SPECIAL NOTICE
A -- TYPE 1 DIABETES (T1D) CLINICAL TRIAL OF THE EFFECTS OF ANTI-CD3 & EXENATIDE ON LOSS OF INSULIN PRODUCTION IN PATIENTS WITH RECENT ONSET T1D AND INDIVIDUALS AT HIGH RISK
- Notice Date
- 4/11/2006
- Notice Type
- Special Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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, MD, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- Reference-Number-DK06-0385
- Response Due
- 6/1/2006
- Archive Date
- 6/16/2006
- Description
- Notice of Opportunity for Collaboration TYPE 1 DIABETES TRIALNET MULTI-CENTER CLINICAL TRIAL OF THE EFFECTS OF ANTI-CD3 AND EXENATIDE ON LOSS OF INSULIN PRODUCTION IN PATIENTS WITH RECENT ONSET TYPE 1 DIABETES AND IN INDIVIDUALS AT HIGH RISK FOR THE DEVELOPMENT OF TYPE 1 DIABETES The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) of the Public Health Service (PHS) of the Department of Health and Human Services (DHHS) seeks collaborations with Industry to provide anti-CD3 for use in a NIH-sponsored multi-center trial to evaluate the effects of anti-CD3 and exenatide on the loss of insulin production in patients with recent onset type 1 diabetes mellitus (T1DM) and in individuals at high-risk for the development of T1DM. INTRODUCTION: The TrialNet anti-CD3 plus exenatide study will evaluate the effects of this combination of agents on preservation of insulin production in patients with new-onset T1DM and in individuals at high-risk for the development of T1DM. The combination of these two treatment approaches may inhibit the autoimmune response responsible for beta cell destruction (anti-CD3) while improving beta cell mass (Exenatide). Unlike the currently approved treatments of T1DM which involve replacement of insulin, the combination of these two agents may have a significant and lasting impact on the natural history and clinical course of T1DM in which the primary pathologic abnormality is destruction of insulin producing Beta cells. TrialNet hypothesizes that the combination of an immune tolerizing therapy with one that may improve beta cell mass will result in substantial clinical benefit for subjects with or at high-risk for T1DM. The initial TrialNet anti-CD3 plus exenatide trial will include patients with new-onset T1DM and consists of a safety pilot phase followed by a full-scale study. The safety pilot phase is being performed to assess the safety and feasibility of anti-CD3 plus exenatide for the treatment of individuals with new-onset type 1 diabetes. It is a 2-arm, multi-center, randomized, open-labeled, controlled clinical trial. Thirty patients will be recruited over a 6-month period to receive either intervention or control treatment. The intervention group will receive a 14-day course of anti-CD3 combined with one year of exenatide administration and intensive diabetes management. The control group will receive intensive diabetes management alone. The full-scale study will assess the safety, efficacy, and mode of action of anti-CD3 plus exenatide for preservation of residual insulin production in patients with new-onset type 1 diabetes. This 4-arm, multi-center, randomized, open-labeled, controlled clinical trial will enroll 130 additional participants over a 2-year period. In the full-scale study, subjects will be randomized to receive either anti-CD3 alone, exenatide alone, a combination of anti-CD3 plus exenatide, or intensive diabetes management alone. Both phases will include participants 8*-45 years of age (*once sufficient data has been obtained on older participants). They must have at least one diabetes-associated autoantibody and must have been diagnosed within T1DM for less than or equal to 3 months. An additional study using the same treatment regimen will be initiated in individuals at high-risk for the development of T1DM sometime during the full-scale study in new-onset T1DM patients. STUDY GOALS: The goal of the pilot study is to determine whether treatment of new-onset T1DM with anti-CD3 plus exenatide is feasible and has an acceptable adverse event profile. The primary goal of the full-scale study is to compare beta cell function (stimulated C-peptide response) in the treatment versus control groups. The subsequent trial, which will be performed in high-risk individuals, will assess time to development of T1DM. REQUIREMENTS FOR SELECTION: Potential Industry Collaborators must meet the following criteria: 1. Must agree to have their anti-CD3 preparation used in the above-mentioned TrialNet-developed protocols which will be conducted by TrialNet and will have data collection and analysis performed by the TrialNet Coordinating Center (TNCC). 2. Must be able to assure TrialNet that sufficient anti-CD3 will be made available to complete the proposed TrialNet studies, even if development of the anti-CD3 is voluntarily interrupted or halted (this would not apply in the event of a safety issue that leads to termination of the program under the guidance of the FDA). 3. Must agree to provide anti-CD3 supplies according to a mutually agreed upon schedule. 4. Must provide Certificates of Analysis, product labeling, stability dating and storage conditions for each lot of anti-CD3 to be used in the TrialNet study. 5. Must be prepared to supply their anti-CD3 preparation for immediate use in the TrialNet new-onset T1DM trial and subsequently for use in the T1DM trial in individuals at high-risk for the development of T1DM. 6. Must provide IND sponsor of the TrialNet study with cross-reference access to a US FDA filing that contains the chemistry, manufacturing and controls information for the anti-CD3 drug substance and drug product. 7. The proposed anti-CD3 preparation must have been tested in Phase I trials in humans. 8. Dosing and Pharmacokinetic data from human studies must be provided. 9. Adverse event profile from human studies must be provided. 10. Must agree to share (with TrialNet) all safety data from other studies involving their anti-CD3 preparation as well as relevant efficacy data from other studies (updated Investigator Brochure, etc). 11. Must agree to have their anti-CD3 preparation used in conjunction with exenatide, the other study agent. 12. If monitoring is required by the Collaborator so that the data conform to FDA requirements for a New Drug Application (NDA), Collaborator must agree to have such clinical site monitoring coordinated by the TNCC, and must agree to pay for such monitoring. Potential Collaborators should submit a brief capability statement to the contact person noted below. CAPABILITY STATEMENT: A Selection Committee will utilize the information provided in the "Collaborator Capability Statements" received in response to this announcement to help in its deliberations. It is the intention of the NIDDK that all qualified Collaborators have the opportunity to provide information to the Selection Committee through their capability statements. The Capability Statement should not exceed three (3) pages of narrative (not including appendices) and should address all selection criteria (for the particular anti-CD3 preparation being proposed) in addition to the following items: (1) name of agent; (2) stage of clinical investigation with the anti-CD3 agent, including whether phase I, IIa, IIb, and III trials are completed or underway and the number of subjects and dose administered in each; (3) dosing data in humans; (4) adverse event profile in humans; (5) willingness to have the agent used in combination with another agent, exenatide. 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. SUBMISSION DATES: Only written capability statements received by the NIDDK on or before June 1, 2006 will be considered. CONTACT INFORMATION: Capability Statements should be submitted to: Patricia M. Lake Deputy Director, Extramural Technology Transfer Office of Technology Transfer and Development National Institute of Diabetes and Digestive and Kidney Diseases, NIH 6707 Democracy Boulevard, Room 906B Bethesda, MD 20892 Phone: (301) 594-6762 Fax: (301) 480-7546 E-mail: lakep@mail.nih.gov For Scientific Inquiries contact: Ellen Leschek, M.D. Program Director, Type 1 Diabetes TrialNet Division of Diabetes, Endocrinology, and Metabolism National Institute of Diabetes and Digestive and Kidney Diseases, NIH 6707 Democracy Boulevard, Room 603 Bethesda, MD 20892 Phone: (301) 402-8291 Fax: (301) 480-3503 E-mail: LeschekE@extra.niddk.nih.gov
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