AnGes Submits Application for Marketing Approval to PMDA for HGF gene therapy for Critical Limb Ischemia
TOKYO, Jan. 23, 2018 (GLOBE NEWSWIRE) -- 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 plasmid
HGF 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.
AnGes 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.
This 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.
TEL: +81-3-5730-2641, FAX: +81-3-5730-2635
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: AnGes MG, Inc. via Globenewswire
Följ NASDAQ OMX
Abonnera på våra pressmeddelanden.
Senaste pressmeddelandena från NASDAQ OMX
Luxembourg Announced as SNOMED International's Newest Member24.5.2018 15:16 | Pressmeddelande
London, United Kingdom, May 24, 2018 (GLOBE NEWSWIRE) -- SNOMED International and Agence eSanté Luxembourg are pleased to announce that Luxembourg has joined the organization as its thirty-second Member. Luxembourg, one of the leading nations in the area of information and communication technology, has set the development of eHealth technologies as a high priority. Agence eSanté, Luxembourg's national agency for the exchange and sharing of medical data, has set an overall mission to facilitate clinical information exchange both within Luxembourg and across other international actors. To work towards this reality, the agency has taken part in discussions about standardization across Europe, a contributing building block achieved with its membership in SNOMED International. With their membership, Agence eSanté has committed their support for the use of structured clinical terminology. When applied to the health sector, interoperability ensures that information systems, and through them h
SEMAFO Signs Underground Mining Services Contract with AUMS24.5.2018 14:00 | Pressmeddelande
MONTREAL, May 24, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) reports that it has signed a mining services contract with African Underground Mining Services ("AUMS") to provide turnkey mining services for Siou underground. AUMS is a well-known and reputable mining contractor with underground experience in Burkina Faso and across Africa. Under the mining services contract, AUMS will be responsible for supplying the mining fleet and a skilled labour force for Siou underground in addition to ensuring development, production and auxiliary services. SEMAFO will provide technical services including geology and engineering as well as leveraging the existing surface infrastructure at Mana. The mining services contract has a term of 70 months. The economic terms of the mining services contract are consistent with the economics presented in the Mana pre-feasibility study filed March 29, 2018 on SEDAR. Preparatory work has already commenced on Siou underground with full project deplo
Merus Announces First Patient Dosed in Phase 1 Clinical Trial of MCLA-158 in Patients with Solid Tumors24.5.2018 13:00 | Pressmeddelande
- IND Accepted in April by the U.S. FDA for MCLA-158 - UTRECHT, The Netherlands, May 24, 2018 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA-158 in patients with solid tumors with an initial focus on metastatic colorectal cancer. The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States. MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal grow
PRA Named International Clinical Research Company of the Year24.5.2018 10:00 | Pressmeddelande
RALEIGH, N.C., May 24, 2018 (GLOBE NEWSWIRE) -- PRA Health Sciences, Inc. (NASDAQ:PRAH) is pleased to announce it was recognized by PharmaTimes as the International Clinical Research Company of the Year. This is the fifth year in a row that PRA has received this award. "This award celebrates excellence in the clinical research industry and we are honored to once again be recognized by our peers," said Colin Shannon, President and Chief Executive Officer. "This award is possible thanks to the incredibly talented PRA team members we have working around the world who are deeply committed to their work in bringing new and life-saving therapies to the patients who need them." PRA also swept the Clinical Research Associate and Clinical Trial Administrator categories capturing a total of 11 awards. These awards follow PRA's recognition earlier this month in the PharmaTimes Americas competition where PRA also received 11 awards, including Company of the Year. The PharmaTimes, International Cli
Immunicum AB: Inbjudan till investerarträff24.5.2018 08:00 | Pressmeddelande
Pressmeddelande 24 maj 2018 Immunicum AB: Inbjudan till investerarträff Immunicum AB (publ; IMMU.ST) meddelade i dag att bolaget kommer att anordna en investerarträff i Kalmar den 13 juni kl. 18:00 CEST. Carlos de Sousa, Immunicums VD, kommer att hålla en presentation av det dagsaktuella läget, och han och övriga i ledningen kommer vara tillgängliga för att svara på frågor. Kalmar Datum: Onsdag 13 juni 2018 Tid: 18:00 - 20:00 CEST Plats: Kalmar Slott, Kungsgatan 1, 392 33 Kalmar För att delta på träffen, skicka ett mejl till firstname.lastname@example.org med ditt fullständiga namn. För ytterligare information kontakta: Carlos de Sousa, VD, Immunicum Telefon: +46 (0) 31 41 50 52 E-post: email@example.com Michaela Gertz, Finanschef, Immunicum Telefon: +46 (0) 31 41 50 52 E-post: firstname.lastname@example.org Media Relations Gretchen Schweitzer och Joanne Tudorica Trophic Communications Telefon: +49 172 861 8540 E-post: email@example.com Om Immunicum AB (publ) Immunicum etablerar ett unikt angreppssätt inom im
Immunicum AB: Invitation to Investor Event24.5.2018 08:00 | Pressmeddelande
Press Release 24 May 2018 Immunicum AB: Invitation to Investor Event Immunicum AB (publ; IMMU.ST) announced today that the Company will host an investor event in Kalmar on June 13 starting at 18:00 CEST. Carlos de Sousa, CEO of Immunicum, will give the current corporate presentation and he and other members of the Immunicum leadership team will be available for a question and answer session. Kalmar Date: Wednesday, June 13, 2018 Time: 18:00 - 20:00 CEST Location: Kalmar Slott, Kungsgatan 1, 392 33 Kalmar To register to attend the event, please send an email to firstname.lastname@example.org with your full name. For more information, please contact: Carlos de Sousa, CEO, Immunicum Telephone: +46 (0) 31 41 50 52 E-mail: email@example.com Michaela Gertz, CFO, Immunicum Telephone: +46 70 926 17 75 E-mail: firstname.lastname@example.org Media Relations Gretchen Schweitzer and Joanne Tudorica Trophic Communications Telephone: +49 172 861 8540 E-mail: email@example.com About Immunicum AB (publ) Immunicum is establis
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum