THERAPEUTIC COMPOSITION FOR REGENERATION OF PERIODONTIUM

Information

• Research Project
• 2130572

• ApplicationId

  2130572

• Core Project Number

  R44DE009486

• Full Project Number

  5R44DE009486-03

• Serial Number

  9486

• FOA Number

• Sub Project Id

• Project Start Date

  5/1/1991 - 33 years ago

• Project End Date

  9/24/1995 - 29 years ago

• Program Officer Name

• Budget Start Date

  9/30/1994 - 30 years ago

• Budget End Date

  9/24/1995 - 29 years ago

• Fiscal Year

  1994

• Support Year

  3

• Suffix

• Award Notice Date

  9/30/1994 - 30 years ago

Organizations

• CREATIVE BIOMOLECULES, INC.

The goal of this proposed study is the development and refinement of a therapeutic composition that will reliably affect the regeneration of the soft and hard tissue in the periodontium that are lost or damaged due to periodontal disease. During the Phase I portion of this project we have identified a novel composition, platelet-derived growth factor BB (PDGF-BB) combined with dexamethasone (DEX), which exhibited therapeutic efficacy in a primate model of periodontal disease. In addition, a proprietary collagen based delivery system has been identified that provides a biocompatable delivery system for application of the PDGF-BB/DEX therapeutic composition. The specific aims of this Phase II application are to 1) finalize the manufacturing methods for formulation the PDGF-BB/DEX combination with the collagen carrier, 2) evaluate the effect of different concentrations of PDGF-BB and Dexamethasone on in vivo efficacy, and 3) begin initial safety and toxicity studies on the proposed product in preparation for human clinical evaluation.

IC Name

• Activity

  R44

• Administering IC

  DE

• Application Type

  5

• Direct Cost Amount

• Indirect Cost Amount

• Total Cost

• Sub Project Total Cost

• ARRA Funded

• CFDA Code

  121

• Ed Inst. Type

• Funding ICs

• Funding Mechanism

• Study Section

  SRC

• Study Section Name

• Organization Name

  CREATIVE BIOMOLECULES, INC.

• Organization Department

• Organization DUNS

• Organization City

  HOPKINTON

• Organization State

  MA

• Organization Country

  UNITED STATES

• Organization Zip Code

  01748

• Organization District

  UNITED STATES