Navigation Links
Avaxia Biologics Receives IND Clearance from FDA to Initiate Clinical Program to Evaluate AVX-470 as Therapy for Ulcerative Colitis
Date:11/27/2012

LEXINGTON, Mass., Nov. 27, 2012 /PRNewswire/ -- Avaxia Biologics, Inc., a privately-held biotechnology company developing oral antibody drugs that act locally within the digestive tract, announced today that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for AVX-470 for the treatment of ulcerative colitis. AVX-470 is an anti-TNF polyclonal antibody and is the first clinical candidate to come from Avaxia's oral antibody platform. The Company expects to initiate a Phase 1b clinical trial of AVX-470 in patients with active ulcerative colitis in the near term.

"Clearance of the IND allows us to advance AVX-470 into clinical development, which furthers our goal of providing patients afflicted with inflammatory bowel disease with a promising new treatment option," stated Barbara S. Fox, CEO of Avaxia. "Because AVX-470 is delivered directly to the GI tract, it has a lower potential for systemic immunosuppression than injectable anti-TNF therapies while potentially retaining the proven benefits of anti-TNF antibody therapy for inflammatory bowel disease."

About AVX-470

Avaxia has created a technology platform and a broad patent portfolio around orally administered antibodies that affect targets in the digestive tract. AVX-470 is the first product from Avaxia's platform to reach clinical development. AVX-470 is a bovine polyclonal antibody to tumor necrosis factor (TNF), a pro-inflammatory protein that has been implicated in inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. Today, injectable anti-TNF antibodies are used as an effective treatment for many IBD patients, with about $2.5 billion in sales in 2011. However, as injected drugs, they suppress the immune system throughout the body, not just locally in the gastrointestinal (GI) tract, where the disease occurs. The potentially serious side effects resulting from this systemic immunosuppression warrant a "black box" warning label.

AVX-470 is administered orally, rather than injected, and is intended to remain in the GI tract where the inflammation occurs, rather than distributing throughout the body. The goal is to have a safer anti-TNF drug for IBD. This goal may be attainable because AVX-470, unlike all currently marketed antibody therapies, resists digestion and is therefore suitable for oral administration and direct delivery to the GI tract. The unique stability of AVX-470 comes from its source—the colostrum (early milk) of cows immunized with TNF. Bovine colostral antibodies are naturally resistant to digestion.

About Avaxia Biologics

Avaxia is developing orally administered antibody therapeutics that act locally within the digestive tract. Our lead product is AVX-470, an oral antibody against tumor necrosis factor  for inflammatory bowel disease. Avaxia also has programs in GI acute radiation syndrome, celiac disease, oral mucositis and diabetes.

 


'/>"/>
SOURCE Avaxia Biologics, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Avaxia Biologics is Awarded U.S. Patent for Antibody Therapy for Modulating Function of Intestinal Receptors and Methods of Treating Diabetes and Obesity
2. Avaxia Biologics Announces Appointment of Michael D. Rivard as VP Corporate Development
3. Avaxia Biologics is Awarded U.S. Patent for Method to Treat Radiation Damage to the Digestive Tract and Mucositis Caused by Radiation
4. Cell Culture - Rising Demand for Biologics and Growing Visibility of Approval Pathway for Biosimilars will Create Growth Opportunities
5. Oncobiologics and Boston Oncology Team Up to Deliver Biosimilar Therapies for Cancer and Immune Disease to Middle East and North African Markets
6. Synthetic Biologics Initiates Development of Monoclonal Antibodies for Treatment of Acinetobacter Infections
7. South and Central America Orthopedic Devices Market Outlook to 2018 - Arthroscopy, Cranio Maxillofacial Fixation (CMF), Hip Reconstruction, Knee Reconstruction, Spinal Surgery, Orthobiologics, Trauma Fixation and Others
8. CMC Biologics Establishes Commercial Presence in Japan through Strategic Agreement with Innomedica
9. Robert G. Savage, Former Worldwide Chairman, Johnson & Johnsons Pharmaceuticals Group, Joins Board of Nuovo Biologics, LLC
10. CMC Biologics Announces Mark W. Sawicki as Vice President, Global Business Development
11. Brazil Orthopedic Devices Market Outlook to 2018 - Arthroscopy, Cranio Maxillofacial Fixation (CMF), Hip Reconstruction, Knee Reconstruction, Spinal Surgery, Orthobiologics, Trauma Fixation and Others
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016 Bracket , a leading clinical trial ... clinical outcomes platform, Bracket eCOA (SM) 6.0, at the ... – 30, 2016 in Philadelphia , Pennsylvania.  ... Assessment product of its kind to fully integrate with RTSM, ... eCOA 6.0 is a flexible platform for electronic clinical outcomes ...
(Date:6/23/2016)... , June 23, 2016 Revolutionary ... Oticon , industry leaders in advanced audiology ... of Oticon Opn ™, the world,s first internet ... possibilities for IoT devices.      (Photo: ... introduces a number of ,world firsts,: , ...
(Date:6/23/2016)... Tenn. , June 23, 2016 /PRNewswire/ ... automating, integrating and transforming the patient payment ... of several innovative new products and services ... of its revenue cycle offerings. These award-winning ... more efficient workflows, remain compliant in an ...
Breaking Medicine Technology:
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
(Date:6/24/2016)... ... ... makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum ... by 2020 and then adjusting it yearly to increase at the same rate as the ... wage floor does not erode again, and make future increases more predictable. , The company ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital Partners, LLC ... by obtaining investment capital for emerging technology companies. SCP has delivered investment ... resulted in more than a million dollars of capital investment for five companies. ...
(Date:6/24/2016)... ... ... Finally, a bruise cream that really works. Originally designed to reduce ... post-surgical treatment plans of a variety of other procedures including, but not limited to, ... bruising and causes a rapid resolution of bruising and inflammatory changes compared to no ...
(Date:6/24/2016)... ... 2016 , ... Dr. Seema Daulat, a native Texan and University of Texas ... as of July 13, 2016. , Dr. Daulat earned her Doctorate of Medicine (MD) ... volunteered at the Agape Clinic serving Dallas’ underprivileged community. , Following medical school, Dr. ...
Breaking Medicine News(10 mins):