Navigation Links
Vical Promotes Melanoma Awareness Month With Allovectin-7(R) Video Report
Date:4/23/2008

uating Allovectin-7(R) immunotherapeutic 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 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.

Patients featured in the video report were selected from complete responders in earlier trials, and do not represent the majority. In the Phase 2 study, the overall response rate was 11.8%, including 11 partial responders and 4 complete responders from the 127 patients treated. The drug-related side effects in the Phase 2 study were predominantly mild and temporary, including pain and inflammation at the injection site and flu-like symptoms such as fatigue, fever, muscle and joint pain, and headache.

About the AIMM Trial

In early 2007, Vical initiated 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 M
'/>"/>

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

Page: 1 2 3 4 5

Related medicine technology :

1. Vical Reports Second Quarter 2007 Financial Results, Allowance of Pandemic Influenza IND and Other Advances in Product Development Programs
2. Multiple NIH Phase 2 HIV Vaccine Trials Using Vicals Technology Produce Encouraging Results
3. Vical Begins Phase 1 Trial of DNA Vaccine Against H5N1 Pandemic Influenza
4. Spine Institute of Louisiana Offers Cervical Spine Motion Preservation as an Alternative to Fusion Surgery
5. Vical Licensee Sanofi-aventis Initiates Phase 3 Trial to Reduce Amputations
6. The First Annual Cervical Cancer/HPV Conference Tackles Controversial Vaccine Issues and Encourages Advocacy
7. Vical Demonstrates Dose-sparing of Protein-based H5N1 Influenza Vaccine With Vaxfectin(TM) Adjuvant
8. New Study Shows Listeria Vaccine for Cervical Cancer Found Safe
9. Interim Safety Data Favorable for Vicals Phase 2 Trial of DNA Vaccine Against CMV
10. Vical Receives Payment from AnGes MG for Allovectin-7(R) Phase 3 Pivotal Trial
11. Nventa Evaluation Complete for First Three Cohorts in HspE7 Phase 1 Cervical Dysplasia Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/22/2014)... , Aug. 22, 2014  As the Medical ... sector, many leaders in this area are exploring methods ... The Medical Affairs Consortium at Best Practices, LLC ... for sharing insights about the key challenges they face. ... sharing solutions through three virtual roundtable discussions where leaders ...
(Date:8/22/2014)... 22, 2014 MC Medical, a subsidiary of Mitsubishi ... Columbus, OH medical device company, have formally ... and robotic visualization system in Japan . ... in Japan in the latter half ... an extensive product portfolio in endoscopic surgery market in ...
(Date:8/22/2014)... ., Aug. 22, 2014  Research presented at the ... therapy being developed by Hera Therapeutics Inc. combats three types ... of all cervical cancer. When tested in several ... HPV-18 and HPV-11 cells, according to Louise T. Chow ... the findings at the Seattle conference. ...
Breaking Medicine Technology:Best Practices' Medical Affairs Consortium Survey Has Achieved Strong Participation 2MC Medical agrees to be the exclusive distributor of FloShield products in Japan 2Study shows Hera Therapeutics experimental compound shuts down human papillomavirus that causes most cervical cancer 2
(Date:8/23/2014)... 23, 2014 Teen drug and alcohol ... no different in Wilmington, NC. Substance abuse can happen ... victim to drug and alcohol dependency in higher numbers ... to overcome substance abuse, but don’t know where to ... facility can be a challenge because most treatment options ...
(Date:8/23/2014)... Summer vacation is almost over and before we know it ... for school supplies and a new wardrobe might take precedence ... to also spend some time brushing up on bed bug ... in heavily populated places,” said Randy Rupert, Bed Bug Team ... settings for bed bugs to take up residence.” , An ...
(Date:8/22/2014)... IT manager of Top10BestSEOHosting.com is a web professional who ... recently announced that GoDaddy ( http://www.top10bestseohosting.com/go/GoDaddy.com/ ) is one ... is a popular supplier of cheap web hosting, and ... affordable rates. It offers three Linux shared hosting plans. ... the length of the contract. The longest contract length ...
(Date:8/22/2014)... Lynchburg, Va. (PRWEB) August 22, 2014 ... Center for Medical and Health Sciences , hosting ... the area’s top influencers in government and public welfare. ... University College of Osteopathic Medicine (LUCOM) joined Liberty ... building and the launch of the new medical school. ...
(Date:8/22/2014)... City, UT (PRWEB) August 22, 2014 ... published a new guide on Account-Based Health Plans. , ... plans (ABHPs) as a strategy to lower the cost ... different types of medical spending accounts, however, can be ... comparison chart to learn the four main types of ...
Breaking Medicine News(10 mins):Health News:Troubled Teens Wilmington Helpline Guides Adolescents to the Path of Recovery 2Health News:Expert Advice for a Bed Bug-Free School Year 2Health News:Liberty University Dedicates Its New Center for Medical and Health Sciences 2Health News:Liberty University Dedicates Its New Center for Medical and Health Sciences 3Health News:Liberty University Dedicates Its New Center for Medical and Health Sciences 4
... papillomavirus (HPV) could upset promising outcomes associated with In ... growth of warts, spread by the environment or by ... York Hospital-Cornell Medical Center discovered that women who tested ... conception through the IVF method, as compared to those ...
... United Kingdom is being nudged by a Swiss organization to ... that it can be considered for patients// suffering chronic mental ... Ludwig Minelli at the helm, is petitioning the Swiss Supreme ... "The question for politicians in Britain today is why do ...
... to high pollution levels can increase people’s susceptibility to stroke.// ... that the risk of stroke from pollution can more than ... heart problems are associated with the average daily amount of ... ,The findings of the study are published in Occupational ...
... study revealed that kids learning music acquire better memories, ... This study was conducted by// Laurel Trainor, professor of ... Ontario and her team. ,The study followed ... a music test after attending music classes for one ...
... entire world is a stage, and we are mere actors, echoed ... for those in the grips of this crippling disease, today on// ... is time to take the bull by its horns and evolve ... ,Alzheimer’s is a degenerative disease of the central nervous system ...
... revealed that vitamin shots may be beneficial in preventing severe ... there exists no effective treatment for the chronic progressive phase ... ,The Children's Hospital Boston study appearing in ... that giving them a type of vitamin B3 known as ...
Cached Medicine News:Health News:Stroke Linked to High Pollution Levels 2Health News:World Alzheimer’s Day: In Memory of Those With 'Memory Loss 2Health News:World Alzheimer’s Day: In Memory of Those With 'Memory Loss 3Health News:Vitamin Shots to Combat MS Pain 2
... HCS INTERACTANT is ... system. Financial applications include ... human resources and comprehensive ... financial applications are designed ...
... (Nitrogen) powder reagent once reconstituted offers the ... stability to help maximize laboratory productivity, minimize ... time. The patented technology of the Infinity ... shelf life and stability once reconstituted that ...
... The Infinity Triglycerides single liquid ... the convenience of single liquid stability ... operator error and provide quick result ... the Infinity Triglycerides reagent provides a ...
... Creatinine single liquid stable reagent offers ... single liquid stability to help maximize ... provide quick result turnaround time. The ... reagent provides a long shelf life ...
Medicine Products: