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As part of IPM’s comprehensive research and development efforts, it has established pre-clinical safety and efficacy testing capabilities for promising microbicide compounds. Through the virology research center at St. George’s, University of London, extensive in vitro drug screening capacity has been established for a range of key characteristics including cytotoxicity as well as anti-HIV activity in various cell lines and cervicovaginal explants. IPM has also provided financial support to others for the pre-clinical development of other candidate microbicides.
By evaluating potential microbicide agents under the same conditions, the most promising drug candidates can be effectively and efficiently prioritized. Requests for use of this screening capability are evaluated according to several criteria including:
- Mechanism of action
- Feasibility as a once a day or sustained release regimen (not dependent on time of coitus)
- Ease and cost of manufacture
- Other information available about the compound (animal safety, formulation, previous human experience, etc)
The availability of the testing service will also depend on the capacity of the screening lab. Priority is given to compounds in the context of other ongoing compound development efforts in the field and at IPM.
IPM offers these screening services for free and data is kept strictly confidential.
Proposals for funding directed at drug development of a microbicide candidate are also initially evaluated via this set of formal laboratory assessments. Even if an applicant has existing data, IPM will independently confirm data that has been submitted for review. To be considered for this process, please submit a completed “Compound Submission Form” to proposals@ipm-microbicides.org. Supplemental information must not exceed 10 pages.
Developing new resources for microbicide researchers is a top priority for IPM. For example, IPM has begun developing appropriate models for pre-clinical testing of an important class of anti-HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Used in combination with other anti-HIV drugs, NNRTIs can block the replication of HIV in a person’s blood. Currently, no animal model for evaluating NNRTI exists. If IPM can successfully develop such a model, it will enable microbicide researchers everywhere to rigorously test this class of drugs on animals before they go into human trials.
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