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:7/24/2014)... -- A novel combination of microscopy and data processing ... Ridge National Laboratory an unprecedented look at the surface ... electrochemical properties. , The research team led by ... of a perovskite manganite, a complex material that exhibits ... understand surface behavior could benefit researchers who are interested ...
(Date:7/24/2014)... equipment, trained personnel, and detection dogs to safeguard ... A revolutionary new electronic chip with nano-sized chemical ... easier. , The groundbreaking nanotechnology-inspired sensor, devised by ... School of Chemistry and Center for Nanoscience and ... picks up the scent of explosives molecules better ...
(Date:7/24/2014)... July 24, 2014 Research and Markets ... Cell Culture Market 2014-2018" report to their offering.  ... Cell culture is the in vitro growth of plant ... cell studies, and biopharmaceutical production. Cell culture is a ... culture instruments and cell culture consumables are necessary for ...
(Date:7/24/2014)... Francisco, CA (PRWEB) July 24, 2014 ... to be semi-finalists in Livestrong’s Big C Competition. Out ... Health are each headed to the semi-final round. In ... Livestrong’s exclusive three-month accelerator program, complete with mentoring from ... , As part of the angelMD commitment to ...
Breaking Biology Technology:ORNL study reveals new characteristics of complex oxide surfaces 2Nano-sized chip 'sniffs out' explosives far better than trained dogs 2Global Cell Culture Market 2014-2018: Key Vendors are Becton, Dickinson and Co, EMD, GE Healthcare, Lonza Group, Sigma Aldrich and Thermo Fisher Scientific 23 angelMD Startups Make Livestrong Big C Semi-finals 2
... Madison, Wis. Ten $1,000 scholarships and a top ... for young entrepreneurs in a business-plan competition sponsored by ... Young Entrepreneur Foundation . , ,The contest, named Plan for ... students until May 31. They'll be judged by an independent ...
... now are legally obligated to notify customers when their ... require businesses to rethink the way they both protect ... 164, signed into law Thursday by Governor Jim Doyle, ... typically occurs when computer systems are hacked, when dishonest ...
... nation in the number of Sloan Foundation Fellowships in ... year is up to seven, from the two Sloans ... on young researchers in the fields of chemistry, computer ... Fellowships carry a two-year, $45,000 stipend. , ,The winners ...
Cached Biology Technology:Businesses can't hide personal information losses, theft 2UW-Madison has 7 Sloan research fellows, top in nation 2
(Date:7/24/2014)... a smog-free Los Angeles, where electric cars ply silent ... on heat from beneath the earth, from howling winds ... Stanford study finds that it is technically and economically ... powered by clean, renewable energy. Published in Energy ... inexpensive and reliable energy supply in California that could ...
(Date:7/24/2014)... TORONTO, June 24, 2014 Some sticky research out ... fight against a certain species of toxic grass fungus: ... this month,s Biology Letters , "Ungulate saliva inhibits ... when applied to red fescue grass (which hosts a ... results in slower fungus growth and less toxicity. , ...
(Date:7/24/2014)... of researchers has developed a new nanoscale agent for ... for assessing the function and properties of the GI ... and treatment of gut diseases. , Illnesses ... and inflammatory bowel disease all occur in the intestine ... with diseases such as diabetes and Parkinson,s. , ...
Breaking Biology News(10 mins):Stanford study shows how to power California with wind, water and sun 2Stanford study shows how to power California with wind, water and sun 3Stanford study shows how to power California with wind, water and sun 4Moose drool inhibits growth of toxic fungus: York U research 2New imaging agent provides better picture of the gut 2
... August 13, 2012 ─ (BRONX, NY) ─ Scientists at ... made a discovery involving mice and humans that could mean ... cancer, are a step closer to new treatment options. Their ... "We have discovered that a gene called HLX is expressed ...
... temperatures of the atmosphere are rising; the average temperatures ... sensititvely to these changes. The transitional zones between shallow ... store a huge amount of methane hydrates in the ... low temperatures and under high pressure. When the water ...
... up to 50 per cent of chocolate,s fat content with ... much of the cocoa butter and milk fats that go ... measuring under 30 microns in diameter. , They infused orange ... what is known as a Pickering emulsion. , Crucially, the ...
Cached Biology News:Gene discovery could improve treatment for acute myeloid leukemia 2Are methane hydrates dissolving? 2Fruity science halves fat in chocolate 2
Immunogen: Purified native p24 from strain IIIB. Storage: -20 C, Avoid Freeze/Thaw Cycles...
EDG-1CT (endothelial cell differentiation gene-1, C terminal)...
Request Info...
... Kir2.1 protein. The epitope is specific ... in any other known protein.,SPECIES REACTIVITIES: ... in rabbit, bovine, porcine and guinea ... rat and mouse (17/19 residues) and ...
Biology Products: