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A decellularized porcine placenta matrix hydrogel for management of radiation-induced proctitis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA272043-01A1
Agency Tracking Number: R41CA272043
Amount: $400,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA21-262
Solicitation Year: 2021
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-06-01
Award End Date (Contract End Date): 2024-05-31
Small Business Information
Folsom, CA 95630-8013
United States
DUNS: 116917272
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (916) 703-5174
Business Contact
Phone: (916) 761-2552
Research Institution
OFFICE OF RESEARCH - SPONSORED PROGRAMS 1850 Research Park Drive, Suite 300
DAVIS, CA 95618-6153
United States

 Nonprofit College or University

Radiation therapy is a widely used treatment modality for pelvic malignancies such as prostate and cervical
cancer; however, the high doses needed to confer therapeutic benefit often inflict significant damage on the
normal issue in and surrounding the radiation field. The most frequent complication of pelvic radiation is proctitis,
which nearly all patients experience acutely and many experience chronically in the months and years following
cessation of therapy. In its most severe form, radiation induced proctitis leads to compromise of the blood supply
to the rectal wall, which results in full thickness ischemia, stenosis, and fecal obstruction. Treatment strategies
follow a pragmatic approach of first-line anti-inflammatories alone or in combination with a steroid, followed by
cytoprotective agents like sucralfate. While these strategies are associated with symptom relief in some cases,
data are not strong enough to support widespread use, leaving clinicians without legitimate evidence-based
therapies to recommend. BrioPryme Biologics, Inc. has developed a single patient/multiuse biologic device
(sterile powder) derived from DeCellularized porcine placenta extracellular Matrix (DCM) that can be rehydrated
at point of use and delivered directly to the anorectum as an enema irrigation. BrioPryme’s DCM hydrogel device
forms a protective layer and adheres onto the mucosal membrane to relieve temporary irritations and provides
a moist environment and a 3D scaffold to optimize wound healing. The DCM hydrogel device can be fully
absorbed within 1-3 hours. It has demonstrated potential to reduce fibrotic progression when applied at time of
injury, and is safe, non-toxic, and neutral towards tumor growth. Case studies in cancer patients that recently
received repeated sessions of pelvic radiotherapy reported significant improvements in proctitis symptoms and
quality of life following self-administration of DCM. Based on these promising studies, BrioPryme has partnered
with University of California Davis Department of Radiation Oncology to define the molecular features of DCM-
mediated repair (AIM 1) and evaluate the efficacy of DCM to alleviate radiation injury and stenosis in a mouse
model of radiation-induced proctitis (AIM 2). Successful completion of the proposed work will establish efficacy
of DCM for the management of skin and mucosal membrane toxicity resulting from radiotherapy and pave the
way for formal clinical evaluation of this claim in cancer patients.

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

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