Navigation Links
Biomodels' Oral Mucositis Expertise Speeds FDA Approval for ActoGeniX's Phase 1b Trial of AGO13 in Cancer Patients
Date:6/22/2009

ActoGeniX taps Biomodels CRO expertise in $1 billion market for cancer support care to relieve side effects of cancer treatments

WATERTOWN, Mass., June 22 /PRNewswire/ -- Biomodels LLC, a preclinical research organization specializing in cancer support care, today announced that its customized research program allowed ActoGeniX NV, a development stage biopharmaceutical company, to rapidly attain Food and Drug Administration (FDA) approval for Phase 1b clinical trials of AGO13 in cancer patients with oral mucositis.

There is currently no effective cure for the severely painful and debilitating inflammation and ulceration of the mucous membranes lining the mouth that makes eating, drinking and speaking difficult or impossible.

Oral mucositis, can affect up to 100 percent of cancer patients undergoing high dose chemotherapy.

The FDA approval permits ActoGeniX to initiate a phase 1b clinical trial in six major oncology centers in the United States. AGO13 could become the first approved therapy for oral mucositis in patients undergoing treatment of solid tumors or head/neck cancers, according to ActoGeniX.

"The speedy approval of our drug application for AGO13 from the FDA was clearly the result of our successful collaborative efforts with Biomodels scientists who worked closely with us in a complex process involving the development of innovative, high quality platforms," said Dr. Mark Vaeck, CEO of ActoGeniX.

The preclinical data package that was developed enabled us to identify how AGO13 could be used clinically, " he said. "We can now seamlessly translate Biomodels' research into our clinical trials, thus speeding up the drug development process."

Edward Fey, CEO of Biomodels said, "We are delighted that our collaboration with ActoGeniX will speed the development of an effective therapy for cancer patients suffering from the ravages of oral mucositis. Biomodels was able to provide an innovative and customized program to ActoGeniX. This close collaboration resulted in a very successful outcome."

About Biomodels

Biomodels (www.biomodels.com), a preclinical contract research organization founded in 1997, has developed and conducted more than 1000 preclinical trials for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation, therapy, and inflammatory diseases.

The company specializes in (non-GLP) predictive studies that evaluate efficacy and define mechanism of action, enabling clients to expedite the drug discovery process. Biomodels' preclinical studies anticipate clinical objectives and enable organizations to rapidly achieve preclinical milestones.

About ActoGeniX

ActoGeniX is a biopharmaceutical company focused on the development and commercialization of ActoBiotics(TM), a novel class of orally available biopharmaceuticals for the targeted treatment of severe diseases with high medical needs. ActoBiotics(TM) represent a novel concept for oral administration of therapeutic proteins, and are designed to be safer and more effective than injectable biopharmaceuticals.

ActoGeniX was founded in 2006 as a spin-off from VIB and Ghent University in Belgium. The company is headquartered in Ghent and has approximately 40 employees, half of whom are PhD's, MD's, or PharmD's.


'/>"/>
SOURCE Biomodels LLC
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. CAPHOSOL results in minimal oral mucositis and pain in head/neck cancer patients
2. Putting a name to a face may be key to brains facial expertise
3. SAFC(R) & Cherokee Pharmaceuticals(TM) Pool Expertise and Resources With Strategic Partnership For U.S. Market
4. J. Craig Venter Institute Awarded $43 Million, Five Year Contract From NIAID to Continue to Develop and Provide Sequencing, Genotyping, and Bioinformatics Expertise and Services in Infectious Diseases
5. Purolator USA Offers Canadian Customs Expertise for Medical Device Exports
6. kidneySPA Introduces A Revolutionary Approach To Dialysis Treatment Newly Opened Facility Combines "Medical" Expertise with "Spa-Like" Experience
7. Kennedy Group Applies Its Packaging Expertise to Reusable Labeling in Handling Biomedical Waste Disposal
8. My1Stop.com President Michael Del Chiaro Interviewed by Entrepreneur.com for ecommerce Expertise
9. Former Genworth and GE Long Term Care Insurance Leader Brings Unique Sales Expertise to LTC Financial Partners, LLC
10. Be Green with B. Braun: Company Shares Expertise, Environmentally Responsible Products at ASHP 2008
11. Gather and Harvard Health Publications Launch New Programs to Bring Harvard Medical School Doctors Expertise Online
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... ... (PRWEB) ... opportunity for the nation to come together to combine its ... – with its favorite fruit – apples! To celebrate National ... to join the “Apple Madness” bracket tournament – a five-week, ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... HealthPostures, the ... sending an expert sit stand solutions representative to the Minneapolis Home and Garden Show ... for the event that is garnering national attention is the Minneapolis Convention Center. ...
(Date:2/22/2017)... ... February 22, 2017 , ... ... enough to overwork even the sharpest brain. , Power On, a mental performance ... without over clocking the brain. Each capsule contains Cognizin® Citicoline, a branded form ...
(Date:2/22/2017)... MD (PRWEB) , ... February 22, 2017 , ... ... Direct secure messaging services to the largest network of hospitals, health information ... the National Coordinator for Health Information Technology (ONC-HIT) 2015 Edition Health IT Module ...
(Date:2/22/2017)... (PRWEB) , ... February 22, ... ... Adjustment solution leverages advanced data analytics to accurately understand each Medicare Advantage ... reimbursement for a given population. This new solution helps transform the HCC ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... , Feb 23, 2017 Research and Markets ... Strategies - 2016" report to their offering. ... The latest research Menopause Drugs Price Analysis and ... Menopause market. The research answers the following questions: ... clinical attributes? How are they positioned in the Global Menopause market? ...
(Date:2/23/2017)... Feb. 23, 2017 AcelRx Pharmaceuticals, Inc. ... the development and commercialization of innovative therapies for ... it will release fourth quarter and yearly financial ... 2017. AcelRx management will host an investment-community conference ... Pacific Time) on March 2 nd 2017 ...
(Date:2/23/2017)... Research and Markets has announced the addition of the ... report to their offering. ... The Global Endoscopy Market is poised to grow ... reach approximately $47.6 billion by 2025. This industry ... segments on global as well as regional levels presented in the ...
Breaking Medicine Technology: