Nanotechnology Now







Heifer International

Wikipedia Affiliate Button


DHgate

Home > Press > BioVex Receives Spa for Head and Neck Cancer Study

Abstract:
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, OncoVEXGM-CSF for the first line treatment of patients with squamous cell cancer of the head and neck.

BioVex Receives Spa for Head and Neck Cancer Study

Woburn, MA | Posted on September 16th, 2009

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, with in some cases 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 OncoVEXGM-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, OncoVEXGM-CSF also has considerable potential utility in treating discrete solid tumor masses across multiple indications including those that are poorly served by radiation. In addition to tumors like head and neck cancer where loco-regional progression is the primary cause of treatment failure, treating discrete tumor masses is a major unmet need in wide range of settings. It is our belief that, as a result, this technology has the potential to provide a broadly active new modality to substantially improve patient outcomes in a variety of hard to treat tumor types."

Phase III Study Design
The Phase III study design agreed with the FDA follows directly from the design of the previous study. The Phase III study will also enroll previously untreated patients with locally advanced disease. The primary objective of the study will be to demonstrate a statistically significant increase in 2 year event free survival (i.e. relapse, progression, or death) for patients treated with chemoradiation together with OncoVEXGM-CSF as compared to patients treated with chemoradiation alone. The study will involve approximately 400 patients with approximately 200 in each arm.

Phase I/II Study Design and Results
In a Phase I/II study, OncoVEXGM-CSF was administered by direct injection, at three dose levels, into tumor containing lymph nodes in combination with standard first line chemo radiotherapy every three weeks for four cycles. All patients then went for surgery. Of the 17 patients enrolled, 16 had Stage IV N2 or N3 disease. OncoVEXGM-CSF was shown to be well tolerated with no significant side effects in addition to those associated with chemoradiation. With respect to efficacy, 93% of patients had a complete pathological response at surgery, with five patients achieving a complete response after only 2 or 3 virus doses. No patient to date has had a loco-regional recurrence in the neck at a median follow up of 30 months, and the disease specific survival rate is currently 82%.

Dr Robert Coffin, Founder and Chief Technology Officer, for BioVex, said:
"Loco-regional control is extremely important in head and neck cancer where loco regional progression is responsible for the majority of deaths. The two year loco-regional failure rate following front line treatment is around 30% with a further 20% of patients progressing at a distant site. The long term loco-regional control rate of 100% combined with the high percentage of patients that remain disease free at up to 40 months from treatment is very encouraging and provides confidence that OncoVEXGM-CSF will significantly reduce relapse rates as compared to standard therapy alone in the pivotal study recently agreed with the FDA."

About Head and Neck Cancer
Head and neck cancer accounts for 47,000 new cases (3% of all new cancer cases and 2% of all cancer deaths) in the United States annually; it is the fifth most common malignancy worldwide (an estimated 644,000 new cases annually).

Patients with locally advanced tumors are best treated with concurrent chemoradiation, with planned neck dissection indicated in certain patients. Despite aggressive treatment of locally advanced disease loco-regional recurrences develop in 30% of patients and distant metastases in 20%. Aggressive combined modality therapy may be frequently associated with debility, and numerous physical and psychological symptoms including pain, dysphagia, weight loss, disfigurement, depression, and xerostomia (dry mouth). As a result, new and improved, and less toxic therapies for head and neck cancer are urgently required.

####

About BioVex
BioVex is a privately held biotechnology company based in Woburn, MA where it also has an operational launch grade manufacturing facility. 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. OncoVEX GM-CSFdesigned to work by; replicating and spreading within solid tumors (whilst leaving healthy cells unaffected), causing the death of cancer cells; and through stimulating the immune system to destroy un-injected 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 so far generated coupled with the relatively benign side effect profile noted to date. Previous clinical trials have enrolled patients with breast cancer, melanoma, and pancreatic cancer in addition to head and neck cancer, with indications of clinical activity being observed in each. The Company recently commenced a Phase III study in metastatic melanoma following the achievement of an unprecedented proportion of durable complete remissions in a Phase II study using OncoVEXGM-CSF as stand alone therapy. An overview of the Phase II melanoma results is available on our website.

The Company's second program is a vaccine for genital herpes, ImmunoVEXHSV2, which provides complete protection in animal models of the disease. The vaccine has been authorized to commence clinical testing in the UK.

For more information, please click here

Contacts:
BioVex Inc. Inquiries
Mr Philip Astley-Sparke
President & CEO
Tel: +1 781 376 4913


Media Inquiries:
Irma Gomez-Dib
FD Life Sciences
Tel: 212-850-5761

Copyright © BioVex

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Air Bearing Stage / Systems Introduced by PI at Photonics West March 6th, 2015

Anousheh Ansari Wins the National Space Society's Space Pioneer Award for "Service to the Space Community" March 5th, 2015

Enhanced Graphene Components for Next Generation Racing Yacht March 5th, 2015

Get ready for NanoDays! March 5th, 2015

Possible Futures

European roadmap for graphene science and technology published February 25th, 2015

Quantum research past, present and future for discussion at AAAS February 16th, 2015

World’s first compact rotary 3D printer-cum-scanner unveiled at AAAS by NTU Singapore start-up: With production funded by crowdsourcing, the first unit will be delivered to the United States in March February 16th, 2015

Nanotechnology Electric Vehicle (EV) Market Analysis Report 2015: According to Radiant Insights, Inc February 13th, 2015

Nanomedicine

Patent for the Novel Cancer Therapies – Ceramide Nanoliposomes March 4th, 2015

Arrowhead to Present at 2015 Barclays Global Healthcare Conference March 4th, 2015

Democratizing synthetic biology: New method makes research cheaper, faster, and more accessible March 3rd, 2015

Pens filled with high-tech inks for do-it-yourself sensors March 3rd, 2015

Announcements

Air Bearing Stage / Systems Introduced by PI at Photonics West March 6th, 2015

Anousheh Ansari Wins the National Space Society's Space Pioneer Award for "Service to the Space Community" March 5th, 2015

Enhanced Graphene Components for Next Generation Racing Yacht March 5th, 2015

Get ready for NanoDays! March 5th, 2015

Nanobiotechnology

Experiment and theory unite at last in debate over microbial nanowires: New model and experiments settle debate over metallic-like conductivity of microbial nanowires in bacterium March 4th, 2015

Untangling DNA with a droplet of water, a pipet and a polymer: With the 'rolling droplet technique,' a DNA-injected water droplet rolls like a ball over a platelet, sticking the DNA to the plate surface February 27th, 2015

Bacteria network for food: Bacteria connect to each other and exchange nutrients February 23rd, 2015

Building tailor-made DNA nanotubes step by step: New, block-by-block assembly method could pave way for applications in opto-electronics, drug delivery February 23rd, 2015

NanoNews-Digest
The latest news from around the world, FREE




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More










ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







© Copyright 1999-2015 7th Wave, Inc. All Rights Reserved PRIVACY POLICY :: CONTACT US :: STATS :: SITE MAP :: ADVERTISE