PROVIZIGEN LLC

917-575-9482

provizigen@gmail.com

JIN MONTCLARE

Self-Certified Small Disadvantaged Business, Women-Owned Small Business, Woman Owned

P2952169

KT8KEDVPJJZ8

9GB58

2025-11-22

2024-11-26

2023-01-15

2024-08-20

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National Science Foundation

STTR PHASE I: INJECTABLE BIOTHERAPEUTIC FOR TREATMENT OF POST-TRAUMATIC OSTEOARTHRITIS -THIS SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PHASE I PROJECT DEVELOPS AN INJECTABLE THERAPEUTIC TO TREAT POST-TRAUMATIC OSTEOARTHRITIS (PTOA). PTOA IS A PAINFUL DISEASE OF THE CARTILAGE CAUSED BY EXTERNAL MECHANICAL FORCE. THE CURRENT TREATMENT FOR PTOA INVOLVES AN INVASIVE SURGICAL PROCEDURE - TOTAL JOINT REPLACEMENT - WHICH IS OFTEN ASSOCIATED WITH INFECTIONS AND MAY NEED A REVISION KNEE REPLACEMENT. THERE IS NO DISEASE-MODIFYING OSTEOARTHRITIS DRUG NOR A NON-SURGICAL CURE FOR THESE PATIENTS. WHILE SOME DRUGS HELP MITIGATE PAIN, THEY HAVE NO EFFECT ON DISEASE PROGRESSION, AND THEIR USE CAN BE LIMITED GREATLY BY THEIR POTENTIAL SEVERE SIDE EFFECTS. THIS SOLUTION SERVES AS THE FIRST AND ONLY TREATMENT TO SLOW THE PROGRESSION OF PTOA, WHICH WOULD PREVENT PTOA PATIENTS FROM POTENTIALLY SUFFERING A LIFETIME OF PAIN AND EXPENSES. AS A RESULT, CUSTOMERS WILL POTENTIALLY SAVE THOUSANDS OF DOLLARS, ACQUIRE PEACE OF MIND THAT THEY HAVE TAKEN THE ONLY ACTION TO HELP PREVENT THE DEVELOPMENT OF OSTEOARTHRITIS, AND MOST OF ALL, PREVENT A CYCLE OF INCREASING PAIN, MEDICAL ISSUES, AND ASSOCIATED TREATMENTS WITH THEIR INJURY. THIS SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PHASE I PROJECT WILL LEAD TO AN OPTIMIZED, DEIMMUNIZED THERAPEUTIC THAT CHANGES THE DISEASE PROGRESSION OF POST-TRAUMATIC OSTEOARTHRITIS (PTOA). THE SOLUTION COMBINES A UNIQUE THERMORESPONSIVE HYDROGEL CARRIER CAPABLE OF SUSTAINED DELIVERY OF A THERAPEUTIC PROTEIN THAT ENABLES DISEASE MODIFICATION WHEN DELIVERED VIA A SINGLE INJECTION, AVOIDING THE SURGICAL PROCEDURE IN TOTAL JOINT REPLACEMENT. STATE-OF-THE-ART COMPUTATIONAL TOOLS WILL BE EMPLOYED TO IMPROVE THE PROPERTIES OF THE HYDROGEL AND EXPERIMENTALLY TEST THE CONSTRUCTS FOR FUNCTION. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.

295000.00

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0.00

2023-09-25

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Department of Health and Human Services

ENGINEERED BIOTHERAPEUTIC AGENT FOR TREATMENT OF POST-TRAUMATIC OSTEOARTHRITIS - PROJECT SUMMARY/ABSTRACT POST-TRAUMATIC OSTEOARTHRITIS (PTOA) IS A DEGENERATIVE DISEASE OF CARTILAGE BROUGHT ON BY TRAUMATIC INJURY TO THE ARTICULAR JOINTS. ACUTE JOINT INJURY IS FOLLOWED BY SEVERE JOINT PAIN AND INFLAMMATION. THIS RESULTS IN MUCH MORE RAPID DEGENERATION OF CARTILAGE THAN IN OTHER FORMS OF OSTEOARTHRITIS, DUE TO THE JOINT INSTABILITY CAUSED BY TRAUMA AS WELL AS THE INCREASE IN PROINFLAMMATORY CYTOKINES THAT ACCELERATE DEGENERATION. PTOA AFFECTS 5.6 MILLION AMERICANS, WITH AN ESTIMATED $11.79 BILLION ASSOCIATED WITH DIRECT TREATMENT COSTS FOR ITS TREATMENT. THERE ARE NO APPROVED TREATMENTS THAT STOP OR ALTER THE PROGRESSION OF THE DISEASE, AND COMPLETE DEGENERATION OF THE ARTICULAR CARTILAGE CAN NECESSITATE JOINT REPLACEMENT SURGERY. THIS MAY REQUIRE SURGICAL REVISION IN APPROXIMATELY 10 YEARS, A PARTICULARLY UNDESIRABLE OUTCOME IN YOUNGER PATIENTS WITH LONGER LIFE EXPECTANCIES. PROVIZIGEN HAS DEVELOPED A NOVEL PROTEIN-ENGINEERED INJECTABLE THERAPEUTIC HYDROGEL SYSTEM, HYDROGEN THAT FORMS A GEL WHEN INJECTED INTO THE JOINT SPACE AND PROVIDES SUSTAINED DELIVERY OF AN ANTI-INFLAMMATORY AND CHONDROPROTECTIVE THERAPEUTIC MOLECULE. OUR RECENT PRECLINICAL INVESTIGATION IN A RABBIT ANTERIOR CRUCIATE LIGAMENT (ACL) TRANSECTION MODEL HAS SHOWN THAT IMMEDIATE DELIVERY OF HYDROGEN SIGNIFICANTLY PREVENTS THE DEVELOPMENT OF PTOA AFTER JOINT INJURY AND DELIVERY 8 WEEKS AFTER THE POINT OF INJURY HAS THERAPEUTIC EFFECTS PROMOTING ENDOGENOUS CARTILAGE REPAIR. IN THIS PHASE I STTR, WE AIM TO DETERMINE STABILITY AND LACK OF TOXICITY OF HYDROGEN TO ESTABLISH FUNCTIONAL GELATION AND ESTABLISH SAFE DOSING. IN AIM I, WE WILL DETERMINE THE STABILITY AND MECHANICS OF HYDROGEN BY ASSESSING THE PROTEIN’S MICROSTRUCTURE AND MACROSTRUCTURE, AS WELL AS ITS RHEOLOGIC PROPERTIES AS A FUNCTION OF TEMPERATURE AND TIME TO DETERMINE ITS FUNCTIONALITY AS AN IN SITU GELLING INJECTABLE THERAPEUTIC. IN AIM II, WE WILL ESTABLISH THE LACK OF TOXICITY AND SELECTIVE BIODISTRIBUTION OF HYDROGEN IN A RAT MODEL OF INTRAARTICULAR INJECTION. SUCCESSFUL COMPLETION OF THESE AIMS WILL PREPARE PROVIZIGEN FOR FILING A BLA WITH THE FDA, WITH LARGE ANIMAL PTOA MODEL INVESTIGATION (PHASE II) LEADING TO FIRST IN HUMAN TRIALS.

192259.00

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