SPECIAL NOTICE
A -- Notice of Opportunity for Collaboration: TWO MULTI-CENTER CLINICAL TRIALS TO PREVENT RECURRENCE OF HEPATITIS C OR HEPATOCELLULAR CARCINOMA FOLLOWING LIVING DONOR LIVER TRANSPLANTATION
- Notice Date
- 11/30/2010
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W, 6707 Democracy Blvd., MSC 5455, Bethesda, Maryland, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- DK-110054
- Archive Date
- 2/19/2011
- Point of Contact
- Patricia M Lake, Phone: 301-594-6762
- E-Mail Address
-
lakep@mail.nih.gov
(lakep@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice of Opportunity for Collaboration TWO MULTI-CENTER CLINICAL TRIALS TO PREVENT RECURRENCE OF HEPATITIS C OR HEPATOCELLULAR CARCINOMA FOLLOWING LIVING DONOR LIVER TRANSPLANTATION National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) seeks collaborations with industry to provide therapeutic agents for studies to prevent recurrence of hepatitis C (HCV) and recurrence of hepatocellular carcinoma (HCC) among patients undergoing living donor liver transplantation (LDLT). INTRODUCTION: The Adult to Adult Living Donor Liver Transplantation (A2ALL) Cohort Study's overall goal is to determine the outcomes of donors and recipients who choose LDLT (http://www.nih-a2all.org). Work by A2ALL investigators has resulted in a number of peer reviewed publications that serve as standards for the knowledge of LDLT in the United States, among which are papers on the health problems of donors and recipients as a result of transplantation; the survival advantage of LDLT among recipients, recipient mortality and the effect of transplant center experience; recurrence of viral hepatitis C after LDLT compared with deceased donor liver transplantation (DDLT); recurrence of hepatocellular carcinoma following LDLT and DDLT; severe psychiatric problems uncommonly experienced by living donors; resource utilization associated with DDLT and LDLT; and comparison of quality and accuracy of data collected by A2ALL to that of the Scientific Registry of Transplant Recipients. An extension of the study through 2014 will focus on surgical innovations in LDLT, long-term donor outcomes, and prevention of recurrence of HCV and HCC after LDLT. A2ALL is now interested in conducting two additional clinical treatment studies, both among transplant recipients. One study would be to prevent recurrence of HCV through adjuvant treatment prior to or after transplantation. The other study would be to prevent recurrence of HCC through adjuvant treatment prior to or after transplantation, or both. The HCV and HCC studies would be separate and distinct, and patients would be eligible to participate in only one of the two studies. BACKGROUND: Over the last 30 years liver transplantation has become the standard of care and the only cure for end stage liver disease. Its success has led to over 6,000 transplants performed yearly. But about 16,000 patients remain on the transplantation list awaiting deceased liver donation. LDLT constitutes a relatively small (fewer than 5% in 2009) but important portion of all adult liver transplants. Nevertheless, the high mortality and morbidity of patients waiting for transplant continues to put great pressure on consideration of alternatives to deceased liver donation. LDLT remains the main alternative for expanding the number of transplants. It has continued to evolve, with refinement of donor and recipient selection and improvement in outcomes. In response to the challenges surrounding live donor liver transplants, NIDDK established the A2ALL Network in 2002 and refunded it in 2009. The A2ALL Network is currently composed of a data coordinating center and nine clinical transplant centers throughout North America with expertise in the diagnosis, treatment, management, and conduct of clinical trials that have been charged with enrolling approximately 15-30 patients per center per year over a 4 year period. One advantage of LDLT over DDLT is the ability to schedule the transplant procedure well in advance. In contrast, DDLT requires the availability and acceptance of a deceased liver donor offer only a few hours prior to transplantation. For pre- and peri-operative therapies, this advantage of LDLT is critically important. For example, protocols can be developed to provide treatment for a standard period of time that can be stopped at a certain time prior to transplant. For adjuvant therapy to prevent recurrence of disease after transplantation, this ability to time the beginning and cessation of therapy in relationship to transplantation is extremely important. STUDY GOALS: NIDDK through its A2ALL Network is interested in conducting two additional clinical treatment studies. One study would be for the prevention of recurrence of the HCV infection through treatment prior to or after transplantation using pegylated interferon plus ribavirin, in conjunction with HCV direct antiviral agents and/or natural products to determine if such therapy will clear HCV RNA from the blood in HCV-infected recipients and reduce the risk of recurrent HCV and allograft hepatitis. The other study would involve pre-transplant, peri-, and/or post-transplant treatment of HCC using pharmacologic therapies alone or in combination with locoregional ablative therapies to prevent recurrence. SUMMARY: NIDDK is seeking proposals in the form of capability statements from companies that are interested in collaborating with the A2ALL by providing 1) pegylated interferon, ribavirin, HCV direct antiviral agents, natural products with antiviral activity against HCV, and immunotherapy against HCV or 2) chemotherapies, and other pharmacological HCC inhibitors to be used in multi-center clinical studies for adult to adult LDLT. SUPPLEMENTARY INFORMATION: Collaborative arrangements may be either Clinical Trial Agreements or Cooperative Research and Developments Agreements (CRADAs) pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 U.S.C. 3710; and Executive Order 12591 of April 10, 1987, as amended by the National Technology Transfer and Advancement Act of 1995), as appropriate. Clinical Trial Agreements and CRADAs are agreements designed to enable certain collaborations between Government laboratories and non-Government laboratories. They are not grants, and not contracts for the procurement of goods/services. The NIDDK is prohibited from transferring funds to a Clinical Trial or CRADA collaborator. Under a CRADA, NIDDK can contribute facilities, staff, materials, and expertise to the effort. The collaborator typically contributes facilities, staff, materials, expertise, and funding to the collaboration. The CRADA collaborator receives an exclusive option to negotiate an exclusive or non-exclusive license to Government intellectual property rights arising under the CRADA in a pre-determined field of use and make contributions that qualify one or more of its employees as a co-inventor(s) of new technology developed under the CRADA. CAPABILITY STATEMENTS: The NIDDK will utilize the information provided in the Collaborator Capability Statements received in response to this announcement to help in development of trials to prevent recurrence of HCV and HCC following LDLT. It is the intention of the NIDDK that all qualified Collaborators have the opportunity to provide information through their capability statements. A company may respond with capability statements for both studies. If a company wishes to respond to both the HCV and HCC opportunities, then separate and distinct Capability Statements are required. The Capability Statement should not exceed 12 pages of narrative and should address the criteria below. If necessary, supportive data should be provided as an attachment to the Capability Statement. 1. The proposed preparation must have been tested in clinical trials among patients with compensated cirrhosis or with more advanced liver disease. 2. The statement should provide specific details of the methods to be utilized in the investigation of therapeutic agents including drugs, and biologics in patients with HCV or HCC and clearly describe important issues surrounding the evaluation of disease management in these patients. 3. For HCV, the statement should include a detailed plan demonstrating the ability to provide central testing of HCV RNA for the duration of the study. 4. For HCC, the statement should indicate the Company's plans and/or capabilities for central radiological review to assess tumor stage and response. 5. For both HCV and HCC, the statement should provide a description of laboratory tests that are needed including assays and required amount of specimens, to determine specific biomarker levels along with appropriate methods for performing. 6. The statement may include outcome measures of interest to the Collaborator. The specifics of the proposed outcome measures and the proposed support should include but not be limited to treatment and evaluation of hepatitis C or hepatocellular carcinoma, personnel, services, facilities, equipment, or other resources that would contribute to the conduct of the commercial development. 7. If appropriate, specific funding commitment to support the advancement of scientific research. 8. The Collaborator must agree to have its preparation used in the above-mentioned A2ALL Network-developed protocols and will have data collection and analysis performed by the A2ALL Network's Data Coordinating Center. 9. The Collaborator's willingness for NIDDK to serve as the regulatory sponsor of the studies, filing the IND applications with the FDA. 10. The Collaborator must provide the NIDDK, as IND sponsor of the studies, with cross-reference access to a US FDA filing that contains the chemistry, manufacturing and controls information for the drug substance and drug product. 11. Dosing and Pharmacokinetic data from human studies must be provided for novel agents. 11. Adverse event profile from human studies must be provided. 12. Must agree to share with NIDDK and potentially the A2ALL Network all safety data from other studies involving their preparation as well as relevant efficacy data from other studies (updated Investigator Brochure, etc). 13. A plan for drug distribution should be discussed. 14. Assistance in the analysis of adverse events and serious adverse events is required. 15. The statement must address willingness to promptly publish research results. SUBMISSION DATES: Only written capability statements received by the NIDDK on or before February 4, will be considered. Applicants meeting the criteria as set forth in this announcement will be invited at the Applicants own expense to discuss with the A2ALL Network Steering Committee their plans, capabilities, and research findings pertinent to the proposed studies at a meeting of the A2ALL Research Network Steering Committee to be held during the first half of March 2011 in the San Francisco Bay area. CONTACT INFORMATION: Submit Capability Statements to: Patricia Mello Lake Deputy Director, Extramural Technology Transfer National Institute of Diabetes and Digestive and Kidney Diseases 12 South Drive Suite 3011, MSC 5632 Bethesda, MD 20892-5632 Phone: (301) 594-6762 Fax: (301) 480-7546 e-mail: lakep@mail.nih.gov For Scientific Inquiries contact: James (Jay) Everhart, M.D., M.P.H. Project Officer, A2ALL Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases, NIH 6707 Democracy Blvd., Room 655 Bethesda, MD 20892-5458 Phone: 301.594.8878 e-mail: everhartj@mail.nih.gov
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