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Federal Register / Vol. 71, No.

196 / Wednesday, October 11, 2006 / Notices 59801

DEPARTMENT OF HEALTH AND of TNFR1, not signaling mediated binding of TNFa to both TNFR1 and
HUMAN SERVICES through TNFR2. Treatment of mice with TNFR2. There is evidence that this
the P60 PLAD-Sol ameliorated inhibits the beneficial effects mediated
National Institutes of Health inflammatory joint disease with no side by TNFR2, while arresting the disease-
[HHS Reference Nos. E–095–2000/0, 1, 2,
effects in 5 different animal models of causing effects of TNFR1. This is
3 and 4] arthritis including: collagen-induced because the P60 PLAD-Sol involves the
arthritis, adjuvant and use of small soluble proteins that
Public Teleconference Regarding lipopolysaccharide induced arthritis, preferentially target only the PLAD of
Licensing and Collaborative Research and joint disease due to TNF. Therefore, TNFR1. In our models, a dose of a P60
Opportunities for: A Promising P60 PLAD-Sol may lead to novel PLAD-Sol (5 mg/kg) had similar effects
Treatment for Inflammatory Arthritis inflammatory arthritis treatments that to doses of Infliximab (10 mg/kg) and
Targeting the Pre-ligand Assembly avoid the serious side effects associated Etanercept (0.4 mg/kg) that have been
Domain (PLAD) of Tumor Necrosis with currently marketed therapeutics used clinically in the amelioration of
Factor Receptors; Michael J. Lenardo that directly block TNFa rather than arthritis. As a selective TNFR1 blocking
et al. (NIAID) TNFR1. agent, this technology may avoid the
Competitive Advantage of Our serious side effects of these currently
AGENCY: National Institutes of Health, available compounds yet have enhanced
Public Health Service, HHS. Technology
ACTION: Notice. More than 20% of the population in
the USA currently seek arthritis Patent Estate
Technology Summary treatment; of these over 2 million suffer A PCT application, filed 9 February
rheumatic symptoms. Worldwide this 2001 (WO 01/58953), has entered the
The technology is an innovative figure is close to five million people.
treatment for inflammatory arthritis that national phase in the US, EP, AU and
Existing commercially available anti- CA.
involves modulating Tumor Necrosis TNFa treatments are expensive: in the
Factor Receptor (TNFR) 1 signaling. NIH U.S. Enbrel, Remicade, and Next Step: Teleconference
scientists have discovered that the Pre- Humira all cost more than $10,000 per There will be a teleconference where
ligand Assembly Domains (PLADs) of year. In addition to this market there is the principal investigator will discuss
TNFR1 can be selectively blocked by the potential to treat other inflammatory non-confidential information
soluble P60-PLAD protein compositions based diseases such as Crohn’s Disease concerning this technology. Licensing
(P60 PLAD-Sol) which interfere with and Multiple Sclerosis. Owing to the and collaborative research opportunities
TNFR1 assembly thereby preventing the high price of these agents and their will also be discussed. If you are
inflammatory effects of TNFa both in increased use in treatment, the market interested in participating in this
vitro and in vivo. for TNFa inhibitors is expected to grow teleconference please call or email
Technology Description from $7.1 billion in 2005 to nearly $12 Mojdeh Bahar; (301) 435–2950;
billion in 2014 in the United States, OTT will then e-
Current anti-TNFa arthritis treatments Western Europe, and Japan.
rely on the use of antibodies or fusion mail you the date, time and number for
The existing TNF blockers, e.g., the teleconference.
proteins directed against TNFa to Enbrel (Etanercept—a dimeric fusion
reduce inflammation. The cytokine protein by Amgen/Wyeth), Remicade Dated: October 2, 2006.
TNFa plays a key role in the (Infliximab—a mouse chimeric anti-TNF Steven M. Ferguson,
pathogenesis of numerous autoimmune monoclonal antibody by J&J), and Director, Division of Technology Development
and inflammatory diseases including Humira (Adalimumab—a humanized and Transfer, Office of Technology Transfer,
psoriatic, rheumatoid, and septic anti-TNF monoclonal antibody by National Institutes of Health.
arthritis. It has been shown that Abbott) have been effective in the [FR Doc. E6–16735 Filed 10–10–06; 8:45 am]
blocking TNFa has a dramatic treatment of rheumatoid arthritis. They BILLING CODE 4140–01–P
therapeutic effect; however, blocking are beneficial in over 70% of patients
TNFa also blocks TNFa’s beneficial including many who have not
effects during immune responses that responded to Rheumatrex DEPARTMENT OF HEALTH AND
are mediated through TNFR2. (Methotrexate—an antimetabolite by HUMAN SERVICES
This invention involves a functional STADA); however, serious and
domain, which is essential for signaling sometimes fatal side effects have been Substance Abuse and Mental Health
involving receptors of the TNFR observed. In addition, the current costs Services Administration
superfamily including TNFR–1 (p60), of these drugs are prohibitive for many Current List of Laboratories Which
TNFR–2 (p80), FAS, TRAIL-R, LTR, patients. This technology has the Meet Minimum Standards To Engage in
CD40, CD30, CD27, HVEM, OX40 and potential to be less expensive yet more Urine Drug Testing for Federal
DR4. PLADs can be isolated as effective than existing products. Agencies
functional polypeptides which can be For arthritis sufferers who are
useful in inhibiting the first step in unresponsive to, or adversely affected AGENCY: Substance Abuse and Mental
TNFR mediated signaling, ligand- by, current inflammatory arthritis Health Services Administration, HHS.
independent assembly of members of treatments our technology is a new ACTION: Notice.
the TNFR superfamily. The ability to method of blocking inflammation that
inhibit TNFR signaling suggests that provides a more targeted action. Unlike SUMMARY: The Department of Health and
these PLAD polypeptides may be useful the currently marketed anti-TNF Human Services (HHS) notifies Federal
pwalker on PRODPC60 with NOTICES

in developing new therapeutic medications, P60 PLAD-Sol has the agencies of the laboratories currently
molecules or as therapeutic molecules potential to more effectively treat a certified to meet the standards of
themselves. broader range of inflammatory diseases Subpart C of the Mandatory Guidelines
P60 PLAD-Sol has the benefit of with no known side-effects. The current for Federal Workplace Drug Testing
selectively blocking only the signaling anti-TNF drugs directly block the Programs (Mandatory Guidelines). The

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