HGF Gene Therapy Product Collategene AnGes Inc. initiated Phase 2b study in the U.S. in patients with lower limb ischemic ulcers
- Category: DNA RNA and Cells
- Published on Tuesday, 04 February 2020 11:17
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February 4, 2020 I AnGes, Inc. (Head Office: Ibaraki City, Osaka; President and CEO: Ei Yamada) announced that the first patient has been enrolled in the clinical study in the U.S. evaluating the HGF gene therapy product beperminogene perplasmid in patients with arteriosclerosis obliterans with lower limb ischemic ulcers.
Overview of phase 2b clinical study in US:
- To assess the efficacy on foot ulcer healing in patients who have ischemic ulcers of the lower extremity in a small-scale clinical study;
- Approximately 60 subjects to be enrolled in the study;
- Total of 12 months of study participation including study treatment.
The progress of this study will be disclosed in a timely manner.
Collategene intramuscular injection 4 mg received conditional approval in Japan on March 26, 2019 for the improvement of ulcers in patients with chronic arterial occlusive diseases (arteriosclerosis obliterans and Buerger’s disease), and Mitsubishi Tanabe Pharma Corporation began launch Collategene from September 10, 2019. In addition, Anges, Inc. is conducting the phase 3 study targeted patients with rest pain to extend indication of Collategene from October 7, 2019.
The impact this will have on the full-year consolidated results for this fiscal year is currently being examined.