[Federal Register Volume 64, Number 193 (Wednesday, October 6, 1999)] [Notices] [Page 54336] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-25950] ----------------------------------------------------------------------- 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 invention listed below is owned by an agency of the U.S. Government and is 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. ADDRESSES: Licensing information and a copy of the U.S. patent application referenced below may be obtained by contacting J.R. Dixon, Ph.D., at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852- 3804 (telephone 301/496-7056, ext. 206; fax 301/402-0220; E-Mail: [email protected]). A signed Confidential Disclosure Agreement is required to receive a copy of any patent application. SUPPLEMENTARY INFORMATION: Title: ``Diagnostic and Therapeutic Methods of Detecting and Treating Cancers of Reproductive Tissues.'' Inventors: Drs. Ira H. Pastan (NCI), Ulrich Brinkmann (NCI), George Vasmatzis (NCI) and Byungkook Lee (NCI). DHHS Ref. No. E-028-99/0--Filed with the U.S.P.T.O. September 1, 1998. Background The basis of cancer immunotherapy as a viable option of treatment rests on the supposition that tumor-specific antigens are expressed by the tumor cells, and that immune effector mechanisms can be induced selectively to destroy these tumor cells. Although a variety of host immune effector cells have been shown to participate in the killing of tumor cells, tumor-specific CD8+ Cytotoxic T Lymphocytes (``CTL'') are highly specific and effective in mediating tumor cell killing. CTLs that recognize tumor cells have been isolated from melanoma, breast, ovarian, renal, lung, colorectal and prostrate cancer patients. Their existence suggests that there is an immune response to cancer in these patients and that its augmentation might be therapeutically beneficial. Thus, approaches based on induction of tumor-specific CTLs by therapeutic vaccines may provide an attractive alternative for treating cancer patients. Technology PAGE-4 is a human X-linked gene that is strongly expressed in prostate and prostate cancer, and is also expressed in other male and female reproductive tissue (e.g., testis, fallopian tube, placenta, uterus, and uterine cancer). PAGE-4 shows similarity with the GAGE protein family, but it diverges significantly from members of the family so that it appears to belong to a separate family. This, and the existence of another gene, PAGE-2, that share more homology with PAGE-4 than with members of the GAGE family indicates that the PAGE-4 protein belongs to a separate protein family. The specific detection of PAGE-4 might be valuable for the diagnosis of prostate and testicular tumors, as well as uterine tumors. There are sufficient differences between PAGE-4 and other members of the PAGE and MAGE proteins to produce specific antibodies. Analyses with such antibodies are needed to confirm by immunohistology the expression specificity that is seen in database and mRNA analyses, and to evaluate whether anti-PAGE-4 immunotherapy could be a promising therapeutic approach. One possibility of eliminating PAGE-4 expressing cells could be to use it as cancer vaccine. Among the many possible approaches to vaccination, one method is direct vaccination with plasmid DNA. In fact, Dr. Pastan's laboratory has been able to obtain good expression of the PAGE-4 protein with mammalian expression plasmids, and has demonstrated that DNA-immunization with such expression constructs leads to good immune responses. Hence, this method may generate anti-PAGE-4 responses, and allow us to analyze if ``PAGE-4-vaccination'' can eliminate PAGE-4 expressing cells, as a therapeutic approach towards neoplasms of the prostate, testis, and uterus. Prostate Cancer Prostate Cancer is a disease affecting approximately 1 million men in the U.S.A., with an annual incidence of around 300,000 and approximately 40,000 deaths per year. Control of primary tumor by surgical resection and/or radiation has proven effective in a number of cases, however, metastatic spread, primarily to the bone, especially at late hormone independent stages of the disease, has been more difficult to control and monitor. The above mentioned invention is available, including any available foreign intellectual property rights, for licensing on an exclusive or non-exclusive basis. Dated: September 28, 1999. Jack Spiegel, Ph.D., Director, Division of Technology Development & Transfer, Office of Technology Transfer. [FR Doc. 99-25950 Filed 10-5-99; 8:45 am] BILLING CODE 4140-01-M