[Federal Register Volume 64, Number 118 (Monday, June 21, 1999)] [Notices] [Pages 33102-33103] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-15638] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases: Licensing Opportunity and/or Cooperative Research and Development Agreement (``CRADA'') Opportunity; Drug and Method for the Therapeutic Treatment of Respiratory Syncytial Virus and Parainfluenza Virus in Children AGENCY: National Institutes of Health, Public Health Service, DHHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The National Institute of Allergy and Infectious Diseases (NIAID) of the NIH is seeking Licensees and/or capability statements from parties to further develop, evaluate, and commercialize eosinophil-derived neutralizing agent (EDNA) for the treatment of infections in children and/or the elderly caused by Respiratory Syncytial Virus (RSV) and parainfluenza virus (PIV). RSV and PIV are medically the most important single-stranded RNA viruses; infections caused by these viruses hospitalize over 100,000 infants per year in the U.S. The methods and compositions of this invention provide a means for prevention and treatment of infection by enveloped RNA viruses by eoxinophil derived neutralizing agent (EDNA), a ribonuclease. EDNA is a relatively soluble and thermostable protein, active at low concentrations, with no direct toxicity to bronchial epithelial cells, making it suitable for inhalation therapy. Parenteral administration is also contemplated by this invention. EDNA, particularly recombinant EDNA, may be used as an agent for direct inhalation therapy in children with established RSV bronchiolitis (associated with the development of future respiratory disorders such as asthma), in children for which there is a high index of suspicion, and as prophylactic therapy in children with predisposing conditions such as prematurity, bronchiole pulmonary displasia, congential heart disease and immunodeficiency. Similar criteria may be applied to the susceptible elderly population. Recombinant human EDNA has been produced in bacterial and baculovirus expression systems. Furthermore, in vitro experiments have shown it to have potent antiviral activity against RSV (Domachowske, JB et al., 1998, J. Infect. Dis. 177:1458-1464.) Initial studies in the Balb/C mouse model of RSV infection support its effectiveness against this virus. This project is a part of the study of ribonucleases and host defenses in the Laboratory of Host Defenses (LHD), Division of Intramural Research, NIAID. The invention claimed in DHHS Reference No. E-161-97/1, ``Methods for Inactivating Enveloped RNA Virus Particles and Compositions for Use Therewith'' (HF Rosenberg, JB Domachowske), PCT/US98/13852 filed July 2, 1998, is available for exclusive or non-exclusive licensing in accordance with 35 U.S.C. 207 and 37 CFR part 404 and/or further development under one or more CRADAs in the clinically important applications described below in the Supplementary Information section. ADDRESSES: Questions about licensing opportunities should be addressed to Peter Soukas, J.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804, Telephone: (301) 496-7056 ext. 268; Facsimile: (301) 402-0220; E-mail: [email protected]. Information about Patent Applications and pertinent information not yet publicly described can be obtained under the terms of a [[Page 33103]] Confidential Disclosure Agreement. Respondents interested in licensing the invention will be required to submit an ``Application for License to Public Health Service Inventions.'' Depending upon the mutual interests of the Licensee(s) and the NIAID, a CRADA to collaborate to develop EDNA as an anti-RSV therapeutic may also be negotiated. Proposals and questions about this CRADA opportunity should be addressed to Dr. Michael R. Mowatt, Technology Development Manager, Office of Technology Development, NIAID, Building 31, Room 3B62, 31 Center Drive, Bethesda, MD 20892- 2137, Telephone: (301) 435-8618; E-mail: [email protected]. Respondents interested in submitting a CRADA Proposal should be aware that it may be necessary to secure a license to the above-mentioned patent rights in order to commercialize products arising from a CRADA. EFFECTIVE DATE: Respondents interested in licensing the invention will be required to submit an ``Application for License to Public Health Service Inventions'' on or before September 20, 1999, for priority consideration. Interested CRADA collaborators must submit a confidential proposal summary to the NIAID [attention Dr. Michael Mowatt at the aforementioned address' on or before September 20, 1999, for consideration. Guidelines for preparing full CRADA proposals will be communicated shortly thereafter to all respondents with whom initial confidential discussions will have established sufficient mutual interest. CRADA and PHS License Applications submitted thereafter may be considered if a suitable CRADA collaborator of Licensee(s) has not been selected. SUPPLEMENTARY INFORMATION: Under the CRADA the production of biologically active recombinant human EDNA will be optimized and the agent evaluated in a series of preclinical studies in animals as well as initial safety testing in humans. Positive outcomes of these studies will indicate continued clinical development aimed at supporting regulatory approval of a product to be labeled for use in children and/ or the elderly. The Public Health Service (PHS) has filed patent applications both in the U.S. and internationally related to this technology. Notice of the availability of the patent application for licensing was first published in the Federal Register (Vol. 62, No. 219, Page 60909) on November 13, 1997 NIAID's principal investigator has extensive experience with recombinant technology as applied to ribonucleases, their purification and testing. The Collaborator in this endeavor is expected to assist NIAID in evaluating its current system for producing recombinant EDNA and to develop and optimize an alternative expression system, if necessary, to manufacture sufficient quantities of the product for preclinical testing in animals and initial safety studies in humans. The Collaborator must have experience in the manufacture of recombinant protein products according to applicable FDA guidelines and Points to Consider documents to include Good Manufacturing Procedures (GMP). In addition, it is expected that the Collaborator would provide funds to supplement the LHD's research budget for the project and to support the preclinical and initial human testing. The capability statement should include detailed descriptions of: (1) Collaborator's expertise in the expression of recombinant proteins, (2) Collaborator's ability to manufacture sufficient quantities of the product according to FDA guidelines and Points to Consider documents, (3) the technical expertise of the Collaborator's principal investigator and laboratory group in preclinical safety testing (e.g., expertise in in vitro and in vivo toxicity and pharmacology studies) and initial human safety studies, and (4) Collaborator's ability to provide adequate funding to support preclinical and initial human safety studies required for marketing approval. Dated: May 24, 1999. Mark Rohrbaugh, Director, Office of Technology Development, National Institute of Allergy and Infectious Diseases. Dated: June 10, 1999. Jack Spiegel, Director, Division of Technology Development and Transfer, Office of Technology Transfer. [FR Doc. 99-15638 Filed 6-18-99; 8:45 am] BILLING CODE 4140-01-M