Navigation Links
BioVex Agrees SPA With the FDA for a Pivotal Phase III Study With OncoVEX (GM-CSF) in Head and Neck Cancer
Date:9/15/2009

WOBURN, Mass., Sept. 15 /PRNewswire/ -- BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX (GM-CSF), for the first-line treatment of patients with squamous cell cancer of the head and neck.

The study is the second the Company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex's first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal Phase III trial.

Patients with head and neck cancer often present with locally advanced, bulky disease that is too large, or too close, to vital organs to remove surgically. These patients typically undergo combination radiation and chemotherapy treatment, in some cases with additional surgery. Patients who present with tumor-containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years.

Philip Astley-Sparke, President & CEO, for BioVex said:

"The announcement of our second SPA governing a Phase III study demonstrates the breadth of the commercial opportunity with OncoVEX (GM-CSF). In addition to treating metastatic disease as is the intention in our ongoing Phase 3 study in melanoma, following multiple systemic responses in Phase II, OncoVEX (GM-CSF) also has considerable potential utility in treating discrete solid tumor masses across multiple indications including those that are poorly served by radiation. As with tumors like head and neck cancer where loco-regional progression is the primary cause of treatment failure, treating discrete tu
'/>"/>

SOURCE BioVex Inc
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. BioVex Commences OncoVEX (GM-CSF) Phase 3 Trial in Metastatic Melanoma
2. BioVex Raises $40 Million in First Close of Series F Financing
3. BioVex to Present at the UBS Global Life Sciences Conference
4. BioVex Closes Second Round of Series E Financing
5. BioVex Appoints Genzyme Executive, Jan van Heek, as Chairman of the Board of Directors
6. BioVex Appoints Dr. Thaddeus Pullano as VP, Quality Assurance
7. CardioDynamics Agrees to be Acquired by SonoSite for $1.35 Per Share
8. MannKind Agrees with Pfizer on the Purchase of Frankfurt Insulin Manufacturing Plant
9. PharmaNet Development Group Agrees to be Acquired by JLL Partners
10. AEterna Zentaris Agrees to Sell Cetrotide(R) Royalty Stream for $52.5 Million to Cowen Healthcare Royalty Partners
11. Sosei Agrees Terms With ASKA for Commercialisation of SOH-075 (NorLevo(R))
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... NEW YORK , Dec. 24, 2014 /PRNewswire/ ... company advancing patient care in critical areas, announced the ... of common stock, and warrants to purchase up to ... offering price of $4.00 per share and $.01 per ... of $5.00, are exercisable immediately, and expire 5 years ...
(Date:12/24/2014)... GMO corn cases filed across the ... in the process of being consolidated in a Kansas ... In Re: Syngenta AG MIR 162 Corn Litigation, MDL ... District of Kansas. , Management of the Syngenta GMO ... U.S. District Judge John W. Lungstrum.* , As a ...
(Date:12/24/2014)... December 23, 2014 According to Ross Selinger, ... Affiliate of ITRA Global, the national office market continues to ... This is evidenced by the third quarter’s surprising 3.9% ... Low energy costs have held inflation down and the ... is the housing market remaining soft. , This solid economic ...
(Date:12/24/2014)... San Diego, CA (PRWEB) December 23, 2014 ... Contest where their Twitter followers can submit their ... for themselves and their lab mates. , For those ... beloved lab mates, the Pipette.com Holiday in the Lab ... encourages Pipette.com Twitter followers to send pictures ...
Breaking Biology Technology:PlasmaTech Biopharmaceuticals, Inc. Announces Closing of Public Offering 2PlasmaTech Biopharmaceuticals, Inc. Announces Closing of Public Offering 3Carey Danis & Lowe Reports on Syngenta GMO Corn Transfer Order 2ITRA Global Reports Long Island Is Out of Sync With The National Office Market 2ITRA Global Reports Long Island Is Out of Sync With The National Office Market 3Major Pipette Distributor Pipette.com Announces their Holiday in the Lab Contest 2
... Friday announced the availability of RFID 360, a ... major retailer and Department of Defense compliance. RFID 360 ... RFID implementation environment and schedule. , ,The first software ... others, is RFID Data Manager. Data Manager is designed ...
... engine company, set the business world abuzz with the ... so it released data about its financial performance that ... analysts however, criticized the company and its founders for ... proposed for its stock offering. While some trepidation is ...
... Note: The Wisconsin Technology Network is committed to ... and deployment of technology. We salute the administration and ... help spread the adoption health technology. If you ... should attend the following event. , ,The ...
Cached Biology Technology:RedPrairie announces RFID 360 compliance software 2Why Google Matters 2Why Google Matters 3The doctor is in: Thompson prescribes better health information technology 2The doctor is in: Thompson prescribes better health information technology 3The doctor is in: Thompson prescribes better health information technology 4
(Date:12/11/2014)... 2014  That blood pressure plays a role in human ... the medical term for high blood pressure – was first ... inflatable cuff that,s used in measuring blood pressure was invented ... new about hypertension, its triggers and its effects. In fact, ... and the best ways to treat it. For ...
(Date:12/10/2014)... Dec. 9, 2014  Valencell, a leader in performance ... a staggering demand from its licensees for highly accurate, ... is not solely coming from fitness and health sectors, ... "A wearable is only as useful as the ... the ultimate driver in long-term mass consumer adoption of ...
(Date:12/10/2014)... DUBLIN , Dec. 08, 2014 Research ... announced the addition of the "Biometrics Market ... http://photos.prnewswire.com/prnh/20130307/600769 ... for projects such as rural banking and upgradation ... major trends witnessed in the market. Besides the ...
Breaking Biology News(10 mins):Research points to need for new approaches to treatment of high blood pressure 2Research points to need for new approaches to treatment of high blood pressure 3Research points to need for new approaches to treatment of high blood pressure 4Wearable Technology Products Demand Highly Accurate Biometric Technology 2Biometrics Market in Japan 2014-2018: Key Vendors are DDS, Fujitsu, Hitachi and NEC 2
... of chromosomes, and even a small change in this structure ... can lead to severe physical impairment. So it,s no ... frequently a contributing factor, says Prof. Ron Shamir of the ... Now Prof. Shamir and his former doctoral students Michal Ozery-Flato ...
... release is available in Spanish . ... because of their characteristics, produce a certain amount of social ... fact that they are subjected to moral conflicts and ethical ... very necessary from a social perspective, as in the case ...
... Institute scientist Matthias von Herrath, M.D., a world leader in ... seeing his discoveries translated into new therapies to better treat ... may soon get his chance as head of a new ... in 2012 by Novo Nordisk, a global healthcare company specializing ...
Cached Biology News:Patterns of chromosome abnormality: The key to cancer? 2Moral imagination as a key to overcoming work-related stigmas 2La Jolla Institute scientist takes quest to conquer Type 1 diabetes to the next level 2
Artisan™ Wash Solution (x 50) Additional Information: EU regulatory status: CE US regulatory status: IVD ...
... Secondary Detection System is intended for use ... Antibody reagents, which contain rat and goat ... by light microscopy in paraffin-embedded tissues. The ... also be used with other rat or ...
... Lower operational costs. More efficient interfacing ... limited sample volumes. Industry demands for ... using microbore chromatography for routine applications. ... adequately satisfy the need to operate ...
... The Hepta adaptor for the PDS-1000 He ... be transformed than the standard system. It fits ... system, where it splits the helium shock wave ... gold or tungsten particles over this larger area, ...
Biology Products: