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
Mandalay Resources går ut med måldatum för publicering av resultatet för det fjärde kvartalet och hela 2017 samt konferenssamtal19.2.2018 03:42 | Pressmeddelande
TORONTO, 16 februari 2018 (GLOBE NEWSWIRE) -- Mandalay Resources Corporation ("Mandalay" eller "Bolaget") (TSX:MND) meddelade idag att resultaten från det fjärde kvartalet och hela 2017 kommer att släppas efter att marknaden stängt den 21 februari 2018. Detta efterföljs av ett konferenssamtal för investerare och analytiker med Mandalays President och Chief Executive Officer, Mark Sander, den 22 februari 2018 klockan 08:00 (Toronto-tid). Analytiker och investerare inbjuds att delta med följande uppringningsnummer: Deltagarnummer: (201) 689-8341 Deltagarnummer (avgiftsfritt): (877) 407-8289 Konferens-ID: 13676606 En repris av konferenssamtalet kommer att finnas tillgänglig fram till den 8 mars 2018 klockan 23:59 (Toronto-tid), vilken man kommer åt med följande uppringningsnummer: Encore avgiftsfritt uppringningsnummer: (877) 660-6853 Encore-ID: 13676606 För mer information: Mark Sander President och Chief Executive Officer Greg DiTomaso Director of Investor Relations Kontakt: +1.647.260.
Standard Lithium Announces Closing of $21.6 million Bought Deal Private Placement of Units16.2.2018 19:25 | Pressmeddelande
THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES. VANCOUVER, British Columbia, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Standard Lithium Ltd. ("Standard Lithium" or the "Company") (TSX-V:SLL) (OTCQX:STLHF) (FRA:S5L) announced today that it has closed its previously announced bought deal private placement of 10,312,821 units of the Company (the "Units"), at a price of $2.10 per Unit, for aggregate gross proceeds to the Company of $21,656,924, including the issuance and sale of the Underwriters' (as defined below) option (the "Offering"). Each Unit consists of one common share of the Company and one-half of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant is exercisable to acquire one common share of the Company (a "Warrant Share") until February 16, 2020 at an exercise price of $2.60 per Warrant Share, subject to adjus
Cisco Offers Cloud-Based Endpoint Security Solutions for Managed Security Service Providers16.2.2018 14:00 | Pressmeddelande
Cisco's comprehensive cloud-based security endpoint portfolio provides advanced malware protection, internet security, and enterprise mobility management SAN JOSE, Calif., Feb. 16, 2018 (GLOBE NEWSWIRE) -- Cisco today is helping address the challenges of Managed Security Service Providers (MSSP) and their customers by offering MSSPs comprehensive security, visibility, and control of customer endpoints without added hardware or complexity. The Cisco endpoint security portfolio includes three industry-leading solutions-Cisco AMP for Endpoints, Cisco Umbrella, and Meraki Systems Manager to offer protection against advanced malware and threats. Security teams know the endpoints in their environments are being targeted by advanced threats, but often lack the security talent, tools, and budget to address those challenges. As a result, organizations of all sizes are choosing to augment their in-house IT security with managed security services. Nearly half of SMBs and enterprises in the US1 ar
Aurora Solar Adds Heterojunction Cell Characterization to Decima Gemini Family16.2.2018 14:00 | Pressmeddelande
Aurora Solar Technologies Inc. / Aurora Solar Adds Heterojunction Cell Characterization to Decima Gemini Family . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. NORTH VANCOUVER, British Columbia, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Aurora Solar Technologies Inc. ("Aurora") ("Company") (TSX.V:ACU) (OTCBB:AACTF) (FSE:A82) is pleased to provide an update on the further development of its Decima Gemini(TM) infrared measurement technology for applications in the rapidly developing heterojunction (HJT) cell manufacturing market. HJT is an ultra high-efficiency solar cell design pioneered by Japan's Panasonic Corp., who is now also partnered with Tesla Inc. for solar products. According to Solar Media Ltd., HJT production capacity is expected to increase by 20 percent this year. To produce the electrical structure of a HJT cell, it is necessary to apply thin layers of amorphous silicon on both sides of a crystallin
Nasdaq Cited as a Leader in Governance, Risk, and Compliance Platforms by Independent Research Firm16.2.2018 13:35 | Pressmeddelande
NEW YORK, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq:NDAQ) was among the select companies that Forrester invited to participate in its 2018 Forrester Wave(TM) evaluation, Governance, Risk, And Compliance (GRC) Platforms, Q1 2018. In this evaluation, Nasdaq was cited as a Leader in Governance, Risk, and Compliance Platforms and received the maximum score of 5 for the evaluation criteria "Risk & Control Management", "Audit Management", "Dashboard and Reporting" and "Integration capabilities" for its BWise solutions. "We feel the strong scores we obtained in important functional areas provide assurance to our clients that they have selected a robust and future-proof software platform," said Tom Passon, Head of Product Innovation & Global Standards, Nasdaq BWise. "We are proud of this recognition that encourages us to further execute on our strategy to provide user-friendly, pre-configured best practice solutions that combine our innovative GRC software platform with leading expertis
Mandalay Resources Provides Target Release Date for Fourth Quarter and Full-Year 2017 Financial Results and Conference Call16.2.2018 13:30 | Pressmeddelande
TORONTO, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Mandalay Resources Corporation ("Mandalay" or "the Company") (TSX:MND) today announced that its fourth quarter and full-year 2017 financial results will be released after market close on February 21, 2018, followed by a conference call with Mark Sander, President and Chief Executive Officer of Mandalay, for investors and analysts on February 22, 2018 at 8:00 am (Toronto time). Analysts and interested investors are invited to participate using the following dial-in numbers: Participant Number: (201) 689-8341 Participant Number (Toll free): (877) 407-8289 Conference ID: 13676606 A replay of the conference call will be available until 11:59 pm (Toronto time), March 8, 2018 and can be accessed using the following dial-in number: Encore Toll Free Dial-in Number: (877) 660-6853 Encore ID: 13676606 For Further Information: Mark Sander President and Chief Executive Officer Greg DiTomaso Director of Investor Relations Contact: +1.647.260.1566 About Man
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum