
