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:5/23/2013)... , May 23, 2013  Haemonetics Corporation (NYSE: ... , CFO & EVP-Business Development, will present at The Deutsche ... Boston, MA on May 29, 2013 ... ) The public may access Mr. Lindop,s ... About Haemonetics Haemonetics (NYSE: HAE ...
(Date:5/23/2013)... , May 23, 2013 Hearing health affects a ... younger, and remain socially and professionally engaged, he should address ... overriding message that the Better Hearing Institute (BHI) ... National Men,s Health Week , which leads up to ... runs from June 10 through June 16. ...
(Date:5/23/2013)... 23, 2013  A recently published clinical study conducted ... Texas , demonstrates that 3D mammography (breast tomosynthesis) ... The study, "Implementation of Breast Tomosynthesis ... led by Stephen L. Rose , ... American Journal of Roentgenology (AJR). The AJR ...
Breaking Medicine Technology:Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 2Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 3Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 4First Large-Scale U.S. Study Validates the Benefits of 3D Mammography (Breast Tomosynthesis) Exams 2First Large-Scale U.S. Study Validates the Benefits of 3D Mammography (Breast Tomosynthesis) Exams 3
...  Internal Fixation Systems, Inc. (OTCQB: IFIX), ... value priced orthopedic and podiatric implants is pleased to report ... feature Internal Fixation Systems (IFS) as its feature cover ... its innovative approach to addressing the critical cost control ...
... 26, 2012 Marken announced today that it has opened ... new offices will provide the company with unique access to ... expand into new supply chain services. The two offices will ... and depot facilities and enable it unlimited 24/7 access to ...
Cached Medicine Technology:Internal Fixation Systems, Inc. Featured Cover Story in February Issue of MicroCap Review 2Marken Opens New Corporate Offices 2
(Date:5/24/2013)... 2013 Gift Card Network members ... in sustainable card material, are combining forces to ... as a sustainable gift card substrate. , The ... challenges and increase education and usage of these ... the reduction of carbon footprint and environmental impact ...
(Date:5/24/2013)... May 24, 2013 Let’s face it: very ... not uncommon for the majority of people to be uncomfortable ... due to a coffee addiction or simply genetics, yellowish or ... are so popular. , Herald Square Dental is ... effective whitening system: Venus White Max. , Teeth become ...
(Date:5/24/2013)... City, Utah (PRWEB) May 24, 2013 ... , with exciting new enhancements for instructors and students. ... stay more focused through personalize learning plan templates, targeted ... AnatomyOne release provides 500 new assessment questions, 5,000 searchable ... review notes. , AnatomyOne 2.0 is the ...
(Date:5/24/2013)... to the development of infantile myofibromatosis (IM)a disorder characterized ... tissuemay provide new therapeutic targets, according to researchers from ... findings, published in the American Journal of Human ... this debilitating disease, for which the only current treatment ... IM is an inheritied disorder that develops in infancy ...
(Date:5/24/2013)... Mike Stoler believes that there is much ... in New York. That’s why he hosts “Building ... TV. And that’s why he invited Robert Glazer, ... (ENTA)—the largest single specialty practice in the greater New ... audiology specialists and sub-specialists service communities throughout New York ...
Breaking Medicine News(10 mins):Health News:Making Gift Cards Greener- Competitors Combine Efforts to Educate and Empower Merchants 2Health News:Making Gift Cards Greener- Competitors Combine Efforts to Educate and Empower Merchants 3Health News:Herald Square Dental Introduces New In-office Whitening System: Venus White Max 2Health News:Amirsys AnatomyOne 2.0 Delivers Personalized Learning Plans 2Health News:Researchers identify first drug targets in childhood genetic tumor disorder 2Health News:Robert Glazer, Chief Executive Officer of ENT and Allergy Associates, LLP®, Talks About the Business of Succeeding in New York 2Health News:Robert Glazer, Chief Executive Officer of ENT and Allergy Associates, LLP®, Talks About the Business of Succeeding in New York 3Health News:Robert Glazer, Chief Executive Officer of ENT and Allergy Associates, LLP®, Talks About the Business of Succeeding in New York 4
... Distance to care not a factor, study finds, urging greater ... News) -- Living farther away from transplant centers doesn,t explain ... apt than whites to be placed on the kidney transplant ... team that analyzed data on end-stage renal (kidney) disease patients ...
... start-ups, without forcing doctors into ... ... Corporation,today announced the pre-release of Praxis Electronic Medical Records,Version 4, featuring ... tap into the knowledge of other clinicians,enabling rapid start- ups for ...
... Nov. 9 Innovation Management Group,Inc. (IMG) announced ... 1.50, a,low cost, full screen magnification software. Most ... individuals who have extreme visual,impairments or are legally ... hundred to,several thousand dollars. The Magnifier is the ...
... at Military Bases and for Download -, PHOENIX, ... members, their families and veterans will be available,beginning Nov. ... Fighting, America Supports You, TriWest Healthcare Alliance and,many other ... "For the Troops" at 4 p.m. on,Nov. 16 at ...
... Genome Sciences,Inc. (Nasdaq: HGSI ) announced today that ... be webcast and may be accessed at, http://www.hgsi.com ... of Human Genome Sciences, senior management team will present,an ... at 4:30 pm Eastern,Time. Investors interested in listening ...
... genes associated with the Alzheimer,s ... FRESNO, Calif., Nov. 9 Consuming grapes may ... presented,this week at the Society for Neuroscience conference in ... in grapes, which,includes resveratrol, quercetin, catechins and other phytonutrients, ...
Cached Medicine News:Health News:Blacks in Poor Areas Less Likely to Be On Kidney Transplant Lists 2Health News:Infor-Med, Inc. Announces New Praxis EMR Version 4 with The Praxis Knowledge Exchanger(R) 2Health News:IMG Announces an Affordable Full Screen Software Magnifier for Home and Business Users 2Health News:TriWest, Grammy-Nominated Artist and Partners Release 'For the Troops' CD in Appreciation of Military Members 2Health News:TriWest, Grammy-Nominated Artist and Partners Release 'For the Troops' CD in Appreciation of Military Members 3Health News:Eating Grapes May Protect Against Alzheimer's Disease 2
Used for vascular access. Supplied sterile in peel-open packages. Intended for one-time use....
Used for arterial and venous punctures. The tapered hub design of the catheter facilitates wire guide introduction. Supplied sterile in peel-open packages. Intended for one-time use....
Used for placement of .035 inch (0.89 mm) or .038 inch (0.97 mm) diameter wire guides into the vascular system when a small 21 gage needle stick is desired....
Used to introduce balloon, closed and non-tapered end catheters or other devices for intervention....
Medicine Products: