New controlled-release polymer shows promise
OctoPlus has cleared Phase I trials for the first time, showing
promise in a new controlled release treatment of chronic hepatitis
C.
The study drug, Locteron, was developed using OctoPlus's PolyActive technology to deliver BLX-883, a recombinant alfa interferon produced by OctoPlus' co-development partner Biolex Therapeutics.
PolyActive is a biodegradable polymeric drug delivery system that encapsulates drug proteins and lipophilic small molecules and then releases them in a controlled fashion over a period of time.
The technology has already been used by Octoplus in two implantable orthopedic medical devices but this is the first time it has been used in a pharmaceutical compound.
Due to its controlled release formulation, Phase I results showed that Locteron could be effectively administered subcutaneously as a single dose once every two weeks.
Current therapies available use chemically modified pegylated interferons that require dosing every week.
"The gradual release of alfa interferon creates more stable plasma levels by avoiding both high peak and low trough plasma levels, which can lead to an increase in drug efficacy and a decrease in side effects," company spokesperson, Rianne Roukema told In-PharmaTechnologist.com.
"No other hepatitis C therapies available can achieve this."
In a written statement, Dr Joost Holthuis, CEO of OctoPlus commented: "We are now on track for Locteron to fulfill its potential as the best-in-class therapy for the chronic hepatitis C market, currently estimated to be worth $3bn (€2.3bn)."
The alfa interferon for Locteron's future clinical trials program will be made at Biolex Therapeutics' North Carolina facilities. It will then be shipped to Leiden, the Netherlands where OctoPlus will formulate the drug using PolyActive at its good manufacturing practice (cGMP) manufacturing facilities.
From Phase III onwards, OctoPlus plans to outlicence the drug to a larger commercialisation partner.
The company is now exploring with Biolex Therapeutics the use of its PolyActive technology in new treatments for hepatitis B and certain cancers, and is also looking for new development partners to use PolyActive in other new drug applications.
