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Lipoxen PLC (XEN)

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Monday 18 October, 2010

Lipoxen PLC

LATEST RESULTS ON PROPRIETARY

RNS Number : 5049U
Lipoxen PLC
18 October 2010
 



For Immediate Release

18 October 2010

 

                                                      LIPOXEN

LATEST RESULTS ON PROPRIETARY INFLUENZA VACCINE

 

·               Project results validate positive Efficacy findings for Proprietary Influenza Vaccine candidate
·               Company advancing plans to take product candidate into Phase 1 clinical trials within 24 months.
·               Initiation of search for commercial collaboration to accelerate product development.

 

Lipoxen plc (AIM: LPX), ('Lipoxen' or 'the Company') a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and siRNA delivery, announces positive efficacy results for its novel influenza vaccine using its liposomal co-delivery technology "ImuXen" and is advancing plans to capitalise on this pre-clinical success in order to accelerate the candidate into the clinic within 24 months.

 

While Lipoxen has provided interim updates to the market on this Technology Strategy Board part-funded project, the agreed project plan has now been successfully concluded with the positive outcome that the Lipoxen formulation induced protective immunity against challenge with live virulent influenza virus after a single vaccination in a mouse model.  Importantly, the formulation did not require the addition of an adjuvant and contained considerably less protein antigen than current flu vaccines.  Furthermore, a spray dried version of the vaccine was still efficacious even after storage at 37°C for 6 weeks indicating that there is the potential to create a formulation that can withstand storage outside of the cold chain.

 

In April 2009 the Company announced positive pre-clinical data in respect of this proprietary influenza vaccine candidate, noting that:

 

1.   The ImuXen technology platform, as applied to an influenza vaccine had shown an increase in the effectiveness of influenza vaccines of approximately 30-fold.

2.   The technology has the potential to radically increase output of vaccine doses from manufacturing facilities to confer an advantage of up to 10 times existing vaccine production rates -  a major benefit when addressing the challenges to human health in situation of both pandemic and seasonal outbreaks.

3.   The technology avoids the need for "cold chain" storage and distribution as in its dried form it is stable for long periods at high temperatures

 

Lipoxen stated at that time that it was necessary to undertake further studies to specifically validate the significant advantages that a novel influenza vaccine produced using the ImuXen platform technology could deliver. These were focused on three key areas:

 

(a)  Economies of production through the use of less antigen.

(b)  The ability to confer single-shot immunity

(c)  The ability to deliver a cost effective and storage and handling stable product able to be effectively dosed in tropical and sub-tropical climates.

 

 

In short, these latest project results have validated all of the major benefits announced 18 months ago and, based on them, the Company has moved directly to seek EU grant funding to assist in meeting the costs of undertaking a full GMP manufacturing and GLP toxicity, safety and efficacy programme ahead of the Company's planned route to Phase I (safety) studies in man.

 

Subject to the availability of capital - whether internally, from EU grant funding or through commercial partnering Lipoxen has targeted submitting its clinical trial application in Q4 2012.

 

Commenting on the announcement, Scott Maguire, CEO said:

 

"While the vaccine used in this project was designed to mimic current single-strain pandemic vaccines, the ImuXen platform allows the development of multi-valent vaccines with the potential to address the combined demands of therapeutic efficacy and cost effectiveness, the latter being in the light of the continuing demands of governments and other health care payers to reduce the cost of public healthcare.

 

These trial results have underpinned our belief in the long term viability of the ImuXen platform for the development and efficient production of a broad spectrum of vaccine therapies, and have wholly vindicated our early optimism for both the ImuXen technology in general and the influenza vaccine candidate in particular. We are now actively taking steps to commercialise this opportunity in parallel with seeking EU grant funding to take this important proprietary product into the clinic as soon as possible.

 

While a specific influenza product may yet be some years away from any market launch - and by no means taking lightly the challenges of clearing the many clinical hurdles to be overcome along the way - the Company has now put a clear line in the sand over the real commercial  potential vested in the ImuXen platform which can now look to sit alongside our PolyXen technology which has already shown such great promise in both clinical trials and with our leading commercial collaborator, Baxter Healthcare.

 

I believe that these results put Lipoxen firmly on the map as a leading European platform technology company with the potential to offer a full range of delivery solutions for both biologic and vaccine therapies, be this for next generation drugs and vaccines or for patent protected bio-superior products."

 

 

- Ends -

 

For further information, please contact:

Enquiries 

Lipoxen plc

+44 (0)20 7389 5015

M. Scott Maguire, Chief Executive Officer




Singer Capital Markets (nominated adviser)

+44 (0)20 3205 7500

Jeff Keating / Claes Spång




Buchanan Communications

+44 (0)20 7466 5000

Lisa Baderoon, Mark Court, Jessica Fontaine






 

About Lipoxen

Lipoxen plc is a biopharmaceutical company focused on the development of new and improved biologic drugs and vaccines.  Lipoxen has three proprietary patented technology platforms:

 

1) PolyXen - for extending the efficacy and half life of biologic drugs

2) ImuXen - for creating new vaccines and improving existing vaccines

3) SiRNAblate - for the delivery of siRNA

 

Lipoxen's technology is designed to improve the efficacy, safety, stability, biological half-life and immunologic characteristics of its products. 

 

Lipoxen has multiple drug and vaccine programmes in development.  Two products are in clinical development, SuliXen, a long acting insulin and ErepoXen, a long-acting erythropoietin (EPO). Lipoxen's preclinical pipeline includes vaccines against HIV, influenza and malaria and an exclusive license deal with Baxter Healthcare for blood coagulation drugs.

 

The Company has a low-risk business model and out-licenses its proprietary technologies to biopharmaceutical companies that have strong manufacturing and marketing capabilities.  Lipoxen currently has commercial agreements with some of the world's leading biotechnology and pharmaceutical companies including Baxter, Schering-Plough, the Serum Institute of India Limited, Genentech, and Genzyme. Furthermore, Baxter, the Company's third largest shareholder, and management led the £2.9 million fundraising that the Company announced in May 2009. This fundraising was followed up by a £1.2 million placing in April 2010 which was led by the Company's management team.

 

Lipoxen, which was founded in 1997, trades on the AIM Market of the London Stock Exchange under the ticker symbol LPX. More information can be found at the Company's website: www.lipoxen.com.

 

About the Technology Strategy Board

The Technology Strategy Board is a business-led executive non-departmental public body, established by the government.  Its role is to promote and support research into, and development and exploitation of, technology and innovation for the benefit of UK business, in order to increase economic growth and improve the quality of life.  It is sponsored by the Department for Business, Innovation and Skills (BIS).  For further information please visit www.innovateuk.org 

 


This information is provided by RNS
The company news service from the London Stock Exchange
 
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