 |
Please Note: The technology listed below is not available to the public at this time. This technology is in the early stage of research and requires further development before it is ready for the marketplace. The VA is currently in the process of identifying potential companies who may be interested in licensing and/or further developing the technology through Cooperative Research and Development Agreements (CRADA). Through cooperative research initiatives such as these, it is our hope and goal that commercial products will be fully developed and made available to benefit veterans and others.
VA TECHNOLOGY OPPORTUNITY BRIEF
Method of Treating Autism and Therapies for Gastrointestinal and Neurological Disorders
OPPORTUNITY:
The Department of Veterans Affairs (VA) is seeking a commercial partner to
license or further develop this technology through a Cooperative Research and
Development Agreement (CRADA).
BACKGROUND:
Disruption of gastrointestinal flora by the use of antimicrobial agents or
in relation to an immune deficit, or poorly developed flora in young infants,
may lead to proliferation of certain pathogenic microorganisms in one or more
regions of the gastrointestinal tract. Production of toxins, particularly neurotoxins
or toxic metabolic products, by such microorganisms may mediate these neurological
disruptions.
It has been noted that certain neurological diseases have accompanying gastrointestinal manifestations, particularly constipation and diarrhea. This suggests the possibility that an intestinal microorganism may be the cause of both aspects of the disease. In turn, this implies that appropriate antimicrobial therapy might lead to improvement in both gastrointestinal and the neurological aspects. This has been demonstrated in late onset autism (response has been demonstrated with the administration of oral vancomycin and metronidazole), and there are isolated anecdotal reports of improvement in patients with Alzheimer’s disease, schizophrenia, and Parkinson’s disease. Additional diseases that might have similar pathogenesis include attention deficit hyperactivity disorder (ADHD), depression, bipolar disorder, Whipple’s disease, Tourette’s syndrome, Asperger’s syndrome, and Rhett’s syndrome. Disrupted gut microbial flora can also lead to antimicrobial-associated diarrhea and play a role in irritable bowel syndrome and inflammatory bowel disease (ulcerative colitis and Crohn’s disease).
TECHNOLOGY OVERVIEW:
The VA has identified certain bacteria that may play a role in the neurological disorders mentioned above, and offers options for prevention and treatment. The invention comprises a method of administering to the patient an antimicrobial in an amount sufficient to inhibit or eliminate the microbial agent. The antimicrobial composition in a form of probiotic mixture can be administered alone or in combination with an antimicrobial agent, including bacteriophage, specific for an offending bacterium.
TECHNICAL MERIT:
One of the novel features of the invention is the discovery of a relationship
between gut flora and the brain and a common etiology for both gastrointestinal
and neurological disorders, which makes it possible to design common diagnostic,
therapeutic, and preventive strategies. Another feature of the invention is
a method that includes vaccinating the patient with an antigenic epitope of
the bacterium or toxin such that an immune response capable of interaction
with gut flora can be elicited upon antigen challenge from microbe proliferation
in the gut. Another novel feature of the invention is the possibility of identifying
DNA encoding a polypeptide comprising a novel toxin produced by a member of
the genus Clostridium. The invention has potential commercial applications
in preventing and treating gastrointestinal and neurological disorders mentioned
above.
IP STATUS:
A U.S. patent application (10/297,131) was filed on 10/07/03.
A CIP application (10/729,949) was filed on 12/09/03 for additional drugs/claims to 10/297,131.
This technology was posted in the Federal Register on 12/31/01, Vol. 66, No. 250, p. 67630
International patent application filed on June 05, 2001 (PCT/US01/18071)
TTP filed a continuation application on 10-30-07 (11/979,007). It is a continuation of US patent application 10/297,131
filed Dec 3, 2002 based on provisional applications 60/209,712 filed on June 5, 2000;
60/214,813 filed June 28, 2000 and 60/240,582 filed on Oct 16, 2000.
FOR MORE INFORMATION CONTACT:
Saleem Sheredos
Program Manager
Technology Transfer Program
Veterans Affairs
Office of Research & Development (12TT)
5th Floor
103 South Gay Street
Baltimore, MD 21202
202-380-5080
Fax 410.962.2141
e-mail: saleem.sheredos@va.gov