Navigation Links
Vical Signs Binding Letter of Intent for Sales and Marketing of Allovectin-7(R) in Turkey
Date:12/3/2008

peutic as a single agent for patients with Stage III or IV metastatic melanoma. Based on advice from clinical experts and detailed guidance received from the U.S. Food and Drug Administration (FDA) in an End-of-Phase 2 meeting, Vical successfully completed a Special Protocol Assessment (SPA) with the FDA for a Phase 3 trial (the Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma, or AIMM trial) for certain patients with Stage III or Stage IV metastatic melanoma. The SPA agreement specifies that the trial design and planned analyses address the study's objectives and the resulting study data could provide the primary basis to support a product license application.

Allovectin-7(R) has been granted orphan drug designation for the treatment of invasive and metastatic melanoma by the FDA's Office of Orphan Products Development. Orphan drug designation provides U.S. marketing exclusivity for seven years if marketing approval is received from the FDA, in addition to certain tax benefits for qualifying expenses.

About the AIMM Trial

Vical is conducting a Phase 3 pivotal trial of the company's Allovectin-7(R) cancer immunotherapeutic as first-line therapy in chemotherapy-naive patients with Stage III or IV metastatic melanoma. The AIMM trial is being conducted in accordance with the SPA agreement at more than 60 clinical sites, and is currently enrolling patients in the United States, Canada and Europe. AnGes MG, Inc., is funding the clinical trial under a collaborative agreement with Vical.

The AIMM trial calls for enrollment of approximately 375 patients with Stage III or IV metastatic melanoma. Patients may have been previously treated with surgery, adjuvant therapy, and/or biotherapy, but cannot have been previously treated with cytotoxic chemotherapy. The patients will be randomized on a 2:1 basis: approximately 250 patients will be treated with Allovectin-7(R) and approximately 125
'/>"/>

SOURCE Vical Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Vical Receives Milestone Payment from Merck & Co., Inc. Triggered by Planned Initiation of Investigational Cancer DNA Vaccine Trial
2. Vical Completes Enrollment and Reports Positive Interim Data in CMV Vaccine Phase 2 Trial
3. U.S. Navy and U.S. Army to Develop Dengue DNA Vaccine Formulated With Vicals Vaxfectin(R) Adjuvant
4. Vical Expands Applications of Vaxfectin(R) Adjuvant for Infectious Disease and Cancer Vaccines; 80% to 100% of High-Dose Responders in H5N1 Clinical Trials Still Responding at 6 Months
5. First Published Study of New HPV Test for Developing Countries Shows High Accuracy in Predicting Cervical Disease
6. Karolinska Institutet to Test Vicals Vaxfectin(R) Adjuvant With Preventive Vaccine against HIV Under Sponsorship of Swedish Institute for Infectious Disease Control
7. Karolinska Institute to Test Vicals Vaxfectin(R) Adjuvant with Preventive Vaccine against HIV Under Sponsorship of Swedish Institute for Infectious Disease Control
8. Vical Announces Breakthrough for Pandemic Influenza DNA Vaccines With Preliminary Human Data
9. Vical Advances RapidResponse(TM) DNA Vaccine Platform Under $6 Million Grant from NIH
10. Vical Receives $6.3 Million Payment for Continued Funding of Allovectin-7(R) Phase 3 Trial
11. Ending Cervical Cancer Featured at Summit; QIAGEN CEO Issues a Call to Global Women Leaders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... Research and Markets ... the "Investigation Report on China,s Quetiapine Market, ... Developed by AstraZeneca plc, quetiapine (under the trade ... the treatment of schizophrenia. Approved by CFDA to ... the Catalogue of Drugs for the Basic National ...
(Date:8/28/2015)... 2015 The scientific team of a ... of the leading academics in the field of aging Prof. ... in life extension for model animals - 10 fold for ... and age-related diseases, primarily, around the stability and stress resistance ... published as "Stability analysis of a model gene network links ...
(Date:8/28/2015)... FARUM, Denmark and ATLANTA ... July 31, 2015 the US Food and Drug Administration (FDA) ... Major Depressive Disorder in adult patients who have failed to ... episode. TMS is a non-invasive technique for stimulating neural tissue ... from Major Depressive Disorder. The procedure has been proven safe ...
Breaking Medicine Technology:China Quetiapine Market Investigation Report 2010-2019 2Gero: Physics Meets Biology to Help Defeat Aging 2Gero: Physics Meets Biology to Help Defeat Aging 3Therapy System for Treating Major Depressive Disorder Receives FDA Clearance 2Therapy System for Treating Major Depressive Disorder Receives FDA Clearance 3
... ZeaVision, LLC announced two internal promotions as the ... its leading EyePromise® nutraceutical products featuring ... to President effective immediately from his previous role of ... appointment to the ZeaVision Executive Board. Founder, ...
... Sept. 1 In recognition of September,s designation as ... Pain Physicians (ASIPP) today announced that it is planning ... life for the approximately 75 million Americans suffering from ... this outreach, ASIPP has developed a consumer section on ...
Cached Medicine Technology:Nutraceutical Leader Announces Internal Promotions of Key Personnel 2American Society of Interventional Pain Physicians (ASIPP) Promotes Patient Education and Outreach Initiatives During National Pain Awareness Month 2
(Date:8/30/2015)... ... 30, 2015 , ... Scientists in France say asbestos exposure may put workers ... Surviving Mesothelioma has just posted an article on the new research. Click here ... cancer incidence among 2,024 French asbestos plant workers from 1978 to 2009. In addition ...
(Date:8/30/2015)... Raton, Fl (PRWEB) , ... August 30, 2015 ... ... that Kathleen Kall has been promoted from Administrative assistant to Executive Assistant to ... you’ll interact with a proven professional, focused on your goals. Kathleen graduated ...
(Date:8/29/2015)... ... August 29, 2015 , ... On Saturday, September 19, 2015, Diane Blackburn-Zambetti, ... (Meso Foundation) will present an educational program titled “Asbestos and Your Health.” , ... 9:30 PM (doors open at 6:45pm) at Calvary United Methodist Church, 16 E Park ...
(Date:8/29/2015)... ... August 29, 2015 , ... Brands like Toppik , ... standard shipping costs. , “Before, a threshold of $49.00 was required to qualify for ... items qualify for free standard shipping for customers regardless of the item’s selling price.” ...
(Date:8/29/2015)... ... August 29, 2015 , ... The popular television program VOICES IN AMERICA, ... that it will be devoting an entire short segment to the subject of diabetes. ... the globe on a daily basis, but recent advancements in medical science may prove ...
Breaking Medicine News(10 mins):Health News:Researchers Say Mesothelioma Not the Only Cancer Linked with Asbestos Exposure, According to Surviving Mesothelioma 2Health News:NPI Appoints New Executive Assistant To CEO 2Health News:Mesothelioma Applied Research Foundation to Hold Educational Class About Asbestos and Mesothelioma Prevention 2Health News:TheBeautyPlace.com Discounts Shipping on Select Brands 2
... at the University of Illinois at Chicago, in collaboration with ... precisely how the antibiotic linezolid inhibits bacterial growth. ... first new antibiotic to enter the marketplace in 30 years ... of the cell. But exactly where the binding occurred and ...
... Andhra Pradesh Chief Minister Y.S. Rajasekhara Reddy, who is ... University to set up an offshore campus in Hyderabad, ... ,The chief minister made the request after the signing ... and Satyam Computers' EMRI (Emergency Management and Research Institute) ...
... say they have developed a technique to attack and ... as nausea or hair loss. ,They ... attack cancer cells, but leave healthy tissue unaffected. ... with anti-cancer antibodies so they zero in on their ...
... struck Salisbury, suburb north of the Adelaide capital of the ... kid , sliding down in a popular playground, came into ... is not clear what happened to the kid, but a ... gone wrong. ,Health authorities described the chemical as ...
... People with HIV who drop out of care do not ... treatment, said Baylor College of Medicine and Veterans Affairs ... of Clinical Infectious Diseases and available on line. ... (the human immunodeficiency virus that causes AIDS) is keeping people ...
... artificial plastic blood, which they claim could act as a ... in war zones. ,The new artificial blood ... atom at their core, like haemoglobin, that can carry oxygen ... looking for extra funding to develop a final prototype that ...
Cached Medicine News:Health News:Researchers Discover How Antibiotic Inhibits Bacterial Growth 2Health News:Reddy Asks Stanford University to Open Hyderabad Campus 2Health News:New Cancer Therapy That can Be Less Painful 2Health News:Children Using Slide in Playground Treated for Exposure to Poisoning 2Health News:HIV Survival Improves If Patients Stay in Care 2
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: