OK so you thought the title of the other thread was out of date BUT unfortunately there is no way to edit thread titles.

So here is a new title

This one has got the charts at the top again & has a link to the old one.
http://www.moneyam.com/InvestorsRoom/posts.php?tid=5021

A Second Viral Vector for Gene Therapy in Parkinson's Disease
January 27, 2010

Analysis by: GLG Expert Contributor
Analysis of: Oxford BioMedica Announces Update on ProSavin Phase I/II Trial in Parkinsons Disease And Publication of Preclinical Results
Published at: www.pipelinereview.com
Summary
Oxford Biomedica announces the clinical use of a Lentiviral-based retroviral vector that packages and delivers the enzymatic machinery to produce three distinct dopamine-producing enzymes within neurons of the human striatum afflicted by Parkinson's disease (PD). The Lentivirus is of nonhuman origin and follows advances in human gene therapy for PD primarily using the human, nonpathogenic adeno-associated virus (AAV), which has been safely used in three previous clinical trials for PD.
Analysis
While the genome packaging and delivery capabilities of the Lentivirus are significantly more than that of the AAV, it remains unclear as to whether the clinical effects of the triple enzyme delivery (TH, AADC, and GCH1) is significantly better than the delivery of AAV-AADC alone in humans. Early and late published clinical results of AAV-AADC suggest excellent clinical improvement, and AADC gene expression within the treated striatum, visualized with FMT-PET uptake, especially at higher vector doses, which correlates in nonhuman primates with histological gene expression.
As important as the vector is to the packaging and delivery of the gene construct to the neuronal cells within the striatum, the delivery method used for the gene infusion appears to make a difference as well. Nonhuman primate data and early clinical evidence suggest that convection-enhanced delivery (CED) is the most efficient delivery method for viral vectors and other therapeutics due to the extensive, homogenous coverage of the target brain region. Injection techniques deliver localized therapeutics which typically fail to cover a large target region like the putamen. Together with intraoperative MRI imaging to visualize the therapeutic infusion in real-time, treating clinicians are able to tailor their infusions to provide more consistent coverage of the target, alter cannula position for improve target coverage, and stop the infusion once the limits of the target are reached by the therapeutic.
Oxford Biomedica's exciting new approach paves the way for packaging additional therapeutics within a larger viral vector, as long as the safety and efficacy mirrors or improves upon what has been achieved with AAV.

Chief business officer Nick Woolf seems very confident in oxb futurean interesting 60 seconds

http://biobusiness.tv/videos/250

Preliminary Results



TIDMOXB

RNS Number : 3388I
Oxford Biomedica PLC
10 March 2010

?

+--------------------------------------------+----------------------+
| For Immediate Release | 10 MARCH 2010 |
+--------------------------------------------+----------------------+




OXFORD BIOMEDICA PLC
PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DECEMBER 2009

Oxford, UK - 10 March 2010: Oxford BioMedica (LSE: OXB), a leading gene therapy
company, today announces its preliminary results for the year ended 31 December
2009.

Operational highlights:
ProSavin : Parkinson's disease
First dose level in Phase I/II trial showed sustained efficacy at 12
months
Enhanced administration has potential to accelerate development
Regulatory approval to evaluate higher dose level
Ground-breaking preclinical results published in journal

Ocular gene therapies
Landmark partnership with sanofi-aventis in ophthalmology
Received US$26 million upfront payment
Committed funding for three years to develop four gene therapies
RetinoStat and StarGen on track to enter clinical development in 2010

TroVax : cancer
Further analysis of Phase III TRIST study confirmed subset efficacy
Received US$17.4 million regarding termination from sanofi-aventis
Support from FDA for further trials in multiple cancers
Phase II trial in prostate cancer expected to start in 2010

Financial highlights1:
Revenue of GBP19.1 million (2008: GBP18.4 million)
Research & development costs of GBP18.3 million (2008: GBP27.0 million)
Net loss before exceptional items of GBP9.5 million (2008: GBP5.5 million)
Net loss after exceptional items of GBP3.5 million (2008: GBP10.0 million)
Net cash generated2 of GBP3.0 million (2008: net cash burn2 of GBP16.9
million)
Net cash3 of GBP25.3 million (2008: GBP21.9 million)

1. Audited financial results
2. Net cash generated by/used in operating activities plus sales and
purchases of non-current assets
3. Cash, cash equivalents and current financial assets

Commenting on the 2009 annual results, Oxford BioMedica's Chief Executive
Officer, John Dawson said: "I am very pleased with our achievements during 2009.
Our strategic decision to focus our internal development efforts and to expand
our partnering activities is delivering results. The scope and potential value
of our ocular collaboration with sanofi-aventis is testament to this strategy.
We are building the value of our lead product candidates, ProSavin and TroVax,
by advancing their development while pursuing partnership opportunities for both
programmes. Furthermore, we are on track to start clinical development of our
first two ocular gene therapies during 2010. Our vision is to create a
sustainable, highly profitable biopharmaceutical company and we are well
positioned to achieve this goal."

-Ends-
----------------------------------------------------


All sounds great to me.partners and deal for this yeartrovax still looking goodProvSavin heading in the right directionthe SP must move several % today?

Ark/Oxford BioMedica merger touted as Cerepro file is pulled
09 March 2010
Ark Therapeutics is in talks about a possible sale of the company after European regulators informed the UK firm that an expensive additional clinical trial is needed before its brain cancer drug Cerepro could be given the green light.

Edison Investment Research Limited
Mar 12
2010 No surprises in results
Oxford BioMedica remains an attractive recovery play: its current market cap implies little value is attributed to TroVax and the upside potential in the stock. With a solid cash position of 25.3m, the company has a good chance of partnering ProSavin on attractive economic terms (and re-partnering TroVax) in 2010. The year should also bring clinical catalysts, including further ProSavin Phase I/II data and the initiation of new trials Phase IIb for TroVax in prostate cancer, Phase I/IIa for two ocular assets.

Interesting post that answers a few questions>

Tuco 1 - 29 Mar'10

All,
I have spoken with someone at OXB this morning and can confirm that the amount of stock on loan (borrowed to support a short position ) has gone from 1% to over 3% in the last month
OXB confirm that no institution have been selling.

RNS Number : 5026K Oxford Biomedica PLC 21 April 2010

Nick Woolf leaving to go and live down underby all accounts a good guy and one that oxb did not want to loose
I did like his personal comment:- Nick Woolf commented: "It has been a difficult personal decision to leave Oxford BioMedica, particularly at a time when the Company is pursuing multiple collaborations and exploring other opportunities to build the business.
---------------
Mind youif the wife says we are going.you go!!!

Maybe he is joining Trevillion on a joint venture. I understand Trevillion has a good few bob hidden away.

I'm not seeing this as a significant loss, rather he's gone for career improvement maybe headhunted who knows? - OR it may be family reasons and he's not saying, etc.
I doubt this creates a big-hole in the forward plans of OXB, rather it's a shame, a small glitch etc.....

OXB has plenty of cash, so maybe they should buy into another prospect to bring something to market, to prove they can, etc. I know they are keen to use the money to secvure good terms with a suitable partner, so the chang in direction by Sanoffi was a bitter pill...

OXB plc also announces that its Annual General Meeting ("AGM") will be held on Tuesday 27 April 2010. The meeting will be held at the offices of Morrison & Foerster (UK) LLP, 7th Floor, CityPoint, One Ropemaker Street, London EC2Y 9AW, commencing at 11.00 a.m.

An investors take on yesterdays the AGM :-






In order:-

"The AGM
Was run through quickly. The only issue being that whilst approval was given (on proxies) for the company to increase the share capital by up to 2/3rds WITH pre-emption rights, but the resolution 12 was withdrawn after pressure from big investors. It would have given them the right to allot 10% of share capital on a sale WITHOUT pre-emption rights.
Instead they will have to call a shareholder meeting if they need to do this.

PRESENTATIONS
1. John Dawson - "Headlines"
A run through of Ocular, Trovax, and Prosavin... highlight comment "We HAVE Trovax proof of efficacy...."

2. Stuart Naylor - detail progress
Slide by slide review of the whole product set.

Lentivector.... regulators now have 2 complete years of safe, well tolerated, no side effects
experience in man. Every subsequent application to the regulators for a gene delivery comes with this increasing body of evidence. The Prosavin programme has been slower than they would have liked but "at French regulator pace". They are adding a British centre (in Cambridge)to the French one, which will help broaden the capacity. However, he says, we need to realise just how conservative the regulators are regarding the risk of introducing a gene
into a human brain.
Very confident, lots of added "anecdotal" information which he believes cannot be released to the market, but helps to explain why their confidence is SO high. e.g. ALL Prosavin patients were at the end of their L-dopa and suffering swings between dyskinesia and off states. There are golfers now doing a full round, patients living normal lives and even one who has "taken up DIY"! "UDPRS scores tell something but not the quality of life story."
The animal model has shown that the new infusion method has a much more significant improvement at lower dose levels. If repeated in human trial they may not need to escalate further two levels (which they have permission to do).
Prosavin P3 expected to commence in 2011.

Ocular progress as planned, two of these into clinical trial in man in Q4 2010.

"We have clarity on Trovax and the evidence to support efficacy."
Trovax would/will pass a restructured phase 3 now, with what has been learned about blood state.
Their view is that a partner is required to fund a large trial and they don't plan to fund one themselves. Instead they are funding at low levels a series of P2 trial with randomisation and placebo arms.

3. John Dawson - Strategy

He is keen on Mergers and acquisitions and has restructured the company so as to be capable of delivering deals and handling M & A. Gave a "personal success CV" to support these assertions.

Prosavin deal is potentially near. He HAS a term sheet but is still not happy about "one or two of the terms offered". "Will not accept any deal, only the right deal".

Trovax. A number of "suitors" at "early discussions".

M & A - "ongoing evaluation of opportunities."

Sees the financial potential for lead products as follows (in ANNUAL revenues):-
Prosavin $850m peak sales in EU and US
Retinostat $850m
Trovax >$1Bn ("many indications")

4. Q & A

Agreed Prosavin not as well known as they would like. Now have a couple of USA luminaries on the DSMB which should help. But problem IS understood.

What happened to QASAR? - "We missed the boat. At the time that the funding became actually available the TRIST issues were not at all clear."

How long would a Prosavin P3 trial be, given they (the authorities) would have 3 years safe dosage and efficacy knowledge by the time it starts? Probably only one confirmatory trial, 1 year.
So would that mean 2012 approval? "Probably too optimistic".

"However, if the infusion method should deliver results like the pre-clinical, there is the potential for significant acceleration."


5. "INFORMAL" Discussion

I asked Dawson if he speaks to the corporate investors, or are OXB too small an investment?
"I speak to all of them. Especially M & G, who I speak to very often".

Asked Prof Kingsman "you once famously said you wouldn't accept less than 1 per share? Big grin... "Things have changed I guess but I am guessing that your corporate investors are on averages around 25p to 30p, wouldn't you think?" AK: "Probably slightly less, but around that, yes."

AK still considers Prosavin "as good as a cure" and is confident in Trovax efficacy."

More good newsbut I doubt it will affect the SP

RNS Number : 9874N
Oxford Biomedica PLC
24 June 2010








OXFORD BIOMEDICA ANNOUNCES COLLABORATIVE PHASE I/II STUDY TO EVALUATE TROVAX IN MESOTHELIOMA



Oxford, UK - 24 June 2010: Oxford BioMedica (LSE: OXB), a leading gene therapy company, is pleased to announce that it has entered a collaboration with a team of cancer immunologists led by Dr Zsuzsanna Tabi at Cardiff University and in partnership with Dr Jason Lester, an oncologist at Velindre Cancer Centre in Cardiff, to evaluate TroVaxin a Phase I/II study in mesothelioma. The study will be funded by the June Hancock Mesothelioma Research Fund (JHMRF) and Oxford BioMedica will provide TroVax its therapeutic cancer vaccine. The study aims to examine the effect of TroVaxin combination with first-line chemotherapy agents Alimta and cisplatin as a treatment against mesothelioma. This study follows a feasibility project undertaken by Dr. Tabi and her team which was also funded by the June Hancock Mesothelioma Research Fund.

Commenting on today's announcement, Dr Tabi said: "We are very excited aboutconducting this cancer vaccine trial in mesothelioma patients. The continuing support of our work by the June Hancock Fund and collaboration with Oxford BioMedica made this trial possible for which we are very grateful. We hope that patient recruitment can start later in the year."

Therapeutic cancer vaccines can be used in a number of ways. They can be injected into patients to stimulate the body's own defence system to produce immune cells and antibodies which attack the cancer cells by targeting specific markers (antigens) on them. Alternatively, cell-based immunotherapies use the patients' own immune cells, treated in the laboratory to fight cancer cells more effectively, before injecting them back into the patient. TroVaxis a cancer vaccine which targets 5T4, a protein expressed on most common tumour types and which has recently been shown to be present on mesothelioma cells by Dr Tabi and her colleagues. TroVaxhas been shown to be safe and effective at inducing immune responses in other types of cancer but this study will be the first time that it will be used as a treatment for mesothelioma in the UK.

Stuart Naylor, Chief Scientific Officer of Oxford BioMedica, commented: "We are very pleased to have the opportunity to continue to work with the JHMRF and our colleagues at Velindre Hospital. The pioneering work undertaken by Dr. Tabi and her colleagues has identified 5T4 as an exciting new therapeutic target in mesothelioma, a disease which has few treatment options available to patients."

JHMRF is constantly seeking to advance the range and type of treatments on offer to patients by supporting high quality research and exploring novel approaches. JHMRF trustee Dr Kate Hill commented: "The JHMRF is delighted to continue its association with Dr Tabi. The Cardiff immunology team is well established in its field and has shown a tremendous commitment to working with the JHMRF to pursue research in mesothelioma. There are never guarantees in any type of experimental research but we believe that immunotherapy has great potential in the treatment of mesothelioma."

Immunotherapy may offer new ways of attacking tumours by targeting the unique markers on cancer cells. Dendreon, a US biotech company, recently became the first to have a cancer vaccine approved by the US drug licensing agency. It is hoped that this breakthrough demonstrates the potential of immunotherapy products and will stimulate further investment which will ultimately lead to cancer vaccines becoming a standard tool in the oncologist's armoury.

If a Medical Team of Cancer Immunologists are prepared to collaborate with OXB it rather tells the story that Trovax has real potentialcharitably funded to boot!

It seems that there are many that have the confidence and knowledge happy to invest in OXB researchthe publicity dont go a miss either

Business Financial Newswire - Gene therapy company Oxford BioMedica has announced a 255,000 grant by the Motor Neurone Disease Association to fund a collaborative project with Belgium's VIB research institute.

The grant will support further preclinical evaluation of MoNuDin, which is based on Oxford's advanced LentiVector gene-delivery technology, for the treatment of ALS or Lou Gehrig's disease.

Off pisteAlan Greenspan live on CNBC right now

Oxford Biomedica PLC
26 July 2010




OXFORD BIOMEDICA ANNOUNCES FDA APPROVAL FOR TROVAX PHASE II STUDY IN PROSTATE
CANCER

Oxford, UK - 26 July 2010: Oxford BioMedica plc ("Oxford BioMedica" or "the
Company") (LSE: OXB), a leading gene therapy company,announces that it has
received approval from the US Food and Drug Administration (FDA) and Recombinant
DNA Advisory Committee (RAC) to initiate a clinical Phase II study in the United
States to assess the activity of TroVax(MVA-5T4) in patients with progressive
hormone refractory prostate cancer (HRPC).
The randomised, open-label Phase II study will enroll 80 patients with
metastatic HRPC in five centres across the US and will assess the activity of
TroVaxplus chemotherapy drug Docetaxel (Taxotere ), versus Docetaxel alone.
The study will be led by Professor Anna Ferrari, NYU Clinical Cancer Center, and
is anticipated to be initiated by the end of Q3 2010.
Prostate cancer is the second most common cancer in men worldwide. Prostate
cancer hormone therapy involves the removal of the body's testosterone supply
which, for a period of time, will slow or stop the growth and spread of prostate
cancer. Hormone refractory prostate cancer occurs when hormone therapy fails to
stop the growth of prostate cancer.
John Dawson, Chief Executive Officer at Oxford BioMedica, said: "Receiving FDA
and RAC approval is a significant final step in the planning of this study
of TroVaxin patients with HRPC and follows positive analysis of the TRIST
clinical study. We intend this study to be followed by a series of
investigator-led clinical studies and we are pleased to continue the clinical
development of TroVax With the study design now in place, we look forward to
recruiting our first patient and advancing the development of TroVaxin an
important disease area."
-Ends-

Yes, yes, the RNS is easier to read itself - what are your thoughts on the news?

Personally, I'm surprised this trial (ann 26July10) will be over so quickly, but then it's PhII with few patients. What is more important IMHO is the Co. is now addressing male-health issues......far too often "cancer" means (female) breast cancer.
OXB is rather slow in commercialising I fear. I've waited rather too long and may go elsewhere . . . this was my No1 holding, but devasating News has removed that status.

HangonI am invested here for a number of reasons.first of all John Dawson is on record as saying on more than one occasion Prosavin deal is potentially near. . "Will not accept any deal, only the right deal".many investors have been disappointed in Prosavin as results in humans have been short compared to results in the monkeysbut dosage is also lessa 5x could see a difference also Sanofi had a lot of say in the direction oxb went with Trovaxthey paid the bills the company have never said that it was a cure for cancerIt's a vaccine that helps your body fight the diseaseand that is the direction it is now goingno SP value of Trovax is currently priced inwith the latest couple of rns this cannot be right?oxb have plenty of cashbut also could get payments should Retinostat start trialsand lastly it is not beyond the possibility that Sanofi-Aventis come in for oxbthe 10p SP imo has no danger downside the up-side could be interesting?

Pharma Times

BioMedica gets US green light for Trovax trial
26 July 2010
Shares in UK group Oxford BioMedica were on the rise yesterday after it emerged that the company has received clearance from regulators across the pond for a mid-stage trial of its cancer vaccine Trovax.

Both the Food and Drug Administration and Recombinant DNA Advisory Committee have now given a seal of approval for a Phase II study in the US to assess the activity of Trovax in patients with progressive hormone refractory prostate cancer, the second most common cancer in men worldwide.

The decision means that the planned trial - which will be randomised and open label in nature, and should enrol around 80 patients with the disease - can kick off by the end of the third quarter, assessing a regimen of Trovax and the chemotherapy Docetaxel compared to the latter alone in five centres across the country.

The news should be particularly welcomed by the firm as Trovax, targets the tumour antigen 5T4, suffered a significant setback in 2008 after missing a primary endpoint in renal cancer trial. However, following a review of data from the Phase III TRIST study, US regulators approved the companys plans for further development of the cancer vaccine last year.

Clearance of this Phase II trial in prostate cancer follows positive analysis of the TRIST data, and the firm intends this trial to be followed by a series of investigator-led clinical studies, noted John Dawson, Oxford BioMedicas chief executive.

The groups shares closed up 3.74% on the London Stock Exchange following the news.

By Selina McKee

Emergent Licensing Agreement



TIDMOXB

RNS Number : 2314R
Oxford Biomedica PLC
18 August 2010



OXFORD BIOMEDICA ANNOUNCES LICENSING AGREEMENT WITH EMERGENT BIOSOLUTIONS INC.

Oxford, UK - 18 August 2010: Oxford BioMedica ("the Company") (LSE: OXB), a
leading gene therapy company, today announces that it has signed a licensing
agreement with Emergent Product Development Germany GmbH ("Emergent"), a
wholly-owned subsidiary of Emergent BioSolutions Inc. The agreement grants
Emergent non-exclusive rights to Oxford BioMedica's Hi-8 PrimeBoost technology
patents and a sub-licence under poxvirus patents licensed to the Company for the
development and commercialisation of vaccines and therapeutics targeting eight
infectious diseases, including Tuberculosis.

Under the terms of the agreement Emergent will pay an upfront licensing fee of
$1 million, potential milestone payments of up to $20.4 million, and undisclosed
royalties on sales. The milestone payments are based on specified development
successes, including the initiation of future clinical trials, and will be paid
out over several years. One such milestone includes the initiation of a Phase
III trial for the Tuberculosis vaccine candidate being jointly developed by the
Oxford-Emergent Tuberculosis Consortium (OETC) Ltd., a collaboration between
Emergent Product Development UK Ltd. and the University of Oxford.

An effective vaccine usually requires more than one immunisation.
Traditionally, vaccines are given multiple times as "homologous" prime-boosts
using the same delivery system or "vector". Heterologous prime-boost
immunotherapy involves priming the immune system to target an antigen using one
vector and then boosting the response by administration of the same antigen
using a different vector. In many cases this can elicit immune responses of
greater magnitude and breadth than can be achieved by priming and boosting with
the same vector. Oxford BioMedica's Hi-8 PrimeBoost technology is based on the
use of DNA vaccines and recombinant viral vectors.
John Dawson, Chief Executive Officer at Oxford BioMedica, said: "Emergent has a
diverse pipeline of vaccine products and is therefore another strong licensee of
our heterologous prime-boost technology patents."
-Ends

So this licensing agreement could be worth $20-30 mil. over the coming yearsall for non-exclusive rightsand the upfront $1mil. is nicea little vague with the wording potential and undisclosed anyway it is a no lose dealbut i cant see the sp going ballistic25mins to find out?