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Development of Pirenzepine for CIPN

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA213555-01A1
Agency Tracking Number: R41CA213555
Amount: $298,550.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: O
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-05-23
Award End Date (Contract End Date): 2018-07-31
Small Business Information
4685 CONVOY ST #210
San Diego, CA 92111-2339
United States
DUNS: 078868444
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ANDREW MIZISIN
 (858) 336-9084
 amizisin@winsantor.com
Business Contact
 STANLEY KIM
Phone: (858) 336-8094
Email: skim@winsantorbio.com
Research Institution
 UNIVERSITY OF CALIFORNIA SAN DIEGO
 
9500 Gilman Drive, Mail Code 0934
LA JOLLA, CA 92093-0934
United States

 Nonprofit College or University
Abstract

PROJECT SUMMARY
Chemotherapy induced peripheral neuropathy CIPN is a debilitating complication that can arise from use of a
number of chemotherapeutics and which limits both the dose and duration of cancer treatments with these
agents Up to of cancer patients treated with chemotherapy describe some form of CIPN with sensory
neuropathy being dominant Symptoms vary from tingling and numbness indicative of sensory loss to aspects of
painful neuropathy such as allodynia and spontaneous shooting pains The American Society of Clinical
Oncology makes no recommendations for the prevention of CIPN and provides only a moderate
recommendation for treatment with duloxetine a serotonin norepinephrine reuptake inhibitor for symptomatic
relief of pain
WinSanTor s founders have uncovered a new homeostatic mechanism in sensory neurons that constrains
mitochondrial function which can be exploited to improve energy supply to reverse and to prevent nerve damage
in CIPN We have demonstrated that the muscarinic acetylcholine type receptor M R signaling limits
mitochondrial activity and that antagonizing M R increases the overall respiratory capacity of mitochondria
Additionally we have observed that the M R antagonist pirenzepine can prevent the neuropathy induced by
chemotherapeutic agents The goal of this Phase I STTR project is to assess the therapeutic potential of
pirenzepine as a CIPN intervention that enhances neuronal AMPK activity and restores neuronal energy capacity
to prevent or reverse neuropathy without impeding the chemotherapeutic microtubule stabilizing properties of
paclitaxel To this end our Specific Aims are
Specific Aim Assess the tumoricidal activity of paclitaxel in presence of pirenzepine
Specific Aim Test efficacy of pirenzepine in mouse paclitaxel models of CIPN
The studies proposed herein will advance further pre clinical development of pirenzepine as a potentially first
in class therapy for preventing and or reversing CIPN PROJECT SUMMARY
Chemotherapy induced peripheral neuropathy CIPN is a debilitating complication that can arise from use of a
number of chemotherapeutics and which limits both the dose and duration of cancer treatments with these
agents Up to of cancer patients treated with chemotherapy describe some form of CIPN with sensory
neuropathy being dominant Symptoms vary from tingling and numbness indicative of sensory loss to aspects of
painful neuropathy such as allodynia and spontaneous shooting pains The American Society of Clinical
Oncology makes no recommendations for the prevention of CIPN and provides only a moderate
recommendation for treatment with duloxetine a serotonin norepinephrine reuptake inhibitor for symptomatic
relief of pain
WinSanTor s founders have uncovered a new homeostatic mechanism in sensory neurons that constrains
mitochondrial function which can be exploited to improve energy supply to reverse and to prevent nerve damage
in CIPN We have demonstrated that the muscarinic acetylcholine type receptor M R signaling limits
mitochondrial activity and that antagonizing M R increases the overall respiratory capacity of mitochondria
Additionally we have observed that the M R antagonist pirenzepine can prevent the neuropathy induced by
chemotherapeutic agents The goal of this Phase I STTR project is to assess the therapeutic potential of
pirenzepine as a CIPN intervention that enhances neuronal AMPK activity and restores neuronal energy capacity
to prevent or reverse neuropathy without impeding the chemotherapeutic microtubule stabilizing properties of
paclitaxel To this end our Specific Aims are
Specific Aim Assess the tumoricidal activity of paclitaxel in presence of pirenzepine
Specific Aim Test efficacy of pirenzepine in mouse paclitaxel models of CIPN
The studies proposed herein will advance further pre clinical development of pirenzepine as a potentially first
in class therapy for preventing and or reversing CIPN

* Information listed above is at the time of submission. *

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