MICROCURES, INC.

www.microcures.com

347-495-9948

adam@microcures.com

ADAM KRAMER

P2777475

79J36

Active

Non-Manufacturer

2025-02-07

2030-02-07

2026-02-07

ADAM H. KRAMER

www.microcures.com

2025-05-14

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Department of Health and Human Services

PROMOTING TISSUE REPAIR AND FUNCTIONAL RECOVERY AFTER SPINAL CORD INJURY BY TARGETING THE MICROTUBULE REGULATORY PROTEIN FIDGETIN-LIKE 2. - TRAUMATIC SPINAL CORD INJURIES (SCI) IMPACT HUNDREDS OF THOUSANDS OF PEOPLE, AND THERE ARE NO THERAPIES AVAILABLE WHICH CAN PROMOTE REGENERATION AND CLINICAL MEANINGFUL IMPROVEMENTS IN SENSORY, MOTOR, OR AUTONOMIC FUNCTION. FIDGETIN-LIKE 2 (FL2) IS A MICROTUBULE (MT) REGULATORY PROTEIN THAT MODULATES MT DYNAMICS THROUGH ITS PUTATIVE MT-SEVERING ACTIVITY, REGULATING CELL MOTILITY AND AXONAL GROWTH AND GUIDANCE. WE HAVE IDENTIFIED FL2 AS A NEGATIVE REGULATOR OF AXONAL GROWTH AND DEMONSTRATED THAT TARGETED DEPLETION OF FL2 FOLLOWING PERIPHERAL NERVE INJURY ENHANCES FUNCTIONAL NERVE REGENERATION IN RATS. OUR PRELIMINARY STUDIES SHOW THAT FOLLOWING INJURY FL2 IS UPREGULATED AT THE INJURY SITE IN SEVERAL ADULT TISSUES INCLUDING THE SPINAL CORD. BASED ON THESE DATA, MICROCURES HAS DEVELOPED A SIRNA NANOPARTICLE- ENCAPSULATED FORMULATION TO TARGET FL2 AFTER SCI, WHICH CAN BE APPLIED ONTO THE DURA OR INJECTED INTRATHECALLY. IN PILOT STUDIES USING RODENT SCI MODELS, WE FOUND THAT LOCAL DEPLETION OF FL2 FROM THE INJURY SITE USING A NANOPARTICLE-ENCAPSULATED FL2 SIRNA IMPROVED RECOVERY OF LOCOMOTOR FUNCTION. HERE, WE WILL CONDUCT PROOF-OF-FEASIBILITY STUDIES TO DETERMINE THE EFFICACY OF MICROCURES’ NANOPARTICLE FORMULATION IN PROMOTING HEALING USING A RAT CONTUSION MODEL. IN SPECIFIC AIM 1, WE WILL REPEAT OUR PILOT STUDY IN A LARGER COHORT OF ANIMALS, ASSESSING EFFICACY THROUGH EVALUATING RECOVERY OF HINDLIMB LOCOMOTOR FUNCTION AS WELL AS EXPANDING OUR ASSESSMENTS TO INCLUDE BLADDER, SEXUAL, AND SENSORY FUNCTION. IN AIM 2, WE WILL CHARACTERIZE STRUCTURAL AND MORPHOLOGICAL CHANGES AT THE LESION WITH TREATMENT THROUGH A COMBINATION OF MRI/DTI IMAGING AND IMMUNOHISTOCHEMISTRY ANALYSES. IN AIM 3, WE WILL CONDUCT A DISCOVERY-LEVEL TOXICITY STUDY TO CHARACTERIZE THE SAFETY PROFILE OF OUR THERAPEUTIC USING A SUBSET OF THE ANIMALS FROM AIM 1. COMPLETION OF THESE STUDIES WILL PROVIDE STRONG EVIDENCE OF WHETHER OUR THERAPEUTIC FORMULATION, CALLED SIFI2, IS AN EFFECTIVE AND SAFE THERAPEUTIC FOR TREATING SCI, AND WHETHER IT SHOULD BE FURTHER TESTED AND DEVELOPED IN IND-ENABLING STUDIES. FL2 ACTS THROUGH MECHANISMS CONSIDERABLY DIFFERENT FROM OTHER GENES/PROTEINS/FACTORS CURRENTLY BEING INVESTIGATED AS TREATMENTS FOR SCI; TO OUR KNOWLEDGE, THESE STUDIES WOULD REPRESENT THE FIRST REPORTED SUCCESS OF PROMOTING HEALING AFTER SCI THROUGH AN SIRNA-BASED TARGETING OF A MICROTUBULE REGULATORY PROTEIN.

458154.00

0.00

0.00

2023-09-13

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Department of Health and Human Services

A NOVEL THERAPEUTIC TO PROMOTE CORNEAL REPAIR - THE CORNEA IS ONE OF THE MOST IMPORTANT TISSUES IN THE EYE AND ITS TRANSPARENCY IS CRITICAL FOR GOOD VISUAL FUNCTION IN HUMANS. CORNEAL TISSUE INJURIES ARE THE MOST COMMON, EVERYDAY ISSUE FOR PRACTICING OPHTHALMOLOGISTS AND CAN RUN THE GAMUT IN SEVERITY. HEALING OF LARGE CORNEAL WOUNDS, SUCH AS ALKALI BURNS, INVOLVES EXTENDED MIGRATION OF EPITHELIAL CELLS AS WELL AS REINNERVATION OF THE CORNEA. HOWEVER, COMPLICATIONS FROM INJURY INDUCED INFLAMMATION SLOWS THESE PROCESSES AND WORSENS OUTCOMES. THE INABILITY TO SEAL AND REINNERVATE THE CORNEAL EPITHELIUM RESULTS IN PERSISTING INFLAMMATION AND INCREASES THE RISK FOR CORNEAL ULCERATION. AS STRATEGIES FOR WOUND CARE HAVE EVOLVED, MOST INNOVATION HAS CONTINUED TO FOCUS ON MINIMIZING INFLAMMATION. THESE APPROACHES ARE IMPORTANT FOR COAXING CELLS TO MIGRATE AND HEAL THE CORNEAL EPITHELIUM, BUT DO LITTLE FOR REMODELING AND REPAIR OF THE TISSUE, RESULTING IN WEAKLY ATTACHED TISSUE AND SLOW HEALING. THUS, TO IMPROVE PATIENT OUTCOMES THERE IS A NEED FOR A SAFE AND EFFECTIVE THERAPY THAT BOTH EXPEDITES MIGRATION AND REINNERVATION SOON AFTER INJURY AND RESULTS IN A MORE EFFICIENTLY CLOSED AND EFFECTIVELY MATURED WOUND. IDEALLY, MECHANISMS THAT DELIVER FACTORS TO ENHANCE CORNEAL WOUND HEALING WOULD BE SAFE, APPLIED TOPICALLY, REMAIN LOCALIZED AT THE SITE OF APPLICATION, AND PROVIDE A RAPID BUT SUSTAINED RELEASE OF THE ACTIVE REAGENT. FIDGETIN-LIKE 2 (FL2) IS A RECENTLY DISCOVERED REGULATOR OF THE MICROTUBULE CYTOSKELETON THAT SEVERS AND DEPOLYMERIZES MICROTUBULES (MT). DOWN-REGULATION OF FL2 EXPRESSION ENHANCED MT FUNCTION TO PROMOTE CELL MOTILITY IN VITRO AND IMPROVED HEALING BOTH CLINICALLY AND HISTOLOGICALLY IN MURINE ANIMAL MODELS. MICROCURES AIMS TO DEVELOP NANOPARTICLE ENCAPSULATED FL2-SIRNA (SIFI2) TO DIRECTLY ENHANCE THE WOUND-CLOSURE AND HEALING FUNCTION OF CORNEAL EPITHELIAL CELLS AS WELL AS REINNERVATION THEREBY OFFERING THE POTENTIAL FOR ACCELERATED HEALING AND TISSUE REPAIR IN CORNEAL WOUNDS. THUS, WOUND HEALING WOULD REDUCE SCARRING AND PAIN, IMPROVE VISION, AND LOWER THE RISK OF INFECTION DUE TO FASTER WOUND CLOSURE, AS WELL AS IMPROVE RESTORATION OF CORNEAL ARCHITECTURE. IN PROOF OF PRINCIPLE WORK, THE OPTIMAL CONCENTRATION OF SIFI2 WAS DETERMINED IN A RAT MODEL RESULTING IN A SHORTER TIME TO RE-EPITHELIALIZATION, REDUCED CORNEAL OPACITY, AND RESTORATION OF ANATOMICAL CORNEAL STRUCTURE, WITH NO EVIDENCE OF NERVE DAMAGE OR APOPTOSIS. THIS FAST TRACK PHASE II PROPOSAL WILL INITIATE STEPS TOWARDS AN IND FILING, INCLUDING DEFINING THE FORMULATION TO BE USED. THIS WILL BE ACCOMPLISHED OVER FOUR SPECIFIC AIMS: (1) DEVELOP A SIFI2 FORMULATION USING AN EX VIVO BASED ASSAY; (2) EVALUATE TOXICITY IN A RABBIT OCULAR TOLERABILITY MODEL; AND (3) VERIFY EFFICACY IN A RABBIT MODEL OF CORNEAL BURN; AND (4) HOLD A PRE-IND MEETING WITH THE FDA.

1079975.00

0.00

0.00

2025-01-08

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Department of Health and Human Services

A NOVEL THERAPEUTIC THAT HARNESSES MICROTUBULES TO PROMOTE CAVERNOUS NERVE REGENERATION AFTER RADICAL PROSTATECTOMY - RADICAL PROSTATECTOMY (RP) IS A COMMONLY USED TREATMENT OPTION FOR LOCALIZED PROSTATE CANCER, WHICH CARRIES A HIGH RISK FOR DEVELOPMENT OF ERECTILE DYSFUNCTION (ED) BECAUSE OF CAVERNOUS NERVE (CN) INJURY. EVEN NEWER, NERVE-SPARING, ROBOTIC PROCEDURES DO NOT CONVINCINGLY IMPROVE ERECTILE FUNCTION (EF) OUTCOMES AFTER RP. IN ADDITION, ED RESULTING FROM RP IS OFTEN REFRACTORY TO TREATMENT BY ORALLY ADMINISTERED PHOSPHODIESTERASE TYPE 5 INHIBITORS (PDE5I) LEAVING PATIENTS WITH POOR TREATMENT OPTIONS THAT ARE INVASIVE, ASSOCIATED WITH SIDE-EFFECTS, HAVE LIMITED EFFICACY, AND TREAT SYMPTOMS RATHER THAN BEING CURATIVE. THERE IS A REAL AND URGENT NEED TO IDENTIFY NEW THERAPEUTIC STRATEGIES TO TREAT ED ASSOCIATED WITH RP. AS A CONSEQUENCE OF CN INJURY THERE IS DECREASED NEURONAL NITRIC OXIDE (NO) RELEASE IN CORPORAL TISSUE, THE PRIMARY ACTIVATOR OF THE MOLECULAR PATHWAYS LEADING TO AN ERECTION. LOWER LEVELS OF NO RELEASE LEAD TO A FAILURE IN MECHANISMS THAT FACILITATE CAVERNOSAL OXYGENATION, RESULTING IN FIBROSIS AND CAVERNOSAL SMOOTH MUSCLE APOPTOSIS, WHICH THEN ACT AS POTENTIALLY IRREVERSIBLE BARRIERS TO RECOVERY OF EF, EVEN AFTER CN REGENERATION. SINCE EF IS IMPACTED WITHIN 48 HOURS OF CN INJURY, A STRATEGY CALLED “PENILE REHABILITATION” SUCH AS ORAL PDE5I ADMINISTRATION, IS INITIATED AS EARLY AS POSSIBLE AFTER RP WITH THE GOAL OF RAISING BASAL CORPORAL BLOOD FLOW AND PRESERVING PENILE ARCHITECTURE UNTIL THERE IS FUNCTIONAL CN REGENERATION. BASED ON THE CENTRAL ROLE THAT CN INJURY PLAYS IN THE DEVELOPMENT OF ED FOLLOWING RP, OUR NOVEL TREATMENT STRATEGY USES SIRNA TECHNOLOGY TO TARGET EXPRESSION OF A NEWLY DISCOVERED MICROTUBULE REGULATOR, FIDGETIN-LIKE 2 (FL2) TO ENHANCE CN REGENERATION. PRELIMINARY AND PUBLISHED STUDIES SUGGEST FL2 IS A NEGATIVE REGULATOR OF AXON GROWTH AND WOUND REPAIR; IN PHASE I STUDIES A NOVEL LEAD THERAPEUTIC FORMULATION (A “WAFER” RELEASING FL2- SIRNA; SIFI2) WAS IDENTIFIED THAT WHEN ADMINISTERED TO RATS UNDERGOING BILATERAL CN TRANSECTION RESULTED IN VISIBLE CN REGENERATION AND IMPROVED ERECTILE FUNCTION. COMPARED TO OTHER PRE-CLINICAL STRATEGIES UNDER INVESTIGATION FOR CN REGENERATION, SIFI2 IS EXCEPTIONALLY FAST AND EFFECTIVE IN PROMOTING CN REGENERATION, INDUCING REFORMATION OF NERVE TISSUE ACROSS A GAP OF SEVERAL MILLIMETERS, AND RESULTING IN SIGNIFICANT IMPROVEMENT IN ERECTILE FUNCTION AS EARLY AS TWO WEEKS FOLLOWING TRANSECTION. HOWEVER, THIS AND OTHER PRECLINICAL STRATEGIES BEING EXPLORED FOR CN REGENERATION MAY FAIL TO RECOVER OPTIMAL EF BECAUSE IRREVERSIBLE CHANGES MAY OCCUR IN PENILE ARCHITECTURE DURING THE TIME IT TAKES FOR NERVE REGENERATION. THEREFORE, WE WILL EXPLORE A TWO-PRONGED APPROACH ENHANCING NERVE REGENERATION AND MITIGATING CORPORAL TISSUE DAMAGE WHILE THE NERVE IS HEALING. THE GOAL FOR THIS PHASE II PROPOSAL IS TO INITIATE STEPS TOWARDS AN INVESTIGATIONAL NEW DRUG APPLICATION (IND) FILING, OVER THREE SPECIFIC AIMS: (1) EVALUATE THE ABILITY OF ORALLY ADMINISTERED PDE5I TO ENHANCE SIFI2 TREATMENT; (2) INITIATE A GMP START-UP PROGRAM AT A CONTRACT MANUFACTURING ORGANIZATION (CMO); AND (3) EVALUATE TOXICITY OF SIFI2 PRODUCED AT THE CMO.

1686452.00

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0.00

2020-04-16

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Small Business Administration

TO AID SMALL BUSINESSES IN MAINTAINING WORK FORCE DURING COVID-19 PANDEMIC.

0.00

51621.65

51621.65

2020-04-15

Paid in Full

100

51621.65

51621.65

Unanswered

Unknown/NotStated

Female Owned

Non-Veteran

52282.04