Evaluation of Exenatide in a MitoPark Mouse Model of Parkinson¡¯s Disease

Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
State: Ohio
Type of Government: Federal
FSC Category:
  • 29 - Engine Accessories
NAICS Category:
  • 541990 - All Other Professional, Scientific, and Technical Services
Posted Date: Jun 29, 2020
Due Date: Jul 14, 2020
Solicitation No: HHS-NIH-NIDA-75N95020Q00171
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Evaluation of Exenatide in a MitoPark Mouse Model of Parkinson’s Disease
Active
Contract Opportunity
Notice ID
HHS-NIH-NIDA-75N95020Q00171
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
NATIONAL INSTITUTES OF HEALTH
Office
NATIONAL INSTITUTES OF HEALTH NIDA
General Information
  • Contract Opportunity Type: Sources Sought (Original)
  • All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
  • Original Published Date: Jun 29, 2020 05:04 pm EDT
  • Original Response Date: Jul 14, 2020 02:00 pm EDT
  • Inactive Policy: 15 days after response date
  • Original Inactive Date: Jul 29, 2020
  • Initiative:
    • None
Classification
  • Original Set Aside:
  • Product Service Code: B529 - SPECIAL STUDIES/ANALYSIS- SCIENTIFIC DATA
  • NAICS Code: 541990 - All Other Professional, Scientific, and Technical Services
  • Place of Performance:
    Cleveland , OH 44106
    USA
Description

Description: This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Background: Preclinical studies in mice to evaluate the repurposing of an approved type 2 diabetes mellitus drug, Exenatide, for the treatment of Parkinson’s disease - for which there is no current pharmacological treatment that slows disease progression.

The evaluation of preclinical efficacy of a new treatment strategy for Parkinson’s disease to evaluate Exenatide on disease progression

Purpose and Objectives: This contract is to evaluate the efficacy of an approved and well tolerated type 2 diabetes Mellitus drug, Exenatide, in a disease progressive mouse model of Parkinson’s disease – the MitoPark mouse that has parallels to the human disorder.

Project requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Specifics outlined below:

Specifics:

Exenatide studies. Exenatide will be provided by the Government who will oversee the scientific basis of the project. The Exenatide will be in the form of the sustained release form, PT320. This will be clinical grade material and will be administered subcutaneously once every two weeks.

(i) The dose of PT320 will be 0.6 mg/kg, subcutaneously once every 2 weeks.

(ii) As Exenatide represents only 2% of the drug available within the formulation of PT320 (the remaining 98% is polymers from which it is slowly released from), the total amount of material used is 30 mg/kg of PT320. (This is equivalent to 0.6 mg/kg of Exenatide).

Notably, the PT320 microsphere powder will NOT go into solution – but will form a suspension. It is important to ‘vortex’ just before injecting the PT320 into animals, and that the PT302 material is in suspension immediately prior to each injection

Behavioral Studies

Locomotor activity. 5-10 week old mice shall be habituated to a low-noise experimental environment for 1 h and then placed in an open-field chamber (20 cm x 30 cm x 30 cm) in this environment. A digital camera will be mounted on the ceiling to allow filming the animals while moving freely for 1 hour. The videos shall be analyzed by dedicated software (TopScan®, Clever Sys Inc., VA, USA) to detect rodent movements and behaviors based on video-tracking of multiple individual body parts, posture and frequency of movements. The horizontal movements during 1 hour were taken as distance traveled.

Cylinder test. The cylinder test shall be performed to evaluate vertical movements and axial set. The mice will be habituated to a low-noise experimental environment for 1 h. After habituation, the mice shall be placed in an open-top, clear plastic cylinder (diameter: 20 cm, height 30 cm) for 5 min and behavior recorded by a video camera. Rearing will be counted from video records.

Rotarod test. Rotarod tests shall be performed to evaluate motor coordination and balance. During a training phase, mice will be introduced to walking on the rotating rod (47650 Rota-Rod NG, Ugo Basile, Comerio, Italy) one day before being tested. The training will be completed when all mice were able to walk forward for 720 s at 15 rpm. The accelerating speed (from 5 rpm to 80 rpm within 240 s) rotarod test will be performed 3 times a day every 2 weeks. The time until the animal falls off the rotating rod shall be recorded by observers blinded to the mice genotypes. Trials will be separated by at least 30 min.

[18F]FE-PE2I PET scan imaging for Dopamine Transporter function (or alternative imaging -depending on approval from Dr. Greig TGB/NIA/NIH). Longitudinal imaging studies shall be performed to evaluate the dopaminergic system in brain at approx. 8 and 16 weeks

NAc and striatal brain slice preparation. Brain will be were prepared as described previously for evaluation of immunohistochemistry in NAc and striatal brain slices. Tyrosine hydroxylase levels will be evaluated at approx. 8 and 20 weeks

Fast scan cyclic voltammetry and dopamine measurements in brain slices. FSCV recording will be performed as described previously at 8 and 12 weeks.

Statistics. Statistical analyses of data for DA release input/output curves and behavioral tests will be performed using a two-way analysis of variance (ANOVA) followed by a Bonferroni post hoc test for multiple comparisons. All statistical tests will be two-tailed and performed using appropriate software (GraphPad Prism 5.02, GraphPad Scientific, San Diego, CA, USA). A p-value

Additional Requirements:

ESSENTIAL study Requirements from Contractor

Extensive background in preclinical studies involving the MitoPark mouse model of PD – must demonstrate with peer reviewed publications in Pub Med.

Contractor MUST have previous experience in the use and handling of Exenatide and GLP-1 class of pharmacological drugs – must demonstrate with peer reviewed publications in Pub Med

Anticipated period of performance: The period of performance is 12 months following the award of the contract.

Capability statement /information sought. Respondents must provide, as part of their responses, a capability statement that clearly identifies their ability to provide the service described above. Respondents must also include information regarding their: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information;

The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.

One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.

The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required.

The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested.

The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted.

The response must be submitted to Diedra Prophet at e-mail address Diedra.Prophet@nih.gov and Karen Mahon at e-mail address Karen.Mahon@nih.gov.

The response must be received on or before July 14, 2020, at 2:00 pm Eastern Time.

“Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Attachments/Links
Contact Information
Contracting Office Address
  • c/o 3WFN MSC 6012 301 N Stonestreet Ave
  • Bethesda , MD 20892
  • USA
Primary Point of Contact
Secondary Point of Contact
History
  • Jun 29, 2020 05:04 pm EDTSources Sought (Original)

Related Document

Aug 5, 2020[Presolicitation (Original)] Evaluation of Exenatide in a MitoPark Mouse Model of Parkinson’s Disease
Aug 7, 2020[Presolicitation (Updated)] Evaluation of Exenatide in a MitoPark Mouse Model of Parkinson’s Disease

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