Navigation Links
Vical Licensee AnGes MG Announces Positive Results of Phase 3,Angiogenesis Trial in Japan

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, th
'"/>




Page: 1 2 3 4 5

Related medicine technology :

1. Vical Interim Clinical Results Demonstrate Safety and Tolerability of Inovio Biomedicals Electroporation DNA Delivery Technology
2. Vicals Vaxfectin Adjuvant With Needle-free Delivery Enhances DNA Vaccine Performance; Yields Antibody Responses Comparable to Electroporation Without Tolerability Issues
3. Vicals Vaxfectin Adjuvant Achieves Dose-Sparing Effect With Seasonal Influenza Vaccine
4. Geron Corp. Licensee TA Sciences Announces Landmark 7/07/07 Teleconference to Answer Questions About TA-65, Their Telomerase Activator With Proven Age Management Benefits
5. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
6. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
8. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
9. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
10. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
11. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
Post Your Comments:
(Date:7/30/2014)... YORK and KISSING, Germany ... and distributor of a single use and computer-assisted ("robotic") ... (Homi) Shamir , a worldwide recognized medical device executive, ... Mr. Shamir is a highly respected global ... recent assignment he served as President and Chief Executive ...
(Date:7/30/2014)... and PARIS , July 30, ... ) and Sanofi (EURONEXT: SAN and NYSE: ... ODYSSEY trials of alirocumab in people with hypercholesterolemia met ... from baseline in low-density lipoprotein cholesterol (LDL-C) at 24 ... an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin ...
(Date:7/30/2014)... -- DigiPath, Inc. (OTCBB and OTCQB: DIGP), a digital pathology ... and education markets, announced today that has been no ... disclosed or, to its knowledge, any other reason to ... "We have noticed unusual price and volume increases for ... Steve Barbee , CEO of DigiPath. "While we ...
Breaking Medicine Technology:invendo medical Appoints Nachum (Homi) Shamir To The Company's Board Of Directors 2invendo medical Appoints Nachum (Homi) Shamir To The Company's Board Of Directors 3Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 2Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 3Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 4Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 5Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 6Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 7Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 8DigiPath No New Corporate Developments 2
... 2011 Gamma Pharmaceuticals, Inc. (NASDAQ: GMPM.PK), a marketing ... through wholesalers and direct to retailers, both in the ... a sale and revenue collection cycle with a major ... products to a Northeast distribution center for delivery to ...
... Md., June 27, 2011 Glycotex, Inc., a ... has submitted the final results of the two ... product candidate, GLYC-101 gel, to the clinicaltrials.gov database. ... investigational GLYC-101 on wound closure in patients undergoing ...
Cached Medicine Technology:Gamma Pharmaceuticals, Inc. Completes Sale and Books Revenue with National Pharmacy Chain 2Gamma Pharmaceuticals, Inc. Completes Sale and Books Revenue with National Pharmacy Chain 3Glycotex, Inc. Releases Final Phase II Clinical Trials Results in the Clinicaltrials.gov Database and Announces the Results of the Mechanism of Action Study for its Product Candidate GLYC-101 2Glycotex, Inc. Releases Final Phase II Clinical Trials Results in the Clinicaltrials.gov Database and Announces the Results of the Mechanism of Action Study for its Product Candidate GLYC-101 3Glycotex, Inc. Releases Final Phase II Clinical Trials Results in the Clinicaltrials.gov Database and Announces the Results of the Mechanism of Action Study for its Product Candidate GLYC-101 4
(Date:7/31/2014)... WA (PRWEB) July 31, 2014 ... family practice provider? Community Health Center of Snohomish ... “ Pediatricians vs. Family Doctors ”. Many adults ... are available to them. Community Health Center hopes ... similarities and differences between the two. , ...
(Date:7/31/2014)... The shale gas development that has vaulted ... U.S. natural gas production has raised concerns that local ... similar to previous resource extraction experiences in Pennsylvania’s history. ... & Jefferson College’s (W&J) Center for Energy Policy & ... that the gas boom in Pennsylvania is still underway, ...
(Date:7/31/2014)... OR (PRWEB) July 31, 2014 Sales in ... from 2013 to 2014, according to radio talk show host ... been experiencing rapid growth since 1990. The US economy in ... Kleyne Hour Power of Water radio show, reported this information ... Live Foods, a worldwide manufacturer of organic and natural food ...
(Date:7/31/2014)... 2014 According to new research ... Mycoprotein), by Type (Tofu, Tofu-Based Product, Tempeh, TVP, ... Global Trends & Forecasts to 2019", defines and ... analysis and forecasting of the market value of ... report also identifies the driving and restraining factors ...
(Date:7/31/2014)... 31, 2014 Care Communications, Inc., (CARE) ... firm, has received the Elite Award for “Recruitment, Selection ... one of twelve elite awards presented as part of ... Work For” 2014 awards competition. This marks the ... Award in the competition. CARE has also been chosen ...
Breaking Medicine News(10 mins):Health News:Community Health Center of Snohomish County Reveals the Differences Between Pediatricians and Family Practice Providers 2Health News:Pennsylvania’s Shale Gas: Examining the Boom and Bust Cycle 2Health News:Pennsylvania’s Shale Gas: Examining the Boom and Bust Cycle 3Health News:Organic Food Industry Grew 12% in 2013-2014 Reports Sharon Kleyne Hour Power of Water Host 2Health News:Organic Food Industry Grew 12% in 2013-2014 Reports Sharon Kleyne Hour Power of Water Host 3Health News:Meat Substitutes Market Worth $4,622.4 Million by 2019 - New Report by MarketsandMarkets 2Health News:Meat Substitutes Market Worth $4,622.4 Million by 2019 - New Report by MarketsandMarkets 3Health News:Care Communications, Inc. Named an Elite Award Winner Among Top Chicago Employers 2
... , , HOFFMAN ESTATES, Ill., July 16 ... of America,s top medical institutions in the annual America,s Best Hospitals list ... magazine. St. Alexius Medical Center was ranked among the top 50 ... , , (Photo: http://www.newscom.com/cgi-bin/prnh/20090716/CG47487 ...
... , , CARLSBAD, Calif., July 16 ... and microbial nucleic acid purification, announces the launch of an innovative ... genomic DNA from food cultured microorganisms. , , ... other commercial food kits with its easy-to-use protocol that allows for ...
... , , PALO ALTO, Calif., ... has been elected chairman of the company,s Board of Directors. , ... the biotechnology industry, and as the former chairman of Connetics Corporation ... leadership and success to TOPICA, as well as an exceptional knowledge ...
... , CHICAGO, July 16 Lexington Health ... services for those needing sub-acute medical and rehabilitative services as ... directors has named Dale Zaletel as the company,s new chief ... held the position of Chief Operating Officer since joining Lexington ...
... , Gamers Engage Memory, Attention, Processing Skills ... /PRNewswire-USNewswire/ -- The MS Technology Collaborative has created a ... brain power. The Collaborative, an alliance of Bayer HealthCare Pharmaceuticals, Microsoft, ... a free suite of online cognitive games for the MS community. ...
... , , , ... one of the nation,s leading domestic manufacturers of prescription foot ... awarded the prestigious Employer of the Year award, which is ... recognizes private sector employers that provide outstanding employment opportunities and ...
Cached Medicine News:Health News:St. Alexius Medical Center Named to America's Best Hospitals Rankings 2Health News:MO BIO Laboratories, Inc. Launches PowerFood(TM) Microbial DNA Isolation Kit 2Health News:TOPICA Elects G. Kirk Raab as Chairman of the Board 2Health News:Lexington Health Care Names New Chief Executive Officer 2Health News:Technology Collaborative Launches Online Game to Exercise Brain Power of People with Multiple Sclerosis 2Health News:Technology Collaborative Launches Online Game to Exercise Brain Power of People with Multiple Sclerosis 3Health News:Technology Collaborative Launches Online Game to Exercise Brain Power of People with Multiple Sclerosis 4Health News:PAL Health Technologies Wins State-Level Prestigious 'Employer of the Year' Award 2
... TruFit® CB Plugs use OBIs ... a scaffold for tissue repair that ... stable. A patented composite of ... the PolyGraft® material can be fabricated ...
The TruGraft BGS Granules are to be used in bone void filling of surgically or traumatically created osseous defects....
... the first to manufacture a diode pumped ... to announce their newest addition, the VITRA. ... the problem that many doctors face when ... No larger than a shoe box, this ...
... Resistant Tips offer a safe alternative to ... designed for applications such as PCR(a), pipetting ... ART Tips are excellent for tissue culture, ... ART Tips prevent aerosol contaminants and liquids ...
Medicine Products: