OctoPlus announces publication of key Phase IIb results for Locteron which confirm Locteron's improved tolerability up to 60 weeks into the SELECT-2 study

Additional tolerability results from two Phase IIb trials of Locteron to be presented at AASLD conference next week

OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO) announces that its licensee Biolex Therapeutics today has published positive interim results at week 60 of the Phase IIb trial, 12 weeks after completion of 48 weeks of treatment with Locteron®. The results are consistent with the existing clinical results for Locteron and confirm Locteron's improved tolerability profile.

Simon Sturge, CEO of OctoPlus, says: "These positive results further demonstrate the value of our PolyActive® technology and show that Locteron's targeted benefits are sustained in the long term, up to 12 weeks after the end of treatment. Based on increasing evidence we believe that interferon alpha will remain a core component of future hepatitis C treatment regimens, and these positive results position Locteron as a key product in hepatitis C therapy."

The following information was taken directly from Biolex' press release, for detailed results we refer to www.biolex.com<http://www.biolex.com/>.

Biolex Therapeutics, Inc. announced positive efficacy, safety and tolerability results from its 72-week SELECT-2 Phase 2b dose-finding Phase 2b trial of Locteron, Biolex's lead product candidate for the treatment of hepatitis C. For each of the three Locteron doses tested in SELECT-2, the percentage of patients who maintained undetectable levels of virus at week 60 of the trial, 12 weeks after completion of 48 weeks of treatment (SVR12), were comparable with or exceeded the response rate for the PEG-Intron® control. As a result of its controlled-release mechanism, Locteron was dosed half as frequently as PEG-Intron. PEG-Intron is one of two currently marketed pegylated interferon products for the treatment of hepatitis C, a market that currently exceeds US$ 2.5 billion in worldwide sales.

Additional results from SELECT-2 demonstrated the substantial tolerability advantages of Locteron. Patients treated with each of the three Locteron doses in SELECT-2 reported a statistically significant reduction in flu-like adverse events (p<0.001) compared to the PEG-Intron

group. Accordingly, Locteron patients in all three dose groups used less concomitant medications (analgesics and antipyretics) than the PEG-Intron patients during the study period. Lastly, patients receiving the two lower doses of Locteron experienced lower rates of depression and discontinuations due to adverse events than patients receiving PEG-Intron.

 

These findings from SELECT-2 are of particular importance as a survey of hepatitis C patients published in the Journal of Viral Hepatitis in 2010 showed that depression and flu-like symptoms were cited as the two most important adverse events impacting patient adherence to treatment.

 

Response rates and tolerability results for SELECT-2 are outlined in the table below.

SELECT-2 interim results

 

 

 

 

 

Locteron

 

 

 

 

640 μg

480 μg

320 μg

PEG-Intron

 

(n=29)

(n=29)

(n=28)

(n=30)

Patients achieving SVR 121

45%

35%

36%

30%

Reduction in flu-like adverse events

69%

68%

71%

n/a

Patients using analgesics

66%

48%

45%

73%

Discontinuations due to adverse events

21%

14%

14%

23%

 

1 Percentage of patients who maintained undetectable levels of virus at week 60 of the trial, 12 weeks after completion of 48 weeks of treatment.

 

"The strong viral response of Locteron achieved with once-every-two-week dosing is an improvement over current interferons, and I am impressed by the consistency of the flu-like effect across trials and different reporting methodologies," said Nezam Afdhal, M.D., Chief of Hepatology at Beth Deaconess Medical Center, Harvard Medical School. "The reduction in symptoms of depression is quite promising and needs to be followed up in additional clinical evaluation. The Locteron safety and tolerability results are clearly important as recent clinical results demonstrate that interferon is likely to remain a core component of future treatment regimens that incorporate the new direct-acting anti-virals, highlighting the need for a more tolerable interferon to reduce the side-effect burden on patients from these multi-drug combinations and maximize their adherence to treatment."

 

AASLD presentation

Biolex also announced today that new tolerability data from two Phase 2b trials of Locteron have been accepted for a late-breaker presentation on November 1, 2010 at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.

For further information, please contact:

Rianne Roukema, Corporate Communications: telephone number +31 (71) 524 1071, or send an e-mail to Investor Relations at IR@octoplus.nl.

 

About Locteron

Locteron is a controlled release formulation of interferon alpha for the treatment of chronic hepatitis C. Locteron combines OctoPlus' controlled release drug delivery technology PolyActive® with Biolex' interferon alpha and is the most advanced product in clinical development incorporating one of OctoPlus' proprietary drug delivery technologies. OctoPlus licensed its commercial rights to Locteron exclusively to Biolex in October 2008.

 

Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.

 

About OctoPlus

OctoPlus is a drug delivery service company committed to the creation of improved pharmaceutical products that are based on OctoPlus' proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. OctoPlus focuses on the development of long-acting, controlled release versions of known protein therapeutics, other drugs, and vaccines on behalf of its clients.

 

The clinically most advanced product incorporating our technology is Biolex Therapeutics' lead product Locteron®, a controlled release formulation of interferon alpha for the treatment of chronic hepatitis C. OctoPlus licensed Locteron exclusively to Biolex in October 2008. Locteron is being manufactured for Biolex by OctoPlus and is currently in Phase IIb clinical studies.

 

In addition, OctoPlus is a leading European provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industries, with a focus on difficult-to-formulate active pharmaceutical ingredients.

 

OctoPlus is listed on Euronext Amsterdam by NYSE Euronext under the symbol OCTO. For more information about OctoPlus, please visit our website www.octoplus.nl.

 

This document may contain certain forward-looking statements relating to the business, financial performance and results of OctoPlus and the industry in which it operates. These statements are based on OctoPlus' current plans, estimates and projections, as well as its expectations of external conditions and events. In particular the words "expect", "anticipate", "predict", "estimate", "project", "plan", "may", "should", "would", "will", "intend", "believe" and similar expressions are intended to identify forward-looking statements. We caution investors that a number of important factors, and the inherent risks and uncertainties that such statements involve, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements. In the event of any inconsistency between an English version and a Dutch version of this document, the English version will prevail over the Dutch version.

 

 

Click here for the press release in PDF format<http://hugin.info/137076/R/1456660/396495.pdf>

Posted: October 2010

View comments

Hide
(web5)