Locteron^® is designed to require less frequent administration and cause fewer side effects than marketed forms of interferon alfa which currently represent the standard of care for chronic hepatitis C. Locteron has successfully completed clinical Phase II studies. The product has been licensed to Biolex Therapeutics and is being manufactured by OctoPlus.

The Phase IIb clinical study results were presented at the EASL conference in Berlin on 31 March 2011 with two poster presentations:

Click here for the poster titled “SVR for Controlled-Release Interferon Alpha-2b (CR2b) Ribavirin Compared to Pegylated Interferon Alpha-2b (Peg2b) Ribavirin in Treatment-Naïve Genotype-1 (G1) Hepatitis C: Final Results from SELECT-2.”

Click here for the poster titled “Timing and Frequency of Depression During HCV-Treatment with Controlled-Release INFa2b (CR2b) vs. Pegylated IFNa2b (PEG2b), Results from SELECT-2: a Randomized Open-Label 72-week Comparison in 116 Treatment-Naïve Patients with Genotype-1 HCV.”

Locteron has successfully completed a Phase IIa study in 32 chronic hepatitis C genotype I patients. Results from this study confirm Locteron’s potential to substantially improve patient care in HCV. Safety data from the study show a substantially improved tolerability profile for Locteron compared to other interferon products on the market or in development. Efficacy data from the study indicate Locteron’s strong antiviral effect, with 100% of the patients achieving early virologic response in the two highest dose groups. In addition, Locteron is a more convenient therapy than existing treatments due to its controlled-release profile, allowing for once every two weeks drug administration versus the current once a week regimen. Locteron combines OctoPlus’ proprietary biodegradable PolyActive™ drug delivery technology with Biolex’ BLX-883, a recombinant alfa interferon produced in its proprietary LEX System™.

Results of the Phase IIa study were presented in a poster presentation at the AASLD Liver Meeting in Boston in November 2007. Click here to download the poster.

A Phase I clinical study was completed successfully. The safety, pharmacokinetics and pharmacodynamics of Locteron were investigated in healthy volunteers. Results of this Phase I clinical trial showed that a single dose of Locteron was safe and well tolerated. In particular, groups receiving Locteron reported fewer, less severe and shorter lasting flu-like symptoms than those subjects receiving PEG-Intron, a commonly prescribed pegylated interferon. The data from this trial indicate that Locteron could be dosed once-every-two-weeks, which is a substantial improvement over currently used pegylated interferons that require weekly injections.

Results of the Phase I study were presented in a poster presentation at the EASLD Meeting in Vienna in April 2006. Click here to download the poster.
Results of the Phase I study have been published in the peer-review scientific publication the Journal of Interferon and Cytokine Research. Click here to download the article.

Alfa interferon is a protein used to treat infectious diseases, such as hepatitis C and B, and certain cancers. Worldwide sales for hepatitis C therapeutics in 2005 have been estimated at $4 billion.

For more information on Locteron, please contact our Business Development department using the online e-mail form.