[Federal Register Volume 62, Number 18 (Tuesday, January 28, 1997)]
[Notices]
[Pages 4069-4071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2062]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health.

ACTION: Notice.

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    The inventions listed below are owned by agencies of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for U.S. companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804 (telephone 301/496-7057; fax 301/402-0220). An 
signed Confidential Disclosure Agreement (CDA) will be required to 
receive copies of the patent applications.

Immunotoxin (MAB-RICIN), for the Treatment of Focal Movement 
Disorders

J Hott, R Youle, M Hallet, M Dalakas (NINDS)
Serial No. 60/027,458 filed 19 Sep 96
Licensing Contact: Stephen Finley, 301/496-7735 ext 215

    This invention describes the use of an immunotoxin designed to 
treat focal dystonias that are currently being treated by injections of 
botulinum toxin (BTX) or by surgical myectomy. The immunotoxin (ITX) is 
prepared from a monoclonal antibody (MoAb35), specific to the nicotinic 
acetylcholine receptor in skeletal muscle, and is covalently linked to 
the toxin, ricin. ITX utilizes ricin's alpha chain and beta chain for 
its improved potency. ITX's potency was demonstrated by intramuscular 
injections into a rat model. The effects of intermuscular injections of 
ITX were compared to that of BTX. Even lower doses of ITX proved more 
effective and longer lasting than BTX in weakening muscle. The ITX 
selectively removed muscle fiber at the injection sites. It is believed 
that ITX may have clinical applications to those patients who have 
become refractory to BTX, or when used in combination or in place of 
BTX. In addition to the use of ITX in the treatment of all focal 
muscular spasms, ITX may prove useful in the treatment of other 
disorders of muscular spasms such as blepharospasms, cervical dystonia, 
hand dystonia, limb dystonia, hemifacial spasm, bruxism, strabismus, VI 
nerve palsy, for spasmodic, dysphonia, and oromandibular dystonia. 
(portfolios: Central Nervious System--Therapeutics, neurological, 
other; Central Nervous System--Therapeutics, neurological, muscle 
relaxants; Internal Medicine--Therapeutics, other)

Methods and Compositions for p300/CBP-Associated Transcriptional 
Co-Factor (P/CAF)

Y Nakatani, B Howard (NICHD)
Serial No. 60/022,273 filed 23 Jul 96
Licensing Contact: Ken Hemby, 301/496-7735 ext 265

    The adenoviral oncoprotein E1A induces cell transformation by 
binding to various cellular components, such as the products of the 
retinoblastoma and p300/CBP gene families. This invention provides a 
transcriptional co-factor, p300/CBP-associated factor (P/CAF), which 
has intrinsic histone acetylase activity and also competes with E1A for 
binding to cellular targets. Also provided are methods of screening for 
compounds that affect P/CAF activity. Methods for directed gene therapy 
to provide functional wild-type or mutant P/CAF to cells producing 
varying levels of P/CAF protein are also provided. (portfolios: 
Cancer--Diagnostics; Cancer--Therapeutics, biological response 
modifiers; Devices--Research Tools and Materials, biologicals and 
chemicals)

Conformationally Locked Nucleoside Analogs

VE Marquez, JB Rodriquez, MC Nicklaus, JJ Barchi Jr, MA Siddiqui (NCI)
Serial Number 08/311,425 filed 23 Sep 94 (with priority to 24 Sep 93) 
and

Conformationally Locked Nucleoside Analogs as Antiherpetic Agents

VE Marquez, MC Nicklaus, JJ Barchi Jr, JB Rodriguez, MA Siddiqui (NCI)
Serial Number 60/023,565 filed 07 Aug 96
Licensing Contact: Robert Benson, 301/496-7056 ext 267


[[Page 4070]]


    These inventions concern novel nucleoside analogs comprising 
carbocyclic-4', 6'-cyclopropane-fused-2', 3'-derivatives of ribo, 
deoxyribo and dideoxyribo purines and pyrimidines, and the 
corresponding nucleotides. The first patent application describes an 
anti-HIV utility. It has been foreign filed as PCT/US94/10794. The 
second application describes a new utility of the deoxyribo derivatives 
of the first application, namely as anti-Herpes Virus agents. The 
thymidine analog, in particular, showed good activity against Herpes 
Simplex Type 1 and Herpes Simplex Type 2 viruses, and Epstein-Barr 
virus as shown in an in vitro assay. It showed better antiherpes 
activity than acyclovir in a plaque reduction assay. Descriptions of 
the invention are to be found in Rodriguez et al., Tetrahedron Letters 
34: 6233-6236, 1993; Rodriguez et al., J. Medicinal Chemistry 37: 3389-
3399, 1994; Siddiqui et al., Nucleosides Nucleotides 15: 235-250, 1996 
and Marquez et al., J. Medicinal Chemistry 39: 3739-3747, 1996. 
(portfolio: Infectious Diseases--Therapeutics, anti-viralsa, AIDS)

Long Distance Sequencer Method: A Novel Strategy for Large DNA 
Sequencing Projects

K Hagiwara, CC Harris (NCI)
Serial No. 60/017,569 filed 15 May 96
Licensing Contact: Leopold J. Luberecki, Jr., 301/496-7735 ext 223

    The current invention represents an improvement over existing 
technologies used in sequencing long fragments of DNA. Existing 
technologies allow for the sequencing of a 10 kb fragment of DNA in two 
to three months; the present invention allows for such sequences to be 
obtained in two to three weeks. Specifically, the method consists of 
the cloning of a long (5 kb or longer) fragment of DNA into an 
appropriate vector, followed by the generation of a series of shorter 
fragments by a number of restriction digests. A ``vectorette unit'' is 
then ligated to each restriction fragment. This vectorette unit is an 
oligonucleotide 53 bases in length, and has a unique sequence which is 
not found in the human genome. Through use of the vectorette as a 
``known end,'' together with a specific primer, the DNA is amplified 
via PCR and directly sequenced using current technologies. The 
investors have successfully used this method to sequence a 35 kb 
fragment of DNA.
    This method appears to represent four key advantages over existing 
sequencing methods. First, the sequence of a long fragment of DNA can 
be obtained far more rapidly than is currently possible. Second, as 
multiple cloning steps are not necessary, it is easier to perform. 
Third, a much smaller amount of DNA is needed for this method than is 
necessary when using currently available sequencing techniques. Fourth, 
because of its organized way of sequencing, one can clearly identify 
the region being sequenced. (portfolio: Devices/Instrumentation--
Research Tools and Materials)

Hepatitis B Core Antigen Fusion Proteins as Tumor Vaccines

LW Kwak, A Biragyn (NCI)
Serial No. 60/013,839 filed 21 Mar 96
Licensing Contact: Joseph Contrera, 301/496-7056 ext 244

    Hepatitis B Core Antigen (HBcAg) represents a potentially potent 
carrier of vaccines. Embodied in this invention are a number of fusion 
proteins of HBcAg. It has been shown that HBcAg elicits a strong immune 
response, and it was thought that if one were to attach other weakly 
antigenic peptides of choice to the HBcAg protein in order to form a 
fusion protein, the antigenicity of the attached peptide of choice 
would be considerably enhanced. The fusion proteins embodied in this 
invention, which contain specific H-ras or MUC-1 (human epithelial cell 
mucin) peptides, have been shown to elicit protective anti-tumor 
immunity in vivo. This immunity is, in fact, superior to that elicited 
through immunizing with tumor antigen alone. These HBcAg fusion 
proteins, therefore, are believed to represent powerful new vaccines to 
be used toward the prevention and treatment of a wide variety of 
cancers. (portfolio: Cancer--Therapeutics, immunoconjugates Mab; 
Cancer--Therapeutics, immunoconjugates, conjugate chemistry; Cancer--
Therapeutics, immunomodulators and immunostimulants)

Substantially Pure Non-IL-2 T-Cell Growth Factors

TA Waldmann, R Bamford, E Roessler, CK Goldman, G Szakiel, JD Burton, C 
Peters, AJ Grant, J Brennan, M Moos (NCI)
Serial No. 08/572,423 filed 14 Dec 95
Licensing Contact: Jaconda Wagner, 301/496-7735 ext 284

    The invention provides isolated interleukin-T in human form, along 
with the methods for isolating the interleukin, and its respective non-
IL-2 T-Cell growth factor and antibodies.
    T cells play both regulatory and effector functions in human immune 
responses that are often mediated by interleukins. Interleukins are 
highly redundant and pleitrophic, controlling a wide range of 
functions. Abnormalities of interleukin and interleukin receptor 
systems are observed with a broad array of human diseases, including 
the forms of leukemia and autoimmune diseases such as rheumatoid 
arthritis that are caused by human T-cell lymphotropic virus-I. Thus, 
the invention could be used to treat a disorder associated with immune 
function, such as cancer, AIDS or other immunodeficiencies, by 
enhancing the immune system or, in treating an immune disorder, such as 
graft-versus-host disease, leukemia, lymphoma or an allograft 
rejection, by suppressing the immune system. (portfolio: Internal 
Medicine--Therapeutics, anti-inflammatory; Cancer--Therapeutics, 
biological response modifiers, growth factors)

Method of Preventing or Treating Disease Characterized by 
Neoplastic Cells Expressing CD40

RJ Armitag (Immunex), WC Fanslow (Immunex), DL Longo (NCI), WJ Murphy 
(NCI)
Serial No. 08/172,664 filed 23 Dec 93 and Serial No. 08/360,923 filed 
21 Dec 94 (CIP)
Licensing Contact: Joseph Contrera, 301/496-7056, ext 244

    The subject invention proposes a method for treating a mammal 
afflicted with a neoplastic disease caused by cells that express CD40. 
CD40 is a receptor protein present on B cells, monocytes, endothelial 
cells, and various carcinomas. The ligand for CD40 (CD40L) is present 
on activated T cells. CD40 has been shown to play a critical 
stimulatory role in normal B cell development. It has been previously 
demonstrated that signals that activate normal cells can lead to 
inhibition of neoplastic cells by inducing activation-induced cell 
death. Therefore, inhibition of neoplactic cell growth can be achieved 
through the use of CD40 stimulation. The invention discloses monoclonal 
antibodies to CD40, CD40 ligands, and combinations thereof. Oligomeric 
forms of CD40 ligands and fusion protein ligands are also disclosed. 
This invention is jointly owned by the National Institutes of Health 
and Immunex Corporation. All fields of use are available for licensing. 
(portfolio: Cancer--Therapeutics, immunoconjugates, Mab)

Recombinant DNA Clone Encoding Laminin Receptor

ME Sobel, LA Liotta, UM Wewer, MC Jaye, WN Drohan (NCI)
Serial No. 06/911,863 filed 26 Sep 86, which issued as U.S. Patent No. 
4,861,710 on 29 Aug 89
Licensing Contact: Raphe Kantor, 301/496-7735 ext 247


[[Page 4071]]


    A recombinant DNA clone that encodes high-affinity cell surface 
receptors for laminin, a glycoprotein component of basement membranes, 
offers an important tool for studying a variety of normal and abnormal 
cell processes including tumor metastases. These laminin receptors have 
been shown to inhibit metastases. These recombinant receptors can be 
used in diagnostic methods, to assess the content of laminin receptor 
mRNA, and to determine the pattern of laminin receptor genes in 
different tissue and tumor cell populations. (portfolio: Cancer--
Research Materials; Cancer--Diagnostics, Mab based)

    Dated: January 17, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-2062 Filed 1-27-97; 8:45 am]
BILLING CODE 4140-01-M