(OXB.L) Oxford BioMedica PLC Buy/Sell

RNS Number : 7413C
  Oxford Biomedica PLC
  19 November 2009
   

 For Immediate Release  19 NOVEMBER 2009

OXFORD BIOMEDICA PLC

INTERIM MANAGEMET STATEMENT

Oxford, UK - 19 November 2009: Oxford BioMedica (LSE: OXB), a leading gene therapy company, today publishes its interim management statement for the period from 1 July to 18 November 2009. 

Highlights

*     TroVax®: clinical and regulatory support for further trials in several cancer settings

*     ProSavin®: modified administration has potential to enhance and accelerate development 

*     Ocular programmes: on track to start clinical trials in 2010 with sanofi-aventis

*     Financial review: cash burn in line with budget

TroVax® (cancer): clinical and regulatory support for trials in several cancer settings 

Interim results from the Phase III TRIST study of TroVax in renal cancer were presented at the joint congress of the European Cancer Organisation and the European Society for Medical Oncology in September. As previously reported, the TRIST study did not achieve its primary endpoint of an improvement in survival. However, the results confirmed the findings from previous trials, demonstrating that the anti-5T4 immune response induced by TroVax is associated with enhanced survival. Encouragingly, TroVax showed statistically significant survival benefit in one of the pre-defined patient subsets. 

Exploratory analyses of the TRIST data identified a relationship between patients' blood cell counts and TroVax-related survival benefit. In patients with aberrant levels of certain blood cells at the start of the study, TroVax appeared to be less beneficial. Excluding these patients, there was a promising survival trend in favour of TroVax versus placebo. In this patient group, which represented more than 50% of the TRIST population, the indicative efficacy of TroVax was consistent with the level required to meet the study's primary endpoint. In future trials, the ability to select patients who are more likely to mount stronger anti-5T4 immune responses and benefit from TroVax potentially increases the predictability of clinical outcome and the likelihood of successful development.

The competitive landscape for the treatment of renal cancer is considerably more crowded today than when the TRIST study was initiated in 2006. As a result, other cancer settings may offer a more attractive initial route to market for TroVax. The TRIST results have been discussed with the US Food and Drug Administration (FDA). Several settings for possible further development were presented to the FDA. These included ovarian cancer, hormone-refractory prostate cancer and triple-negative breast cancer, which have clear unmet needs and a lack of effective treatments. The agency was supportive of these proposed indications for trials of TroVax. Based on our extensive Phase II data, the FDA also invited submissions for Phase II or adaptive Phase II/III trials in metastatic colorectal cancer.

Following the outcome of the FDA's review in July, we embarked on an initiative to re-partner TroVax. Based on preliminary feedback, prospective partners are attracted by the potential to select patients that are more likely to benefit from TroVax. There remains strong support from clinicians for conducting further trials in our targeted settings and we are exploring funding options through clinical networks. Partnering TroVax for Phase III development remains a key strategic priority for Oxford BioMedica, and discussions are ongoing. Prior to securing a partner, we would only consider supporting cost-effective Phase II trials that are designed to demonstrate proof of concept at the earliest opportunity.

ProSavin® (Parkinson's disease): potential to enhance and accelerate development

We reported further encouraging data from the Phase I/II dose-escalation study of ProSavin in October. Patients at the second dose level showed greater improvement in motor function at their six-month assessments compared to three months. The maximum improvement was 53% and the average was 34% relative to baseline. If confirmed in placebo-controlled studies, ProSavin would represent a significant advance to current treatment options, given its potential to enhance patients' quality of life and suppress the complications caused by oral L-DOPA therapy. 

The excellent safety profile and promising efficacy of ProSavin at the first and second dose levels justify further escalation of the dose. The French regulatory agency (AFSSAPS) is evaluating our proposal to escalate to the allometric human equivalent of the highly efficacious preclinical dose level. In addition, we are seeking to modify the administration procedure using an injection technique that requires fewer needle tracks and reduces the surgery time. Both the study's Data Monitoring Committee and the Company's Scientific Advisory Board support this strategy. Enhancing the efficacy of ProSavin and reducing the surgery time could accelerate the overall development timelines and expand the market opportunity. We anticipate guidance on our proposed amendment from the AFSSAPS before the end of 2009.

The ground-breaking preclinical results were published in the 14 October issue of Science Translational Medicine, a leading scientific journal. The paper described several proof-of-concept studies in the industry-standard preclinical model of severe Parkinson's disease. In this model, ProSavin significantly increased dopamine production from 27% to 47% of normal concentrations without the addition and side-effects of standard L-DOPA therapy. The timing of the publication supports our initiative to raise the profile of ProSavin in other territories and to engage with the European regulatory agency (EMEA) and the FDA. 

As we advance to larger trials, we are negotiating with prospective partners who could add value through their expertise in Parkinson's disease and could bring additional resources for the next stage of development. Our collaboration strategy is to retain certain territorial rights to establish our own specialist sales force for commercialisation of ProSavin.

Ocular programmes: on track to start clinical trials in 2010 with sanofi-aventis

Our collaboration with sanofi-aventis, signed in April, supports the development of our four LentiVector®-based product candidates for ocular diseases. In addition to the upfront payment received, sanofi-aventis has committed up to US$24 million over a three-year period to reimburse our development costs. All four programmes are progressing towards clinical development in 2010-11.

The most advanced candidate is RetinoStat® for wet age-related macular degeneration. We have had a constructive dialogue with the FDA regarding the planned Investigational New Drug (IND) application. The requirements for the IND have been agreed with the agency and we are on track to complete the non-clinical package and submit our IND application in the second half of 2010. 

Our second candidate, StarGen* for Stargardt disease, is also expected to enter clinical development before the end of 2010. We aim to conduct the Phase I/II trial in France with Professor Jos?lain Sahel, Head of the Ophthalmology Department at the Quinze-Vingts Hospital in Paris. Preparations are ongoing and we plan to engage the AFSSAPS within the next few months for formal guidance on our Clinical Trial Application. 

Financial review: cash burn in line with budget

In our interim results, we reported that our net cash1 balance at 30 June 2009 of £34.8 million was sufficient to support our operations into 2012. Expenditure and net cash outflow in the subsequent period to 18 November have been in line with this budget. We continue to review our development priorities against our goals of maximising value and minimising risk through collaborations. We expect to report a net cash inflow for the current year following the significant cash receipts from sanofi-aventis in the first half of 2009 relating to our ocular collaboration and the return of rights to TroVax.    

Oxford BioMedica's Chief Executive Officer, John Dawson, commented: "We have made real progress during the period in both our development and commercial activities. The Phase I/II study of ProSavin continues to yield encouraging data and we are excited by the potential for further enhancement at the next dose level. TroVax is attracting increasing interest and we are working with leading clinicians who have expressed interest in conducting further trials. Our ocular collaboration with sanofi-aventis is on track and the first two products are expected to enter the clinic in 2010. Our partnering efforts are focused on ProSavin and TroVax and we are pursuing other opportunities to accelerate the transformation of Oxford BioMedica into a sustainable biopharmaceutical company. Looking back over my first year as Chief Executive, I am pleased to reflect on our achievements and I look forward to building on this progress."

1. Cash, cash equivalents and current financial assets
       

-Ends-

 For further information, please contact:
 Oxford BioMedica plc: 
 John Dawson, Chief Executive Officer                 Tel: +44 (0)1865 783 000
 Nick Woolf, Chief Business Officer
 JPMorgan Cazenove Limited:
 James Mitford/ Gina Gibson                           Tel: +44 (0)20 7588 2828
 Media/Financial Enquiries:
 Lisa Baderoon/ Mark Court                            Tel: +44 (0)20 7466 5000
 Buchanan Communications
 US Enquiries:
 Thomas Fechtner                                           Tel: (646) 378 2900
 The Trout Group LLC

Notes to editors

1. Oxford BioMedica

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs. The Company's technology platform includes a highly efficient gene delivery system (LentiVector®), which has specific advantages for targeting diseases of the central nervous system and the eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy. Through in-house and collaborative research, Oxford BioMedica has a broad pipeline and its partners include sanofi-aventis, Sigma-Aldrich and Pfizer (formerly Wyeth). Technology licensees include Biogen Idec, GlaxoSmithKline, Merck & Co and Pfizer. Further information is available at www.oxfordbiomedica.co.uk

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

RNS Number : 6771B Oxford Biomedica PLC 30 October 2009

For Immediate Release 30 October 2009

Oxford BioMedica plc ("the Company")

Total Voting Rights Update

In accordance with the FSA's Disclosure and Transparency Rules, Oxford BioMedica plc (LSE:OXB) confirms that as of the date of this announcement the Company's issued share capital consists of 541,185,828 ordinary shares of 1p each, all with voting rights. No shares are held in treasury.

This figure may be used by shareholders as the denominator for the calculation by which they will determine whether they are required to notify their interest in, or a change to their interest in the Company under the FSA's Disclosure and Transparency Rules.

For further information, please contact: Oxford BioMedica plc:
John Dawson, Chief Executive Officer Tel: +44 (0)1865 783 000

Andrew Wood, Chief Financial Officer JPMorgan Cazenove Limited:
James Mitford / Gina Gibson Tel: +44 (0)20 7588 2828

City/Financial Enquiries:
Lisa Baderoon / Mark Court Tel: +44 (0)20 7466 5000

Buchanan Communications

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

TVRBBBDGUXXGGCG

RNS Number : 0232B Oxford Biomedica PLC 19 October 2009

For immediate release 19 October 2009

Oxford BioMedica Plc

Notification of Major Interest in Shares

1. Identity of the issuer or the underlying issuer of existing shares to which voting rights are
attached: Oxford BioMedica Plc

2. Reason for notification (yes/no)
Yes

An acquisition or disposal of voting rights

An acquisition or disposal of financial instruments which may result in the acquisition of shares already issued to which voting rights are attached

An event changing the breakdown of voting rights

Other (please specify):______________

3. Full name of person(s) Barclays PLC

subject to notification obligation:
Barclays Global Investors Ltd

4. Full name of shareholder(s) Barclays Stockbrokers Ltd
(if different from 3): Gerrard Investment Management Ltd
5. Date of transaction (and 15 October 2009

date on which the threshold is crossed or reached if different):

6. Date on which issuer 16 October 2009

notified:

7. Threshold(s) that is/are 6% to 7%

crossed or reached:

8: Notified Details A: Voting rights attached to shares

Class/type of shares Situation previous to the triggering Resulting situation after the triggering transaction

If possible use ISIN code transaction

Number of shares Number of voting Number of shares Number of voting rights Percentage of voting
rights rights
Direct Indirect Direct Indirect
GB0006648157 37,129,139 37,129,139 40,512,129 0 40,512,129 0.00% 7.49%

B: Financial Instruments

Resulting situation after the triggering transaction

Type of financial instrument Expiration date Exercise/ conversion No. of voting rights Percentage of voting
period/date that may be acquired rights
(if the instrument
exercised/converted)

Total (A+B)

Number of voting rights Percentage of voting rights
40,512,129 7.49%

9. Chain of controlled undertakings through which the voting rights and /or the financial instruments are effectively held, if applicable: Barclays Global Investors Ltd Barclays Stockbrokers Ltd Gerrard Investment Management Ltd

Proxy Voting: 10. Name of proxy holder:

11. Number of voting rights proxy holder will cease to hold:

12. Date on which proxy holder will cease to hold voting rights:

13. Additional information:

14 Contact name: Andrew Wood
15. Contact telephone name: 01865 783000

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

HOLUKAORKRRRAAA

LONDON, Oct 15 (Reuters) - British gene therapy specialist Oxford BioMedica said on Thursday patients had responded well to the second dose of its experimental Parkinson's disease drug, ProSavin, news that sent its shares sharply higher.
The firm released fresh data from its Phase I/II clinical trials with ProSavin, which had already produced encouraging initial results in July.
Thursday's data showed that all patients treated at the second dose level with ProSavin had shown further improvement in motor function after completing a six-month assessment.
The maximum improvement was 53 percent and the average was 34 percent relative to patients' pre-treatment motor function, the company said.
ProSavin, which is administered directly to the striatum in the brain, delivers three genes required to convert cells that normally do not produce dopamine into cells that do.
The news sent shares in the company soaring by as much as 102 percent and prompted analysts at Panmure Gordon to upgrade the firm to 'buy' from 'hold', increasing the target price to 17 pence from 12 pence.
"This project represents a significant step-change in technology," said Panmure analyst Savvas Neophytou in a note.

Data released on Wednesday showed that long-term tests on monkeys suggest ProSavin can treat Parkinson's disease without causing the jerky, involuntary movements associated with current drugs.
Shares in British biotech firm Phytopharm rocketed by some 350 percent on Wednesday after it reported promising early test results with its Parkinson's disease drug Cogane.

(Reporting by Kate Kelland and Ben Deighton, Editing by Hans Peters)

((kate.kelland@reuters.com; +44 (0)207 542 0823)) (For more news, please click here)

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