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:4/20/2017)... , April 20, 2017 Research and ... Pharmaceutical Contract Manufacturing Services Market Analysis By Service (Manufacturing, Research), ... Forecasts, 2014 - 2025" report to their offering. ... The Latin American pharmaceutical ... billion by 2025 Low drug registration cost in ...
(Date:4/19/2017)... The Mobile X-Ray product segment is the most ... the forecast period Mobile X-Ray segment is the ... X-Ray devices market, which is estimated to be valued at ... CAGR of 7% over the forecast period. Mobile X-Ray segment ... US$ 100 Mn in 2017 over 2016. The segment,s revenue ...
(Date:4/19/2017)... Global Prostate Cancer Therapeutics Market: Overview ... cancer therapeutics market analyzes the current and future ... prostate cancer, launch of promising emerging therapies, as ... drugs & therapeutic biological products, and high growth ... side effects are some of the drivers expected ...
Breaking Medicine Technology:
(Date:4/28/2017)... ... April 28, 2017 , ... Datta ... M.D. has joined the revolutionary endoscopic practice under Dr. Datta. Patel is a ... Pain Medicine. The patented, revolutionary eDiscSculpt Technique created and used by Datta Endoscopic ...
(Date:4/28/2017)... ... April 28, 2017 , ... People are starting to ... “Wearing a hearing aid doesn’t have the stigma it had when great-grandpa wore his ... of Greater Boston, in a NALA North American Speaker Series (NASS) segment. ...
(Date:4/28/2017)... ... April 28, 2017 , ... ... the Brooke Grove Foundation implement a Microsoft Dynamics GP solution that integrates to ... ERP expert that specializes in long-term care, Brooke Grove now has the capability ...
(Date:4/28/2017)... ... 2017 , ... Christie Medical Holdings, Inc. , with its market-leading ... Medical Inc. , a leader in infusion therapy and pain management. , Intravenous ... percent of hospital patients receiving a peripheral IV catheter as part of their treatment ...
(Date:4/27/2017)... ... April 27, 2017 , ... The American Brain Foundation ... Leadership in Neurology Award (PLINA). The couple joins a prestigious list of past ... Walter Mondale, actor Michael J. Fox and former U.S. Attorney General Janet Reno. ...
Breaking Medicine News(10 mins):