Grants and cooperative agreements; availability, etc.: owned; availability for licensing,

[Federal Register: July 26, 2002 (Volume 67, Number 144)]

[Notices]

[Page 48928-48929]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr26jy02-101]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: 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 filedon selected inventions to extend market coverage for 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. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Suppressing Unencoded MRI Signal Contribution in Multi-Phase Myocardial Tagging and Phase-Contrast Based Methods

Anthony H. Aletras (NHLBI) DHHS Reference No. E-079-02/0 Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: berkleyd@od.nih.gov.

The invention is a method for obtaining clear functional magnetic resonance (MR) cardiac images without significantly increasing signal acquisition time. During functional magnetic resonance imaging (MRI) the specimen magnetization is spatially encoded by application of one or more radio frequency pulses (RF) and gradient magnetic fields. This spatially encoded magnetization is then read out to produce images that can be used to assess specimen motion. During this process the contrast decreases from the beginning of the cardiac cycle as the magnetization decays or relaxes, making the images more difficult to process and interpret over time. This is currently solved by acquiring the images twice (with a modified signal excitation phase) to suppress unwanted unencoded MRI signal contributions; therefore improving the contrast. Unfortunately, this prolongs the acquisition by a factor of two. In the invention, an RF inversion pulse is used to suppress the undesirable unencoded MRI signal contributions, thereby improving the contrast. This RF frequency drives the undesired signal to an equilibrium around zero, while preserving the desired encoded signal. The application of the RF inversion pulse doubles the resolution of the image and does not increase acquisition time. It allows for immediate evaluation of myocardial contractility throughout the whole cardiac cycle without requiring user intervention during phase-based data processing. There is also the possibility that this method could be used in other areas of the body, including the spinal cord, and the invention may be applicable to the study of brain motion. This new method speeds up the quantification of datasets, suppresses undesired signal contributions, and doubles the resolution of the images without doubling acquisition time.

ELISA Assay of Serum Soluble CD22 to Assess Tumor Burden/Relapse in Subjects with Leukemia and Lymphoma

Robert Kreitman et al. (NCI) DHHS Reference No. E-065-02/0 filedMay 20, 2002 Licensing Contact: Richard Rodriguez; 301/496-7056 ext. 287; e-mail: rodrigur@od.nih.gov.

Disclosed are methods of using previously unknown soluble forms of CD22 (sCD22) present in the serum of subjects with B-cell leukemias and lymphomas to assess tumor burden in the subjects. Also disclosed are methods of diagnosing or prognosing development or progression of a B- cell lymphoma or leukemia in a subject, including detecting sCD22 in a body fluid sample taken or derived from the subject, for instance serum. In some embodiments, soluble CD22 levels are quantified. By way of example, the B-cell lymphoma or leukemia can be hairy cell leukemia, chronic lymphocytic leukemia, or non-Hodgkin's lymphoma. Soluble CD22 in some embodiments is detected by a specific binding agent, and optionally, the specific binding agent can be detectably labeled.

Also disclosed are methods of selecting a B-cell lymphoma or leukemia therapy that include detecting an increase or decrease in sCD22 levels in a subject compared to a control, and, if such increase or decrease is identified, selecting a treatment to prevent or reduce B-cell lymphoma or leukemia or to delay the onset of B-cell lymphoma or leukemia.

Other embodiments are kits for measuring a soluble CD22 level, which kits include a specific binding molecule that selectively binds to the CD22, e.g. an antibody or antibody fragment that selectively binds CD22.

Further disclosed methods are methods for screening for a compound useful in treating, reducing, or preventing B-cell lymphomas or leukemias, or development or progression of B-cell lymphomas or leukemias, which methods include determining if application of a test compound lowers soluble CD22 levels in a subject, and selecting a compound that so lowers sCD22 levels.

Mutated Anti-CD22 Antibodies with Increased Affinity to CD22- Expressing Leukemia Cells

Ira Pastan et al. (NCI) HHS Reference No. E-129-01/0 filedSep 26, 2001 Licensing Contact: Richard Rodriguez; 301/496-7056 ext. 287; e-mail: rodrigur@od.nih.gov.

The present invention provides improved antibodies for binding to CD22-expressing cells (CD22 is expressed on B cells and B-cell malignancies), especially cancer cells that express CD22 on their exterior surface. In this regard, the invention provides anti-CD22 antibodies with a variable light (VL) chain having the sequence of antibody RFB4 and a variable heavy (VH) chain having the sequence of antibody RFB4, but in which residues 100, 100A and 100B of CDR3 of said VHchain (as numbered by the Kabat and Wu numbering system)

[[Page 48929]]

have an amino acid sequence selected from the group consisting of: THW, YNW, TTW, and STY. The antibody can be a full length antibody molecule, but is preferably a single chain Fv (``scFv''), a disulfide stabilized Fv (``dsFv''), an Fab, or an F(ab').

The invention further provides compositions comprising these antibodies conjugated or fused to a therapeutic moiety or a detectable label. The therapeutic moiety can be a cytotoxin, a drug, a radioisotope, or a liposome loaded with a drug or a cytotoxin. In preferred embodiments, the effector moiety is a cytotoxin. The cytotoxin can be selected from the group consisting of ricin A, abrin, ribotoxin, ribonuclease, saporin, calicheamycin, diphtheria toxin or a cytotoxic subunit or mutant thereof, a Pseudomonas exotoxin, a cytotoxic portion thereof, a mutated Pseudomonas exotoxin, a cytotoxic portion thereof, and botulinum toxins A through F. In preferred forms, the cytotoxin is a Pseudomonas exotoxin or cytotoxic fragment thereof, or a mutated Pseudomonas exotoxin or a cytotoxic fragment thereof. In particularly preferred forms, the Pseudomonas exotoxin is selected from the group consisting of PE35, PE38, PE38KDEL, PE40, PE4E, and PE38QQR. In the most preferred embodiment, the Pseudomonas exotoxin is PE38. The compositions may further comprise a pharmaceutically acceptable carrier.

Dated: July 19, 2002. Jack Spiegel, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

[FR Doc. 02-18944Filed7-25-02; 8:45 am]

BILLING CODE 4140-01-Py