Direct Biologics, LLC - Expanded Access Programs

Expanded Access Intelligence

Official Statements

Score contribution: 100 — 1 supporting sources.

Score 1001 references

Featured Reference

Patients | Direct BiologicsOpens in new window

“Expanded Access is a pathway that allows patients with serious or life-threatening conditions to gain access to investigational therapies outside of clinical trials. While we believe clinical trials are the most appropriate way to evaluate our therapies, we also support patients in need by making our investigational therapies available in emergency or investigational cases.”

EAP Related Articles from Sponsor

Score contribution: 80 — 5 supporting sources.

Score 805 references

Featured Reference

Direct Biologics Reports Compelling Data as ExoFlo™ Expanded Access Program in Hospitalized COVID-19 Patients with Moderate-to-Severe ARDS Surpasses 100 Subjects | Direct BiologicsOpens in new window

Direct Biologics, LLC, a late-stage biotechnology company leveraging its regenerative medicine platform using extracellular vesicles (EVs) secreted from bone marrow-derived mesenchymal stem cells to address multiple disease indications, announces favorable safety and efficacy data from its ExoFlo™ expanded access program in hospitalized adult COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS).

HomeSource

Direct Biologics Reports Compelling Data as ExoFlo™ Expanded Access Program in Hospitalized COVID-19 Patients with Moderate-to-Severe ARDS Surpasses 100 Subjects

Investors | Direct BiologicsSource

Direct Biologics Reports Compelling Data as ExoFlo™ Expanded Access Program in Hospitalized COVID-19 Patients with Moderate-to-Severe ARDS Surpasses 100 Subjects

Direct Biologics Receives FDA Clearance to Initiate Phase 1b/2a Clinical Trial of ExoFlo™ in Patients with Medically Refractory Perianal Fistulizing Crohn’s Disease | Direct BiologicsSource

Direct Biologics is currently conducting the global Phase 3 EXTINGUISH ARDS clinical trial of ExoFlo for the treatment of hospitalized adults with moderate-to-severe acute respiratory distress syndrome (ARDS). In addition, the Company has initiated Phase 1 clinical trials with ExoFlo for the treatment of ulcerative colitis and Crohn’s disease, and expanded access trials in solid abdominal organ transplantation and severe ARDS patients.

Direct Biologics Announces Publication of Significant Survival Benefit with ExoFlo™ in its Phase 2 Randomized Controlled Clinical Trial in the Journal CHEST | Direct BiologicsSource

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 2 supporting sources.

Score 402 references

Featured Reference

Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDSOpens in new window

Conditions: Covid19, ARDS, Hypoxia, Cytokine Storm

Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant PatientsSource

Conditions: Solid Organ Transplant Rejection, Organ Rejection Transplants, Organ Rejection

Reagan-Udall Foundation Insights

Company

Direct Biologics, LLC

Expanded Access Website

https://directbiologics.com/compassionate-use-policy/

Additional Information

Single-Patient EA Policies/Criteria Available Therapies via Single-Patient EA ExoFlo (extracellular vesicles isolated from human bone marrow mesenchymal stromal/stem cells)

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