Navigation Links
BioVex Announces Regulatory Clearance to Commence a Clinical Study With ImmunoVEX HSV2; A Vaccine Candidate for Genital Herpes

WOBURN, Mass., Aug. 20 /PRNewswire/ -- BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, today announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted BioVex's Clinical Trial Application to conduct a Phase I clinical study testing the safety and immunogenicity of its lead infectious disease candidate for genital herpes, ImmunoVEX HSV2.

ImmunoVEX HSV2 is a novel live-attenuated vaccine which has been rationally designed to remove the genes that allow herpes virus to avoid the immune system. This should allow the immune system to recognize and mount a powerful immune response against the causative agent of genital herpes. In preclinical studies, ImmunoVEX HSV2 completely prevented all symptoms of genital herpes and triggered a powerful immune response, suggesting that ImmunoVEX HSV2 may be more potent than other HSV-2 vaccines for which data has been published.

BioVex's Founder and Chief Technology Officer, Dr. Robert Coffin, commented:

"Genital herpes is a significant and growing public health issue. All previous attempts to develop either a prophylactic or therapeutic vaccine have either failed or have shown efficacy in only a very limited proportion of the population. We believe that this vaccine, based on a new understanding of HSV biology, has the potential to substantially advance the field. Accordingly, today's news is a significant milestone towards realizing this potential."

About Genital Herpes

At least 45 million people over the age of 12 in the United States have been infected with HSV-2, the cause of genital herpes, according to the Centers for Disease Control and Prevention. There is currently no cure for genital herpes and the standard treatment protocol includes daily suppressive therapy and antiviral medications.

About BioVex

BioVex is a privately held biotechnology Company based in Woburn, MA. The Company is developing a new class of potent biologics for the treatment of cancer and prevention of infectious disease.

The Company's lead cancer technology platform, OncoVEXGM-CSF is a first-in-class oncolytic, or cancer destroying virus technology. OncoVEXGM-CSF works by: replicating and spreading within solid tumors, causing the death of cancer cells; while stimulating the immune system to destroy metastatic deposits. Both modes of action have been clearly validated in the clinic, where multiple patients with metastatic disease progressing at enrollment have been declared disease free. BioVex believes OncoVEXGM-CSF has the potential to become a leading standard of care in the treatment of many solid tumors based on the strength of clinical data generated to date, coupled with a benign side effect profile.

BioVex is currently completing a Phase II clinical trial of OncoVEXGM-CSF for melanoma and Phase I/II clinical trials for head & neck cancer and pancreatic cancer. Earlier this year, the Company announced that the FDA approved the design of a single, pivotal Phase III clinical trial evaluating OncoVEXGM-CSF in previously treated patients with metastatic melanoma under the Special Protocol Assessment (SPA) procedure and plans to make a second SPA submission for head & neck cancer later in the year. BioVex intends to begin its Phase III trial for OncoVEXGM-CSF in melanoma in the first quarter of 2009.

For further information, please go to

Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. BioVex Reports Positive Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncology Meeting
2. BioVex to Report Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncology Meeting
3. BioVex Agrees SPA With the FDA for a Pivotal Study With OncoVEX(GM-CSF) in Metastatic Melanoma and Announces Presentation of Phase II Results at ASCO
4. AstraZeneca Announces Innovative New Partnership With Singapore Institutions to Develop Anti-Cancer Compounds
5. Clinical Trials Bootcamp Announces Inaugural Meeting
6. Nuvelo Announces Positive Phase 1b Proof-of-Concept Data With Anticoagulant NU172
7. NewCardio Announces Positive Results From Third Clinical Validation Study
8. Medarex Announces Initiation of Phase 2 Clinical Development Program for the Treatment of Lupus
9. Lixte Biotechnology Holdings Announces Filing of a New Patent Application for the Use of Novel Compounds as Potential Treatment for Neurodegenerative Diseases
10. Cell Therapeutics Announces that the European Organization for Research and Treatment of Cancer Completes Enrollment in Phase II Clinical Trial of Brostallicin as First Line Therapy for Advanced or Metastatic Soft Tissue Sarcoma
11. Lixte Biotechnology Holdings Announces That Novel Compounds Being Developed as Potential Treatments for Brain Tumors Have Positive Activity in a Mouse Model of Human Pancreatic Cancer
Post Your Comments:
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, ... -based mobile pulmonary function testing company, is now able to perform ... developed by ndd Medical Technologies , Inc. ... in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL ... can get any needed testing done in the comfort of her ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
(Date:6/23/2016)... 2016  In a startling report released today, National Safety ... lacking a comprehensive, proven plan to eliminate prescription opioid overdoses. ... how states are tackling the worst drug crisis in recorded U.S. ... Kentucky , New Mexico , ... Of the 28 failing states, three – Michigan ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, ... the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where ... city’s history as home to some of the world’s leading providers of cereal and ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women ... diagnosed with endometriosis. These women need a treatment plan to not only alleviate ... that can help for preservation of fertility and ultimately achieving a pregnancy. The ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, ... Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms ... Final Cut Pro X . Simply select a ProHand generator and drag it above ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, ... at Work award to iHire in recognition of their exemplary accomplishments in worksite health ... annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. ...
(Date:6/24/2016)... , ... June 24, 2016 , ... June 19, 2016 ... dangers associated with chronic pain and the benefits of holistic treatments, Serenity Recovery ... are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder ...
Breaking Medicine News(10 mins):