Oxford Biomedica - 500 Beiträge pro Seite

[BrauchGeld]

Hallo

Wer Medigene mag wird Oxford Biomedica lieben.
Für diese Aktie spricht die niedrige bewertung knapp 130 mio€ und die superpipeline.
Partner sind u.a. Wyeth und Merck.
Für mehr Infos geht auf die website :

http://www.oxfordbiomedica.co.uk/aboutus.htm


Gruss
B.M.

[BrauchGeld]

Hi

UPDATE 2-UK`s Oxford Biomedica gets approach, shares jump
Wed Jan 19, 2005 06:14 AM ET
(Adds further analyst comment, background)
By Ben Hirschler

LONDON, Jan 19 (Reuters) - Britain`s Oxford Biomedica Plc (OXB.L: Quote, Profile, Research) , a gene therapy specialist, said on Wednesday it had received an approach and was in talks about a potential merger, sending its shares as much as one-fifth higher.

The company, responding to a recent rise in its share price, said in a brief statement that the talks were at an early stage and may or may not lead to an offer.

The stock was 14 percent higher at 22 pence by 1040 GMT, valuing the company at some 82 million pounds ($153.4 million), after earlier hitting a 10-month high of 23-1/2p.

Industry analyst Chris Redhead of Code Securities said the firm could be a good match for European players operating in the same area, such as Transgene (TRNG.LN: Quote, Profile, Research) of France or Germany`s Medigene (MDGGn.DE: Quote, Profile, Research) .

But it might also be in the sights of a larger U.S. or European drug company looking to expand in the emerging field of cancer vaccines, where Oxford Biomedica has valuable expertise.

"The whole area of cancer vaccines is much more attractive than it was a few years ago," Redhead said.

Sam Fazeli of Nomura said another possibility was that the group was been stalked by a private biotech company looking to reverse into it, in order to build critical mass and achieve a stock market listing.

"It might be that people are more interested in the cash and the listing than anything else," he said.

Oxford Biomedica, which is still loss-making, had cash and short-term investments of 26.2 million pounds at the end of June last year.

Its most promising product is TroVax, which is still at a relatively early stage of development and is not expected to reach the market before 2008 at the earliest.

The cancer vaccine works by triggering a tumour-fighting immune response in patients undergoing chemotherapy treatment for colorectal cancer.

Oxford Biomedica announced last year that it was in negotiations with a number of biotechnology and pharmaceutical companies to license the marketing rights to TroVax, following encouraging results from clinical trials.

It has already licensed its LentiVector gene delivery technology to a number of drugmakers, including U.S. groups Merck & Co Inc (MRK.N: Quote, Profile, Research) and Biogen Idec (BIIB.O: Quote, Profile, Research) . (Additional reporting by Mike Elliott)

Gruss
B.M.

[BrauchGeld]

Oxford BioMedica plc (the `Company`)

Notification of Major Interests in Shares

The Company has received notification from Calyon Corporate and Investment Bank
that on 28 January 2005, Credit Agricole Cheuvreux International Ltd had an
interest in 26,802,000 Oxford BioMedica plc 1p ordinary shares. This represents
7.19% of the presently issued share capital of the Company, which stands at
372,841,990 shares.

[BrauchGeld]

Hi

Positive daten von 2.3.05:

Oxford Biomedica PLC
02 March 2005


FOR IMMEDIATE RELEASE 2 MARCH 2005


OXFORD BIOMEDICA ANNOUNCES ENCOURAGING RESULTS FROM THREE PHASE II TRIALS OF
TROVAX IN PATIENTS WITH COLORECTAL CANCER


Oxford, UK - 2 March 2005: Oxford BioMedica (LSE: OXB), the leading gene therapy
company, today announces encouraging results from three ongoing Phase II trials
of TroVax, its lead cancer immunotherapy, in the treatment of metastatic
colorectal cancer.


Highlights of the Phase II trial results:


• In two trials in the first line setting in combination
with chemotherapy:

o 25 patients are evaluable for immunological responses

o 19 patients are evaluable for tumour responses (tumour stabilisation
and tumour shrinkage)

o The primary endpoints of safety and immunological responses have been
achieved

o The secondary endpoint of clinical benefit has exceeded expectation

o The immune response rate was exceptionally high. All 25 patients
mounted immune responses to the 5T4 tumour antigen

o The tumour response rate was better than expected. Eighteen of 19
patients responded to treatment (three complete responses, ten partial
responses and five disease stabilisations)

o Chemotherapy did not affect the frequency of immune responses compared
to the Phase I/II trials in second line treatment

• In Cancer Research UK`s trial in the (neo) adjuvant to
surgery setting, all eight evaluable patients mounted immune responses

• In all three trials, TroVax has an excellent safety
profile to date. No serious adverse events were attributed to the product


New data from two trials in first line treatment of metastatic colorectal cancer
with concomitant chemotherapy have confirmed previous indications that the
primary endpoints of safety and immunological responses have been achieved. All
patients that have reached the interim stage of the trial have shown an immune
response to the 5T4 tumour antigen.


Today, the Company is also reporting that, in the two trials, the secondary
endpoint of clinical benefit has exceeded expectation. Eighteen of 19 evaluable
patients responded to treatment. Whilst five patients had disease stabilisation
following treatment, 13 of the 19 patients were defined as clinical responders
according to industry standard criteria. These comprised three complete (total
tumour shrinkage) responders and ten partial (more than 30 per cent tumour
shrinkage) responders.



In addition, analysis of the first evaluable patients in a third Phase II trial
of TroVax in colorectal cancer patients undergoing surgery for liver metastases
has shown that all patients have mounted an immune response against the target
tumour antigen. This investigator initiated trial is sponsored by Cancer
Research UK.


The results from the earlier Phase I/II studies showed a highly significant
correlation between patients` immune response to TroVax and time to disease
progression, which translated into a correlation with improved overall survival.
Data emerging from the Phase II trials suggest that the magnitude and duration
of immune responses may be even greater in first line treatment with concomitant
chemotherapy and in the (neo) adjuvant setting with surgery. The new data
reported today provide further evidence that TroVax may offer potential benefit
to patients with colorectal cancer.


Commenting on the Phase II results with TroVax in colorectal cancer, Professor
Alan Kingsman, Chief Executive of Oxford BioMedica, said: `We are very pleased
with the progress of these three Phase II trials of TroVax in colorectal cancer.
The high frequency of anti-5T4 responses in patients confirms the immunological
effectiveness of TroVax and the preliminary clinical response data look
promising. Based on current data, we are optimistic that TroVax will have a role
to play in the treatment of cancer and we look forward to testing this in
pivotal clinical studies.`


Commenting on Cancer Research UK`s initial Phase II results with TroVax in the
adjuvant setting, Dr. Sally Burtles, Director of Drug Development of Cancer
Research UK said: `We are delighted that the vaccine has stimulated an immune
response to 5T4 in all of the evaluable patients to date. Further trials will be
needed to find out if this translates into clinical benefit for patients.`


Phase II trials of TroVax plus chemotherapy in first line treatment

Oxford BioMedica initiated two open label Phase II trials in first line
treatment of metastatic colorectal cancer in 2003. The two trials were designed
to investigate whether concomitant chemotherapy affected patients` immune
responses to TroVax. Enrolment in both trials (TroVax plus IFL and TroVax plus
FOLFOX) was completed in September 2004. The recruitment objective was to have
ten evaluable patients in each trial. The primary endpoints were safety and
demonstrable immune responses to the 5T4 tumour antigen.


On 1 September 2004, the Company reported that the primary endpoints were likely
to be achieved based on preliminary data from 13 patients who had reached the
interim analysis point, defined as four TroVax immunisations and more than eight
cycles of chemotherapy. Of these patients, 11 (85 per cent) had mounted antibody
and/or cellular anti-5T4 immune responses.


These encouraging results have been confirmed as the trials have progressed. To
date, 25 patients have been assessed at the interim stage of the trial. There
have been no serious adverse events attributed to TroVax treatment and the
number of patients mounting an immune response has risen to 100 per cent with
all 25 patients showing antibody and/or cellular responses to the tumour
antigen.


Furthermore, 19 patients have been assessed for tumour responses (tumour
stabilisation and tumour shrinkage), having received at least three TroVax
immunisations and one or more computed tomography scans. Patients entered the
trial with progressive disease, and 18 of 19 patients had a tumour response
following treatment. Thirteen of 19 patients were classified as clinical
responders, comprising three complete and ten partial responses.


Two independent studies of the chemotherapy regimens alone reported clinical
response rates in evaluable patients of 41 and 50 per cent* respectively
(Douillard et al., The Lancet 2000, vol 355, pp 1041-1047; de Gramont et al.,
Journal of Clinical Immunology 2000, vol 18, pp2938 -2947). However, a precise
comparison with the TroVax trials is not possible owing to differences in the
trial protocols and patient numbers.


Data from the two Phase II trials of TroVax will be presented at the American
Society of Clinical Oncology (ASCO) meeting in Orlando, USA, in May 2005. The
trials are on track to report full safety and immunological data as well as
final tumour response statistics in the second half of 2005. Patient survival,
which can be compared to historical controls, will be reported once the median
survival has been reached in the two trials. This is anticipated towards the end
of 2005.


A more detailed report of these two trials of TroVax with first line
chemotherapy is set out below:


(i) TroVax plus IFL chemotherapy

In the trial of TroVax plus irinotecan, 5-flourouracil and leucovorin, a
chemotherapy combination known as IFL, 19 patients have been recruited. The
treatment regimen comprises six immunisations of TroVax and up to 12 cycles of
chemotherapy. 13 patients have reached the preliminary analysis stage, and all
13 have mounted anti-5T4 immune responses.


Clinical and tumour responses have been assessed in 11 patients that have
received four TroVax immunisations and completed chemotherapy treatment. Ten of
11 patients responded to treatment. Three patients had stable disease, while
seven patients (64 per cent*) mounted clinical responses, comprising one
complete response and six partial responses. For reference, the two-arm pivotal
trial that supported approval of IFL chemotherapy alone in first line treatment
of metastatic colorectal cancer, in a total of 338 patients, showed a clinical
response rate of 41 per cent* for the evaluable IFL group (Douillard et al.,
2000).


(ii) TroVax plus FOLFOX chemotherapy

The TroVax plus FOLFOX trial has recruited 17 patients, similarly receiving six
immunisations of TroVax alongside chemotherapy. The current status is that 12
patients have reached the preliminary stage for immunological analysis and eight
patients are evaluable for tumour responses. At the preliminary stage of four
TroVax immunisations and eight cycles of chemotherapy, all 12 patients have
mounted anti-5T4 immune responses.


Clinical responses were observed in six of the eight (75 per cent*) presently
evaluable patients, comprising two complete responses and four partial
responses. The two other evaluable patients experienced disease stabilisation
following treatment, meaning that 100 per cent of evaluable patients responded
to treatment. An independent two-arm trial with a comparable FOLFOX chemotherapy
regimen and enrolment criteria, reported a confirmed clinical response rate of
50 per cent* and a tumour response rate, which includes disease stabilisation,
of 82 per cent in a total of 420 patients (de Gramont et al., 2000).


Phase II trial of TroVax in patients undergoing surgery for resectable liver
metastases

An investigator initiated, open label Phase II trial started in 2004, with
sponsorship from Cancer Research UK, in colorectal cancer patients who have
operable liver metastases. Patients receive TroVax immunisations before
(neoadjuvant) and after (adjuvant) surgery. Recruitment into this 20-patient
trial is over halfway completed.


Eleven patients have received the initial regimen of TroVax immunisations, two
of which were subsequently withdrawn for being ineligible for surgery. The eight
evaluable patients have achieved the primary endpoint of immune responses to the
5T4 tumour antigen, and are eligible for further TroVax doses. The most recent
patient has not progressed far enough through the trial to assess immune
responsiveness. TroVax has been safe and well tolerated in all patients treated
to date in this trial.


The treatment schedule comprises two immunisations with TroVax before and after
liver surgery and, potentially, a further two vaccinations. The endpoints of the
study are safety, immunological responses to 5T4 and clinical benefit. Following
surgery, these patients have a lower tumour burden and longer survival
expectation than patients in Oxford BioMedica`s other Phase II trials in
colorectal cancer. This potentially makes them even more responsive to
immunotherapy approaches such as TroVax. Patients are generally not given
chemotherapy following liver surgery and there is a need for safe and effective
treatments to help prevent disease relapse.


Full results from this Phase II trial of TroVax in the (neo) adjuvant setting of
colorectal cancer treatment will be published in an appropriate clinical journal
by Cancer Research UK once the study is completed.


Conclusion

More than 65 patients with colorectal cancer have been treated with TroVax to
date in four clinical trials. Across all the trials, the safety profile of
TroVax has been excellent and the majority (98 per cent) of assessable patients
(50 patients) have mounted immune responses following treatment with TroVax.
This is an exceptionally high response rate in the context of clinical studies
with other cancer vaccines (Mocellin et al., Lancet Oncology 2004; vol 5:
681-9). TroVax has been investigated in different settings in these trials -
first line treatment with chemotherapy, second line treatment and the (neo)
adjuvant setting with surgery - and achieved its primary endpoints in each
setting.


These data suggest that TroVax has therapeutic potential across all stages of
colorectal cancer, supporting the notion that the product may reach large
markets in this indication.


The Company and its clinical advisors are refining a strategy to achieve
potential product registration of TroVax in 2008-09. This will provide Oxford
BioMedica and its potential partners with a clear and rapid route to product
commercialisation.


Other TroVax trials

In addition to the three ongoing Phase II trials in colorectal cancer, Oxford
BioMedica is expanding the opportunity for TroVax to other tumour types. The
Company believes that metastatic renal cell carcinoma (RCC) offers an attractive
commercial opportunity for the development of TroVax. Studies show that the 5T4
antigen is present on over 90 per cent of RCC samples; current treatment options
are ineffective or have serious side effects; and TroVax could benefit from
orphan drug and fast track designations in this indication.


A Phase II trial in RCC with TroVax alongside high dose interleukin-2 is
underway in the United States. Preliminary immunology data are expected around
mid-2005. In breast cancer, the Southwest Oncology Group, which is a US clinical
trials consortium, is expected to start a Phase II trial in late stage patients,
in 2005.

[BrauchGeld]

Hallo

In den letzten Tagen wurden massiv aktien von der Firma gekauft,nachdem bekannt geworden ist das Pfizer interesse an Oxford Bio hat.

Oxford BioMedica plc (the `Company`)

Notification of Major Interests in Shares

The Company has received notification from Man Financial Limited that on 14
April 2005 it had an interest in 26,275,800 Oxford BioMedica plc 1p ordinary
shares. This represents 7.02% of the presently issued share capital of the
Company, which stands at 374,247,162 shares.

Oxford BioMedica plc (the `Company`)

Notification of Major Interests in Shares

The Company has received notification today from UBS AG that on 18
April 2005 it, acting through its business and legal entities, had an interest
in 11,351,250 Oxford BioMedica plc 1p ordinary shares. This represents 3.03% of
the presently issued share capital of the Company, which stands at 374,315,769
shares.

Oxford BioMedica plc (the `Company`)

Notification of Major Interests in Shares

The Company has received notification today from Calyon Corporate and Investment
Bank that Credit Agricole Cheuvreux International Ltd has an interest in
29,962,000 Oxford BioMedica plc 1p ordinary shares. This represents 8.00% of the
presently issued share capital of the Company, which stands at 374,756,353
shares.