AnGes Submits Application for Marketing Approval to PMDA for HGF gene therapy for Critical Limb Ischemia
January 22 2018 - 10:11PM
AnGes, Inc., a biopharmaceutical company focused on developing
innovative gene-based medicines for serious diseases, announced
today the submission of an application for marketing approval to
the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for
HGF plasmid, an investigational gene therapy for the treatment of
critical limb ischemia (CLI), the most severe condition of
peripheral arterial disease.
The submission is based on the positive results
from the randomized, placebo-controlled phase 3 trial and
investigator-led clinical study conducted in Japan. AnGes
anticipates being granted conditional approval under the regulatory
scheme of “Approval with Conditions and Time Limit” for
regenerative medicines. The review process is expected to take
approximately one year. HGF plasmid has the potential to be one of
the first gene therapy products to be approved for a non-genetic
disease with chronic conditions.
AnGes grants to Mitsubishi Tanabe Pharma
Corporation the marketing rights to HGF plasmid for peripheral
arterial diseases including CLI in Japan and the US. Once approved,
Mitsubishi Tanabe will be responsible for the sales and marketing
of the product.
About Critical Limb Ischemia
(CLI)CLI is caused by worsened arterial blood flow in the
lower limb due to arteriosclerosis, for which risk factors include
diabetes, hypertension and smoking. The disease is estimated to
affect approximately 500,000 patients newly every year in the US.
CLI causes severe pain and/or ulcers leading to amputation when
there is no therapeutic option left, and thus quality of life in
patients deteriorates severely.
About HGF plasmidHGF plasmid is
a DNA plasmid that encodes human Hepatocyte Growth Factor (HGF)
gene, an angiogenic (growing new blood vessels) factor. It is
administered intramuscularly into the lower limb and is expected to
help grow new blood vessels leading to improved blood flow.
About
AnGesAnGes is a biopharmaceutical company focused on the
development and commercialization of gene-based medicines including
gene therapy and oligonucleotide medicines. In addition to HGF
plasmid, the company’s lead product under development, AnGes
develops NF-kB Decoy oligonucleotide for the treatment of
inflammatory diseases. The company is located in Tokyo and Osaka,
Japan and is listed on Mothers of Tokyo Stock Exchange, a market
for emerging companies.
Forward-Looking StatementThis
news release contains forward-looking statements. Any
forward-looking statements are based on the current expectations of
the company’s management and are subject to significant risks and
uncertainties.
Disclaimer: This is a translation of a news
release published in Japanese. In the event of any deviations
between the two language versions, the original document in
Japanese shall take precedence.
AnGes, Inc.Corporate CommunicationsTEL:
+81-3-5730-2641, FAX: +81-3-5730-2635http://www.anges-mg.com