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:2/4/2016)... -- Frontier Pharma: Chronic Obstructive Pulmonary Disease (COPD) ... Chronic Obstructive Pulmonary Disease (COPD) is a ... airways and lungs. Persistent breathing difficulties and repeated ... of the leading causes of morbidity and the ... is linked to cumulative exposure to risk factors, ...
(Date:2/4/2016)... 2016  Aethlon Medical, Inc. (Nasdaq: AEMD ... to treat life-threatening diseases, today announced results for ... 31, 2015. --> ... in our last quarterly call, we strategically advanced ... objective to establish the Aethlon Hemopurifier® as a ...
(Date:2/4/2016)... , Feb. 4, 2016  Blueprint Medicines Corporation ... and developing highly selective investigational kinase medicines for ... appointment to its board of directors of ... nearly 30 years of industry-related experience. ... Blueprint Medicines. "Lonnel,s strong strategic experience developing and ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... 05, 2016 , ... In sleep, when the defenses of the day are ... of patients with eating disorders is significant self-criticism, and consequently these patients experience this ... regarded as maladaptive means for coping with this unease, but also leads to a ...
(Date:2/5/2016)... ... 2016 , ... California Mobile Kitchens , a company ... latest mobile kitchen model, featuring customizable stainless steel interiors and a new, 26-foot ... use anywhere in the U.S. Many of their units can be seen at ...
(Date:2/5/2016)... ... 05, 2016 , ... Calls Blacklist has just been updated by mobile app ... the developer has fixed known bugs within the app. Calls Blacklist allows its users ... not consuming any of their device’s battery power or memory. It provides a powerful ...
(Date:2/5/2016)... ... ... –This week, Atascadero water heater company First Call Plumbing has ... the report, click here or see below. , There are two ... cons, the type chosen is almost entirely up to personal preference. However, tankless water ...
(Date:2/5/2016)... ... ... one is tired of trying to cram belongings into spare space that just isn’t there, ... unit, but before hastily spending money on a unit, take these tips into consideration. , ... one is often not told when utilizing these services are some tips on how to ...
Breaking Medicine News(10 mins):