OctoPlus Presents Positive Results of Locteron Phase I Study

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OctoPlus Presents Positive Results of Locteron Phase I Study

LEIDEN, The Netherlands, April 27, 2006 /PRNewswire/ -- OctoPlus, the drug

delivery and development company, announces today the results of the Phase I

study it has completed with Locteron, its controlled release formulation

of alfa interferon for the treatment of chronic hepatitis C.

Phase I results show that a single dose of Locteron delivered to healthy

volunteers is safe and results supported that Locteron could be effectively

dosed once every two weeks, which is a substantial improvement over the

current pegylated interferons that require dosing every week. The results of

the Phase I study will be presented at the 41st Annual Meeting of the

European Association for the Study of Liver Disease (EASL) meeting this week

in Vienna, Austria. Locteron will enter into Phase II studies in the second

half of 2006.

Locteron is designed to be a best-in-class therapeutic for patients with

chronic hepatitis C, and has the potential to induce less side effects and

to increase therapeutic efficacy and patient compliance compared with

current therapies.

Locteron combines OctoPlus' proprietary PolyActive drug delivery

technology with BLX-883, a recombinant alfa interferon produced by OctoPlus'

co-development partner Biolex Therapeutics (Pittsboro, NC, USA) in its

patented LEX System (SM) and is produced in OctoPlus' cGMP manufacturing

facilities in Leiden, the Netherlands.

Phase I results

The Phase I dose escalation study was designed to evaluate safety,

pharmacokinetics and biomarker response of Locteron in comparison with

PEG-Intron® in healthy volunteers. Phase I results show that Locteron,

given as single doses to healthy volunteers, was well tolerated and safe.

The clinical results confirm a gradual release of alfa interferon after

injection, thus avoiding both high peak and low trough plasma levels.

Flu-like symptoms among the groups receiving Locteron in the study were

reported to be less frequent, less severe and of shorter duration than in

the subjects receiving PEG-Intron. The pharmacokinetics and biomarker

response profile of Locteron support once every 14 days dosing of this

product. This, together with the twice prolonged dosing interval, may result

in a significantly improved safety and tolerability profile for Locteron in

comparison to PEG-Intron. All results obtained support further testing of

Locteron in a Phase II clinical study in patients with chronic hepatitis C

infection.

Dr Joost Holthuis, Chief Executive Officer of OctoPlus, said: " The Phase I

results are very promising and confirmed that Locteron is both safe and

successful in producing a gradual release over two weeks of alfa interferon

after a single injection. We are 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 $3 billion. "

PEG-Intron® is a registered trademark of Schering-Plough.

About OctoPlus

OctoPlus is a product-oriented drug delivery company that focuses on the

development of products based on the company's innovative drug delivery

technologies, in therapeutic areas with high medical need. OctoPlus is also

an internationally established provider of pharmaceutical development

services and GMP manufacturing for pharmaceutical and biotechnology

companies. The company is located in Leiden, the Netherlands.

OctoPlus was founded in 1995 and currently employs more than 120 people. In

January 2005 the company raised EUR 18 million in a second financing round

from an international group of investors: Life Sciences Partners II B.V.

(Amsterdam, the Netherlands), S.R. One, Ltd. (West Conshohocken, PA, USA),

Innoven Partenaires (Paris, France), Fortis Private Equity (Brussels,

Belgium) and SurModics, Inc. (Minneapolis, MN, USA).

Website: www.octoplus.nl

For further information please contact:

OctoPlus

Dr. Joost Holthuis, Chief Executive Officer

Tel: +31-71-5244044

Email:

Financial Dynamics

Philips

Gilbert

Tel: +44-207-269-7169

octoplus@...

CONTACT: OctoPlus, Dr. Joost Holthuis, Chief Executive Officer,

Tel:+31-71-5244044, Email: . Financial Dynamics, Philips, Gilbert,

Tel: +44-207-269-7169 octoplus@...

http://www.engelpub.com/News/Index.cfm?articleid=335143

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[Guest guest]

OctoPlus Presents Positive Results of Locteron Phase I Study

LEIDEN, The Netherlands, April 27, 2006 /PRNewswire/ -- OctoPlus, the drug

delivery and development company, announces today the results of the Phase I

study it has completed with Locteron, its controlled release formulation

of alfa interferon for the treatment of chronic hepatitis C.

Phase I results show that a single dose of Locteron delivered to healthy

volunteers is safe and results supported that Locteron could be effectively

dosed once every two weeks, which is a substantial improvement over the

current pegylated interferons that require dosing every week. The results of

the Phase I study will be presented at the 41st Annual Meeting of the

European Association for the Study of Liver Disease (EASL) meeting this week

in Vienna, Austria. Locteron will enter into Phase II studies in the second

half of 2006.

Locteron is designed to be a best-in-class therapeutic for patients with

chronic hepatitis C, and has the potential to induce less side effects and

to increase therapeutic efficacy and patient compliance compared with

current therapies.

Locteron combines OctoPlus' proprietary PolyActive drug delivery

technology with BLX-883, a recombinant alfa interferon produced by OctoPlus'

co-development partner Biolex Therapeutics (Pittsboro, NC, USA) in its

patented LEX System (SM) and is produced in OctoPlus' cGMP manufacturing

facilities in Leiden, the Netherlands.

Phase I results

The Phase I dose escalation study was designed to evaluate safety,

pharmacokinetics and biomarker response of Locteron in comparison with

PEG-Intron® in healthy volunteers. Phase I results show that Locteron,

given as single doses to healthy volunteers, was well tolerated and safe.

The clinical results confirm a gradual release of alfa interferon after

injection, thus avoiding both high peak and low trough plasma levels.

Flu-like symptoms among the groups receiving Locteron in the study were

reported to be less frequent, less severe and of shorter duration than in

the subjects receiving PEG-Intron. The pharmacokinetics and biomarker

response profile of Locteron support once every 14 days dosing of this

product. This, together with the twice prolonged dosing interval, may result

in a significantly improved safety and tolerability profile for Locteron in

comparison to PEG-Intron. All results obtained support further testing of

Locteron in a Phase II clinical study in patients with chronic hepatitis C

infection.

Dr Joost Holthuis, Chief Executive Officer of OctoPlus, said: " The Phase I

results are very promising and confirmed that Locteron is both safe and

successful in producing a gradual release over two weeks of alfa interferon

after a single injection. We are 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 $3 billion. "

PEG-Intron® is a registered trademark of Schering-Plough.

About OctoPlus

OctoPlus is a product-oriented drug delivery company that focuses on the

development of products based on the company's innovative drug delivery

technologies, in therapeutic areas with high medical need. OctoPlus is also

an internationally established provider of pharmaceutical development

services and GMP manufacturing for pharmaceutical and biotechnology

companies. The company is located in Leiden, the Netherlands.

OctoPlus was founded in 1995 and currently employs more than 120 people. In

January 2005 the company raised EUR 18 million in a second financing round

from an international group of investors: Life Sciences Partners II B.V.

(Amsterdam, the Netherlands), S.R. One, Ltd. (West Conshohocken, PA, USA),

Innoven Partenaires (Paris, France), Fortis Private Equity (Brussels,

Belgium) and SurModics, Inc. (Minneapolis, MN, USA).

Website: www.octoplus.nl

For further information please contact:

OctoPlus

Dr. Joost Holthuis, Chief Executive Officer

Tel: +31-71-5244044

Email:

Financial Dynamics

Philips

Gilbert

Tel: +44-207-269-7169

octoplus@...

CONTACT: OctoPlus, Dr. Joost Holthuis, Chief Executive Officer,

Tel:+31-71-5244044, Email: . Financial Dynamics, Philips, Gilbert,

Tel: +44-207-269-7169 octoplus@...

http://www.engelpub.com/News/Index.cfm?articleid=335143

_________________________________________________________________

Don’t just search. Find. Check out the new MSN Search!

http://search.msn.click-url.com/go/onm00200636ave/direct/01/