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Generoso, G., & Bittencourt, M

Agency Specifics As mentioned, each agency administers the SBIR in its own way

The trial did not resume enrollment Preclinical cardiac evidence: Animal models of myocardial infarction demonstrated RGN-352 reduced scar volume, improved cardiac function, and increased survival, forming the basis for the clinical program (PMID: 25015963) RGN-259 (Thymosin Beta-4 Ophthalmic Solution for Dry Eye): ARISE-1 and ARISE-2 Phase 3 trials: Evaluated Thymosin Beta-4 eye drops for dry eye disease with mixed results some endpoints showed improvement in signs of dry eye, but the pre-specified co-primary endpoints were not met, though some secondary endpoints showed statistically significant improvements in certain signs of dry eye (PMID: 23050815) These ophthalmic trials represent the most advanced clinical testing of any Thymosin Beta-4 formulation Independent Pilot Study (China, 2016): A small pilot study randomized 10 STEMI (heart attack) patients into two groups: 5 receiving Thymosin Beta-4-pretreated endothelial progenitor cells (EPCs) and 5 receiving untreated EPCs After 6 months, the Thymosin Beta-4-pretreated group showed trends toward improved cardiac function markers including ejection fraction and exercise capacity, though the very small sample size (n=5 per group) means these results should be considered hypothesis-generating only, not evidence of efficacy (PMID: 27288307) No severe complications were reported in either group during follow-up Important: This study used Thymosin Beta-4 as a cell pretreatment agent ex vivo (EPCs exposed to TB4 before transplantation), not as a directly administered drug

DSIP administration has been reported in rodent models to attenuate stress-induced elevations of ACTH and corticosterone and to modify behavioral responses to acute stressors (Graf & Kastin, 1984)

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