Drugs / AVI-6003
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01353040 | May → Dec 2011 | Marburg hemorrhagic fever | Sarepta Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2014-10-16 | Sarepta Therapeutics, Inc. | Results Sarepta Therapeutics Announces Publication of Ebola and Marburg Phase I Clinical Study Results in Antimicrobial Agents and Chemotherapy sarepta.com ↗
Results Show PMOplus® Drug Candidates to be Well-Tolerated with no Clinically Significant Effects on any Evaluated Safety Parameters Observed |
| 2012-03-30 | Sarepta Therapeutics, Inc. | Results Data From AVI BioPharma's Infectious Disease Programs to Be Presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases sarepta.com ↗
These studies exhibited positive safety results for each therapeutic candidate in all six dose cohorts, up to a maximum dose of 9 mg/kg. |
| 2012-02-28 | Sarepta Therapeutics, Inc. | Regulatory AVI BioPharma Announces FDA Approval to Proceed With a Modified Dosing of AVI-6003 for Treatment of Marburg Virus sarepta.com ↗
The FDA approved proceeding with the Marburg program using the single oligomer AVI-7288 under the original IND. |
| 2012-02-09 | Sarepta Therapeutics, Inc. | Results Results From Phase I Clinical Trials Demonstrate Positive Safety Data of AVI BioPharma's RNA-Based Therapeutics for Treatment of Ebola and Marburg Viruses sarepta.com ↗ |
| 2011-10-21 | Sarepta Therapeutics, Inc. | Results AVI BioPharma's RNA-Based Therapeutics for Treatment of Ebola and Marburg Viruses Show Positive Safety Data in First Five of Six Cohorts of Phase 1 Clinical Studies sarepta.com ↗
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today announced positive safety results from the first five cohorts of Phase I single ascending dose trials of AVI-6002 and AVI-6003, AVI's lead drug candidates being evaluated for the treatment of Ebola virus and Marburg virus, respectively. |
| 2011-05-06 | Sarepta Therapeutics, Inc. | Results Data From AVI BioPharma's RNA-Based Hemorrhagic Fever and Infectious Disease Programs to Be Presented at the 21st European Congress of Clinical Microbiology and Infectious Diseases sarepta.com ↗
The presentation, which will be given during the session called "Virology (Non-HIV/Non-Hepatitis)" will feature data from animal studies of AVI's lead Ebola and Marburg therapeutics, AVI-6002 and AVI-6003, respectively, in Ebola and Marburg infected nonhuman primate models. |
| 2010-08-23 | Sarepta Therapeutics, Inc. | Results Nature Medicine Publishes AVI BioPharma Preclinical Studies Demonstrating Post-Exposure Efficacy of PMOplus(TM) Oligomers Against Ebola and Marburg Viruses sarepta.com ↗
Treatment of Ebola virus-infected primates with AVI-6002 led to 60% survival, and treatment of Marburg-infected primates with AVI-6003 conferred 100% survival, compared to control groups where both viruses were universally lethal. |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVI-6003 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01353040 ↗ |
| Modality | Antisense oligonucleotide | “phosphorodiamidate morpholino antisense oligomers” NCT01353040 ↗ |
| Route | Intravenous | “Single intravenous administration” NCT01353040 ↗ |