Prospective Grant of Exclusive License: Method To Treat Psoriasis in Humans, 23263-23264 [E8-9254]

Download as PDF Federal Register / Vol. 73, No. 83 / Tuesday, April 29, 2008 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Development of Cancer Therapeutics in Humans National Institutes of Health, Public Health Service, HHS. ACTION: Notice. sroberts on PROD1PC70 with NOTICES AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in PCT Application Serial No. PCT/US07/083027 and foreign equivalents thereof, entitled ‘‘Smoothened Polypeptides and Methods of Use’’ [HHS Ref. No. E–014– 2007/0]; PCT Application Serial No. PCT/US07/083772 and foreign equivalents thereof, entitled ‘‘SelfAssembling Nanoparticles Composed of Transmembrane Peptides and Their Application for Specific Intra-Tumor Delivery of Anti-Cancer Drugs’’ [HHS Ref. No: E–256–2006/0]; and U.S. Patent No. 7,105,488, and foreign equivalents thereof, entitled ‘‘G Protein-Coupled Receptor Antagonists’’ [HHS Ref. No: E– 290–1997/0] to Calidris Therapeutics which is registered in Japan. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive licensed territory may be worldwide and the field of use may be limited to peptidomimetic drugs for the treatment of cancer as claimed in the Licensed Patent Rights. These cancers may be limited to multiple myeloma, colon, lung, melanoma, liver, breast, prostate, ovarian, pancreatic cancers, ALL, AML, NHL, rhabdomyosarcoma, neuroblastoma, osteosarcoma and medulloblastoma. With respect to the GPCR technology, the exclusive license field of use may be limited to antagonists of the GPCR CXCR4. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before June 30, 2008, will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Jennifer Wong, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive VerDate Aug<31>2005 21:01 Apr 28, 2008 Jkt 214001 Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 4633; Facsimile: (301) 402–0220; E-mail: wongje@mail.nih.gov. SUPPLEMENTARY INFORMATION: The first technology describes inhibitors Smoothened protein (SMO), a receptor involved in the Hedgehog/Patched (HH/ PTCH) pathway. HH/PTCH is a common pathway involved in proliferative disorders including cancer and psoriasis. The technology is directed towards several synthetic peptides (including all-D analogs) corresponding to specific region of the SMO protein. Experiments in vitro demonstrate that they potentially suppress the growth of cancer cells and inhibit the expression of the HH/PTCH pathway genes. Due to their high hydrophobic properties, these peptide inhibitors can be easily formulated for specific intratumor delivery or topical creams for skin disorders. The second technology relates to peptides corresponding to transmembrane domains of a number of integral membrane proteins. These peptides spontaneously self-assemble in aqueous solutions into stable and remarkably uniform nanoparticles. The nanoparticles of the current invention are fully synthetic, and their surfaces can be engineered to provide specific binding to cell surface receptors overexpressed on tumor cells. Thus, they are even more specific for tumor targeting. Nanoparticles constructed from transmembrane domains of certain receptors and transporters have biological activities of their own and inhibit metastasis or drug resistance thus sensitizing tumors to therapy. Hydrophobic drugs can be easily entrapped inside the nanoparticles, which not only solve the problem of drug insolubility under physiological conditions, but also generate a form of a drug that concentrates in tumors due to enhanced permeability and retention effects. The third technology relates to GPCRs. GPCRs are a large family of transmembrane receptors involved in the regulation of physiological activities. The inventors have found that if a peptide consisting of one of the GPCR transmembrane regions has a charged amino acid on the extracellular side and if said peptide is brought into contact with a cell with same GPCR, the GPCR function is disrupted. The inventors have developed inhibitory GPCR CXCR4 peptides. CXCR4 plays a significant role in cancer development as it is involved in tumor cell proliferation, migration, and metastasis. PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 23263 The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless within sixty (60) days from the date of this published notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. April 21, 2008. David Sadowski, Deputy Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8–9286 Filed 4–28–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Method To Treat Psoriasis in Humans National Institutes of Health, Public Health Service, HHS. AGENCY: ACTION: Notice. SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/855,422 and PCT Application Serial No. PCT/US07/ 083027 and foreign equivalents thereof, entitled ‘‘Smoothened Polypeptides and Methods of Use’’ [HHS Ref. No. E–014– 2007/0], to Lee’s Pharmaceuticals, Ltd., which is located in Hong Kong, China. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive licensed territory may be Asia and the field of use may be limited to the use of Licensee’s proprietary delivery formulation for the treatment of E:\FR\FM\29APN1.SGM 29APN1 23264 Federal Register / Vol. 73, No. 83 / Tuesday, April 29, 2008 / Notices Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before June 30, 2008 will be considered. Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Jennifer Wong, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 4633; Facsimile: (301) 402–0220; E-mail: wongje@mail.nih.gov. Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: April 21, 2008. David Sadowski, Deputy Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8–9254 Filed 4–28–08; 8:45 am] psoriasis as claimed in the Licensed Patent Rights. DATES: ADDRESSES: The technology describes inhibitors Smoothened protein (SMO), a receptor involved in the Hedgehog/Patched (HH/ PTCH) pathway. HH/PTCH is a common pathway involved in proliferative disorders including cancer and psoriasis. The technology is directed towards several synthetic peptides (including all-D analogs) corresponding to specific region of the SMO protein. Experiments in vitro demonstrate that they potentially suppress the growth of cancer cells and inhibit the expression of the HH/PTCH pathway genes. Due to their high hydrophobic properties, these peptide inhibitors can be easily formulated for specific intratumor delivery or topical creams for skin disorders. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR Part 404.7. The prospective exclusive license may be granted unless within sixty (60) days from the date of this published notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. SUPPLEMENTARY INFORMATION: See ‘‘Public Solicitation of New Information’’ section for instructions on how to submit information. ADDRESSES: For species-specific information, contact the appropriate individual named in the ‘‘Public Solicitation of New Information’’ section, below. Individuals who are hearing impaired or speech impaired may call the Federal Relay Service at (800) 877–8337 for TTY assistance. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Why Are 5-Year Reviews Conducted? BILLING CODE 4140–01–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS–R1–ES–2008–N0047; 10120–1113– 0000–C4] Endangered and Threatened Wildlife and Plants: Initiation of 5-Year Status Reviews for 70 Species in Idaho, Montana, Oregon, Washington, and the Pacific Islands Fish and Wildlife Service, Interior. ACTION: Notice of review. AGENCY: SUMMARY: We, the U.S. Fish and Wildlife Service, initiate 5-year status reviews for 70 species in Idaho, Montana, Oregon, Washington, and the Pacific Islands under the Endangered Species Act of 1973, as amended (Act). We request any new information on these species that may have a bearing on their classification as endangered or threatened. Based on the results of these 5-year reviews, we will determine whether these species are properly classified under the Act. DATES: We must receive your information no later than June 30, 2008. However, we will continue to accept new information about any listed species at any time. Under the Endangered Species Act (Act) (16 U.S.C. 1531 et seq.), we maintain a List of Endangered and Threatened Wildlife and Plants (List) at 50 CFR 17.11 (for animals) and 17.12 (for plants). Section 4(c)(2)(A) of the Act requires that we conduct a review of listed species at least once every 5 years. Then, on the basis of such reviews under section 4(c)(2)(B), we determine whether or not any species should be removed from the List (delisted), or reclassified from endangered to threatened or from threatened to endangered. These actions must be supported by the best scientific and commercial data available. Delisting a species is considered only if such data substantiates that the species is neither endangered nor threatened for one or more of the following reasons: (1) The species is extinct; (2) the species is recovered; and/or (3) the original data available when the species was listed, or the interpretation of such data, were in error (50 CFR 424.11(d)). Any change in Federal classification would require a separate rulemaking process (i.e., a proposed rule, public comment period, and final rule). Regulations at 50 CFR 424.21 require that we publish a notice in the Federal Register announcing those species under active review. This notice announces our active review of the 70 species listed in Table 1. TABLE 1.—SPECIES FOR WHICH WE ARE INITIATING A STATUS REVIEW TO DETERMINE IF THEY ARE APPROPRIATELY LISTED UNDER THE U.S. ENDANGERED SPECIES ACT Common name Scientific name Status Current range Final listing rule sroberts on PROD1PC70 with NOTICES ANIMALS Akepa, Hawaii (honeycreeper) Akiapola‘au (honeycreeper) ...... Coot, Hawaiian ......................... Creeper, Hawaii ........................ Megapode, Micronesian ........... Millerbird, Nihoa (old world warbler). VerDate Aug<31>2005 21:59 Apr 28, 2008 Loxops coccineus coccineus .... Hemignathus munroi ................ Fulica americana alai ............... Oreomystis mana ..................... Megapodius laperouse ............. Acrocephalus familiaris kingi .... Jkt 214001 PO 00000 Frm 00087 Endangered Endangered Endangered Endangered Endangered Endangered Fmt 4703 Sfmt 4703 U.S.A. U.S.A. U.S.A. U.S.A. U.S.A. U.S.A. (HI) ................................ (HI) ................................ (HI) ................................ (HI) ................................ (MP), Palau ................... (HI) ................................ E:\FR\FM\29APN1.SGM 29APN1 35 32 35 40 35 32 FR FR FR FR FR FR 16047; 10/13/1970 4001; 03/11/1967 16047; 10/13/1970 44149; 10/28/1975 8491; 06/02/1970 4001; 03/11/1967

Agencies

[Federal Register Volume 73, Number 83 (Tuesday, April 29, 2008)]
[Notices]
[Pages 23263-23264]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9254]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Method To Treat Psoriasis 
in Humans

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive patent license to practice the inventions embodied in U.S. 
Provisional Patent Application No. 60/855,422 and PCT Application 
Serial No. PCT/US07/083027 and foreign equivalents thereof, entitled 
``Smoothened Polypeptides and Methods of Use'' [HHS Ref. No. E-014-
2007/0], to Lee's Pharmaceuticals, Ltd., which is located in Hong Kong, 
China. The patent rights in these inventions have been assigned to the 
United States of America.
    The prospective exclusive licensed territory may be Asia and the 
field of use may be limited to the use of Licensee's proprietary 
delivery formulation for the treatment of

[[Page 23264]]

psoriasis as claimed in the Licensed Patent Rights.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before June 
30, 2008 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Jennifer Wong, Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 435-4633; Facsimile: (301) 402-0220; E-mail: 
wongje@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The technology describes inhibitors 
Smoothened protein (SMO), a receptor involved in the Hedgehog/Patched 
(HH/PTCH) pathway. HH/PTCH is a common pathway involved in 
proliferative disorders including cancer and psoriasis.
    The technology is directed towards several synthetic peptides 
(including all-D analogs) corresponding to specific region of the SMO 
protein. Experiments in vitro demonstrate that they potentially 
suppress the growth of cancer cells and inhibit the expression of the 
HH/PTCH pathway genes. Due to their high hydrophobic properties, these 
peptide inhibitors can be easily formulated for specific intratumor 
delivery or topical creams for skin disorders.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR Part 
404.7. The prospective exclusive license may be granted unless within 
sixty (60) days from the date of this published notice, the NIH 
receives written evidence and argument that establishes that the grant 
of the license would not be consistent with the requirements of 35 
U.S.C. 209 and 37 CFR 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted to 
this notice will not be made available for public inspection and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: April 21, 2008.
David Sadowski,
Deputy Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
 [FR Doc. E8-9254 Filed 4-28-08; 8:45 am]
BILLING CODE 4140-01-P

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