SPECIAL NOTICE
A -- OPPORTUNITY FOR CLINICAL TRIAL AGREEMENT (CTA): Clinical trials of Saw Palmetto for Benign Prostatic Hypertrophy
- Notice Date
- 4/4/2006
- 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, National Cancer Institute, Bldg 427, Room 12, Frederick, MD, 21702
- ZIP Code
- 21702
- Solicitation Number
- Reference-Number-CM-01
- Response Due
- 8/1/2006
- Archive Date
- 8/2/2006
- Description
- INTRODUCTION: NIDDK, NCCAM, and ODS will evaluate in a phase I / II trial, and potentially develop via a phase III trial, Saw Palmetto for Benign Prostatic Hypertrophy (BPH). NCCAM will file an IND with the FDA for this purpose. SUMMARY: The National Center for Complementary and Alternative Medicine (NCCAM), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , and the Office of Dietary Supplements (ODS) of the National Institutes of Health (NIH), U.S Department of Health and Human Services, is seeking proposals in the form of capability statements from companies for a Clinical Trial Agreement (CTA) to provide Saw Palmetto to support the NIH?s Saw Palmetto clinical trials program. The saw palmetto product must be presently available in the United States. The initial part of the Saw Palmetto clinical trials program consists of a phase 1 / 2 dose-ranging study. The protocol for the phase I / II clinical trial has been written by a Saw Palmetto Steering Committee (SC) consisting of an Invited Chair, Principal Investigators from 11 clinical centers, and the Principal Investigator of the Data Coordinating Center. The protocol and SC membership are attached. The protocol is designed as a dose-escalation study for the active (and placebo) groups. Because the Product has not yet been chosen, the present protocol cannot include exact doses. The intent, however, is that the initial dose will be the customary dose; the final dose will be the maximum amount of product that can feasibly be administered for a period of months; the middle dose will be between the initial dose and the final dose. It is likely that these doses will be 1 pill (initial dose), 2 pills (middle dose), 3 pills (final dose). It is possible that other protocol particulars might need to be modified to be in conformity with Product characteristics. However, NIH foresees that only minor protocol alterations will be necessary after the Product has been chosen. If the data from the phase 1 / 2 trials suggests that proceeding to phase 3 is appropriate, NIH, SC, and Product Supplier/Collaborator will together plan a phase 3 pivotal trial. 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), the National Center For Complementary and Alternative Medicine of the National Institutes of Health (NIH) of the Public Health Service (PHS) of the Department of Health and Human Services (DHHS) seeks a Clinical Trial Agreement (CTA) with a suitable company to provide Saw Palmetto to support these clinical studies for benign prostatic hypertrophy. The potential Collaborator?s capability statement should provide proof of A) product quality, B) non-clinical safety and efficacy, C) clinical safety and efficacy, D) ability to meet regulatory requirements, and E) ability to provide product for the phase I / II trial and potentially the phase III trial. More detailed criteria that the Collaborator?s capability statement should address are listed under ?capability statement? at the end of this document. Collaborator will be a non-voting member of the Saw Palmetto Steering Committee. DATES: Only written CTA capability statements received by the NCCAM on or before Aug 1, 2006 will be considered. The capability statements will be reviewed by a Scientific Review Panel. Applicants meeting the criteria as set forth in this announcement may be invited at the Applicants? own expense to discuss with the NCCAM further aspects of product dossier at a date to be determined. FOR ADDITIONAL INFORMATION AND QUESTIONS: Capability statements should be submitted to Charlotte McGuinness, Technology Transfer Specialist, Technology Transfer Branch, National Cancer Institute, 6120 Executive Blvd. Suite 450, Rockville, MD 20852; tel: 301-496-0477, email: mcguinnc@mail.nih.gov. For technical questions, please contact Jonathan (Josh) Berman MD PhD, Director, Office of Clinical and Regulatory Affairs, National Center For Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Blvd, Suite 401, Bethesda MD 20892 USA, Tel: 301-594-7105, Email: Bermanjo@mail.nih.gov. SUPPLEMENTARY INFORMATION: A CTA is an agreement designed to enable certain collaborations between Government laboratories and non-Government laboratories. It is not a grant, and is not a contract for the procurement of goods/services. The NCCAM is prohibited from transferring funds to a CTA collaborator. Under a CTA, NCCAM can contribute facilities, staff, materials, and expertise to the effort. The collaborator typically contributes facilities, staff, materials, and expertise to the collaboration. Typically, the data generated as a result of this collaboration is the property of the Government laboratories, but Collaborator will have right of access to and use of the data for regulatory purposes. Capability Statements: 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 NCCAM that all qualified Collaborators have the opportunity to provide information to the Selection Committee through their capability statements. The Capability Statement must address the following selection criteria: A. CMC CRITERIA General: The details should be in conformity with FDA?s expert advice with respect to acceptability for a pivotal trial. See for reference: ?Botanical Drug Products ? Guidance for Industry CDER, FDA. June 2004. In particular: 1. Botanical raw material: Description, spectroscopic and/or chromatographic fingerprint, material processor, preparation of the raw material, quality control tests and analytical procedures, voucher specimen, certificate of analysis of the raw material, storage conditions 2. Botanical drug substance: Description, chemical identification for active constituents and characteristic markers, specifications, manufacturing process, quality control tests, analytical procedures validation, reference standard, batch analysis, container, stability, container label 3. Botanical drug product: Description, acceptance specifications, manufacturing process, quality control tests, validation reports of analytical procedures, batch analysis, container, stability. Please discuss conformity with ICH Q3C with respect to residual level of solvents, if an ethanolic or hexane extract is being proposed. 4. Placebo 5. Labeling 6. Environmental assessment or claim of exclusion B. NON-CLINICAL CRITERIA 1. Nonclinical data suggesting safety and efficacy of the product for treating benign prostatic hypertrophy. Nonclinical data would normally include: efficacy in vitro and in animal models; toxicity after single and multiple doses in two species; reproductive toxicity in females and in males; mutagenicity/genotoxicity in vitro and in vivo; carcinogenicity data if available; plasma levels of parent compounds and metabolites corresponding to acute and chronic toxicity. Because Saw Palmetto will be clinically administered for more than 1 year in the phase I/II and eventual phase III studies, chronic toxicity studies (with reversal) should be at least 3 months in duration and if possible 6 months in rodents and 9 months in non-rodents. [ICH M3] Special pharmacology/toxicology studies, such as cardiovascular toxicity, neurologic toxicity, and toxicity to indicated target organs, would be highly desirable. 2. Additionally, any available absorption, distribution, metabolism and excretion data should be submitted. C. CLINICAL DATA 1. Clinical data suggesting safety and efficacy of the product for treating or preventing the progression of benign prostatic hypertrophy. 2. Additionally, any available human absorption, distribution, metabolism and excretion data, in normal or compromised populations, should be submitted. Drug-drug interaction studies are highly desirable. 3. Instructions for use. D. REGULATORY DATA 1. A copy of an Investigator Brochure for the product. 2. A list of the countries where your product is in clinical testing or has been approved or marketed, if appropriate. Note that the product must presently be available in the United States. 3. Whether there is an IND or Drug Master File (DMF) on file with the United States Food and Drug Administration (FDA). Please indicate when you filed the application and the current status of the IND or DMF. If you do not have an IND or DMF currently on file with the FDA, please indicate whether you will agree to submit sufficient and appropriate Chemistry, Manufacturing and Controls (CMC) documentation so that an IND can be filed by NCCAM. E1. ABILITY TO SUPPLY PRODUCT FOR PHASE 1 / 2 IND STUDIES 1. The manufacturer must be able to supply sufficient quantity of the formulated Saw Palmetto and matching placebo(s) within proposed specifications for the duration of the clinical trial. For this initial inquiry, manufacturers should assume that in phase 1 / 2 trials, there will be a total of approximately 400 patients receiving Saw Palmetto or matching placebo daily for up to 18 months, and the daily dose will range from approximately 1 pill a day to approximately 3 pills a day. 2. Manufacturing capacity (batch size) for the product. 3. Please indicate when the appropriately packaged final formulation of Saw Palmetto could be made available to the NIH for use in clinical studies. 4. To indicate the reliability of product supply, please delineate the business relationship between ingredient supplier and clinical product manufacturer. E2.ABILITY TO SUPPLY PRODUCT FOR PHASE 3 PIVOTAL TRIALS If phase 1/ 2 and other supporting studies suggest to the company and to NIH in partnership that a phase 3 trial for a clinical indication is appropriate, ability to supply product for approximately 2000 patients administered Saw Palmetto, in dosages to be determined, but possibly 3 pills daily, for 3 years. E3. ABILITY TO PROVIDE OTHER SUPPORT FOR CLINICAL TRIALS 1. Pharmacokinetic support: assay of Saw Palmetto levels in plasma samples drawn from patients in phase 1 / 2 studies. 2. Other clinical trial support
- Record
- SN01020605-W 20060406/060404220349 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |