Drugs / AVI-4065
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00381433 | Sep → Oct 2006 | encephalitis | Sarepta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT00229749 | Sep 2005 → Oct 2006 | chronic hepatitis C virus infection | Sarepta Therapeutics, Inc. | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 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 "New Antimicrobials: Preclinical and Clinical Studies," will feature data demonstrating the ability of multiple PMOs, AVI-4020, AVI-4126 and AVI-4065, to cross the blood-brain barrier of normal healthy volunteers. |
| 2006-11-10 | Sarepta Therapeutics, Inc. | Results AVI BioPharma Announces Positive Clinical Trial Results Delivering NEUGENE Antisense Drugs to the Central Nervous System sarepta.com ↗
AVI BioPharma, Inc. (Nasdaq:AVII), today announced human clinical trial results showing that three distinct NEUGENE(R) antisense drugs entered the cerebral spinal fluid (CSF) of healthy adult male volunteers following a single 100 mg dose via intravenous (IV) or subcutaneous (subq) injections. |
| 2006-10-04 | Sarepta Therapeutics, Inc. | Results AVI BioPharma Reports Results on Hepatitis C Virus Clinical Trial sarepta.com ↗
AVI-4065 exhibited favorable safety and tolerability profiles in the 12 patients completing the clinical treatment phase of the protocol, with no serious drug-related adverse events or tolerability issues observed during treatment or follow-up. |
| 2006-05-10 | Sarepta Therapeutics, Inc. | Results AVI BioPharma Presents Initial Results on Hepatitis C Virus Clinical Trial at the International Conference on Antiviral Research Annual Meeting sarepta.com ↗
AVI-4065 exhibited favorable safety and tolerability profiles in all patients treated thus far, with no serious drug-related adverse events or tolerability issues observed during treatment or follow-up. |
| 2006-01-10 | Sarepta Therapeutics, Inc. | Results AVI BioPharma Reports Favorable Safety and Pharmacokinetic Data From Its Clinical Trial Targeting Hepatitis C Virus sarepta.com ↗ |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2011-05-06 | Sarepta Therapeutics, Inc. | 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 ↗ |
| 2006-11-10 | Sarepta Therapeutics, Inc. | AVI BioPharma Announces Positive Clinical Trial Results Delivering NEUGENE Antisense Drugs to the Central Nervous System sarepta.com ↗ |
| 2006-10-04 | Sarepta Therapeutics, Inc. | AVI BioPharma Reports Results on Hepatitis C Virus Clinical Trial sarepta.com ↗ |
| 2006-05-10 | Sarepta Therapeutics, Inc. | AVI BioPharma Presents Initial Results on Hepatitis C Virus Clinical Trial at the International Conference on Antiviral Research Annual Meeting sarepta.com ↗ |
| 2006-01-10 | Sarepta Therapeutics, Inc. | AVI BioPharma Reports Favorable Safety and Pharmacokinetic Data From Its Clinical Trial Targeting Hepatitis C Virus sarepta.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVI-4065 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00381433 ↗ |
| Action | Inhibit | “AVI-4065 can inhibit HCV RNA dependent PNA polymerase (RdRp encoded in NS5) and the HCV protease (NS3)” NCT00229749 ↗ |
| Modality | Oligonucleotide (other) | “Phosphorodiamidate Morpholino Oligomer (PMO) synthetic chemistry” NCT00229749 ↗ |
| Route | Subcutaneous | “subcutaneous injections given twice a day for 14-days” NCT00229749 ↗ |