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:6/26/2016)... ... June 26, 2016 , ... ... they have been diagnosed with endometriosis. These women need a treatment plan to ... a comprehensive approach that can help for preservation of fertility and ultimately achieving ...
(Date:6/25/2016)... ... , ... First Choice Emergency Room , the largest network of independent ... Director of its new Mesquite-Samuell Farm facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
(Date:6/24/2016)... Fla. (PRWEB) , ... June 24, 2016 , ... Global ... Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition ... Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this year’s ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented its first-ever ... Medicine conference in Ponte Vedra Beach, FL. The awards honor the outstanding work ... Practice and Pediatric Emergency Medicine Practice. , “With this award, we recognize ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016  MedSource announced ... as its e-clinical software solution of choice.  This ... best possible value to their clients by offering ... The preferred relationship establishes nowEDC as the EDC ... for MedSource,s full-service clients.  "nowEDC has long been ...
(Date:6/23/2016)... Calif. , June 23, 2016 Any dentist ... many challenges of the current process. Many of them do ... of the technical difficulties and high laboratory costs involved. And ... to offer it at such a high cost that the ... it. Dr. Parsa Zadeh , founder of ...
(Date:6/23/2016)... June 23, 2016  In a startling report released today, ... residents by lacking a comprehensive, proven plan to eliminate prescription opioid ... ranking of how states are tackling the worst drug crisis in ... states – Kentucky , New Mexico ... . Of the 28 failing states, three – ...
Breaking Medicine Technology: