apple
- 25 Mar 2004 20:47
Toya
- 06 Jul 2009 07:20
- 1224 of 1451
Webcast today at 09:30 on:
www.oxfordbiomedica.co.uk
to discuss today's RNS:
"Oxford BioMedica is committed to further development of TroVax with a partner and expressions of interest from prospective partners have already been received. Following the positive outcome of the FDA's review, the Company is implementing a broad partnering initiative and is also progressing discussions with clinical trial networks and clinicians who may conduct independent studies of TroVax."
For full details go to:
Positive review by FDA for further development and trials of TroVax
tabasco
- 06 Jul 2009 07:45
- 1225 of 1451
Good morning all>
Great news for all investorsTrovex as was expected is still alive and kickinga partnership deal must be imminent.hopefully a 30% SP rise today as a starterfingers crossed.
.................................
Martin C-J - 30 Jun'09 - 12:39 - 809 of 866
romust - I just talked to OXB and they are just waiting for the actual communication from the FDA to arrive. Any day or moment now. And I don't think there are any nasty surprises.
logga
- 07 Jul 2009 12:42
- 1226 of 1451
how good does news have to be to get a rise???
hangon
- 08 Jul 2009 19:53
- 1227 of 1451
Clearly the "news" isn't all that good, witness sp drifting down! - This "news" just means thaty the FDA accepts that OXB (and their Agents) made a fist of (the failed) Trovax trial-recruitment. That's my "take" FWIW.
This is a bit like the England Cricket Team asking the Umpire to "press Reset" because they are wearing the wrong outfit.
The worry now (IMHO) is that OXB needs to tread carfully so that their "replacement trial" is sufficiently "random" to please the FDA, without cries of "Foul!" . . . . I suspect OXB needs to become more-involved in the patient selection and avoid countries that would use the "treatment" as a form of "National Health" - er, if I understand the nature of the earlier-problem.
It might be better to recruit only genuine english-speaking patients (from Europe and N.America), so at least there is a decent chance any rogues can be eliminated before the trials start.
My other concern is that by permitting this "poor" Trial (now stopped), the Directors of OXB have demonstrated that a cartload of Monkeys would not make a worse fist of wasting Investor's investment by pouring "time" down the drain...er, it says here...the sp was well over 30p until this Trial flopped.
I accept that the outcome is OXB now have "more Cash" (Hooray!) and that "Trovax" appears to be well-tolerated - that is a great relief, then.
tabasco
- 09 Jul 2009 07:07
- 1228 of 1451
Gene therapy boost
3:31pm Wednesday 8th July 2009
By Maggie Hartford
GENE therapy company Oxford Biomedica was boosted by a ruling by US drug regulators that it can continue to develop its cancer vaccine TroVax.
The company's shares rose following an announcement that the US Food and Drug Administration (FDA) had completed a review, acknowledged that confounding factors" may have contributed to the increased number of deaths in a trial of Trovax, the Trist study.
Last year the company axed 13 jobs at its Oxford Science Park headquarters following a fall in its share price after regulators said no more vaccine should be given to the 700-plus kidney cancer patients in the Trist trial.
Dr Stuart Naylor, Oxford BioMedicas chief scientific officer, said: We are encouraged that the results of the Trist study further support the anti-cancer activity of the immune response.
"Our exploratory analyses of this first placebo-controlled, randomised study of TroVax suggest that patients who are more likely to respond to TroVax and benefit from treatment, can be pre-selected.
"Our constructive dialogue with the FDA provides a clear path for further development of TroVax in multiple cancer settings.
Chief executive John Dawson said: The Trist study has yielded valuable insights into the potential for TroVax as a therapeutic cancer vaccine, despite not achieving its primary endpoint.
He added: "We have already received expressions of interest from several pharmaceutical companies that have previously reviewed the programme. We remain committed to the successful development and commercialisation of TroVax.
In May, Oxford Biomedica announced a dealwith pharmaceutical giant Sanofi-aventis giving it enough cash to last until 2012.
tabasco
- 13 Jul 2009 07:20
- 1229 of 1451
ProSavin PhI/II study (Oxford Biomedica)
TIDMOXB
RNS Number : 5402V
Oxford Biomedica PLC
13 July 2009
+---------------------------------------------------+--------------------------+
| For Immediate Release | 13 JULY 2009 |
+---------------------------------------------------+--------------------------+
OXFORD BIOMEDICA ANNOUNCES UPDATE ON PHASE I/II STUDY OF PROSAVIN IN
PARKINSON'S DISEASE
Oxford, UK - 13 July 2009: Oxford BioMedica (LSE: OXB), a leading gene therapy
company, today announces an update on the Phase I/II study of its novel gene
therapy, ProSavin, for the treatment of Parkinson's disease. Patients treated at
the first dose level have maintained their improvement in motor function for one
year, with an average improvement of 29%. Analogous investigator assessments of
patients in the second cohort treated at a higher dose level have
achieved similar benefit at three months, and the first patient to reach their
six-month assessment has demonstrated further improvement. The Data Monitoring
Committee supported Oxford BioMedica's proposal to proceed to a third dose level
incorporating the Company's new administration technology.
The ongoing Phase I/II study is designed to evaluate the safety and efficacy of
ProSavin in patients with mid-stage Parkinson's disease (PD) who are
experiencing reduced benefit on L-DOPA 'equivalent' therapy. ProSavin is
administered directly into the striatum of the brain using a well established
surgical technique. The first stage of the study is a dose escalation in cohorts
of three patients at each dose level and, to date, six patients have been
treated. Three patients that received the first dose level (1x) have reached
their one-year assessments and three patients at the second dose level (2x) have
been assessed at three months post treatment. Motor function is assessed
according to the Unified Parkinson's Disease Rating Score (UPDRS) in patients'
'off state' (i.e. after withdrawal of PD medication).
ProSavin has been safe and well tolerated in all patients, with no serious
adverse events and no evidence of immunotoxicity. All patients have reduced or
maintained their PD medication relative to baseline.
One year after their treatment, patients at the 1x dose have maintained their
improved motor function with an average increase of 29%. All patients have
enhanced their quality of life, based on a standard measure of clinical benefit
that is recorded by the patient using a questionnaire known as PDQ-39. The
average increase in patients' PDQ-39 score was 42% at one year.
At three months, patients at the 2x dose have increased motor function with an
average improvement of 28% and the first of these patients to be assessed at six
months has shown further benefit. All patients in the second cohort
have experienced a better quality of life at three months with an average
improvement of 33%.
The study's independent Data Monitoring Committee (DMC) has reviewed the data,
as required by the study protocol, and supported the Company's proposal to
proceed directly to a third dose level that is five-fold higher than the first
dose level. Oxford BioMedica plans to follow the DMC's recommendation and
incorporate its new delivery technology for the administration of the 5x dose
level of ProSavin. The new technique reduces the surgical time, facilitates
higher dosing and has the potential to provide better reproducibility as study
centres expand and thus accelerate clinical development timelines. A protocol
amendment for the new technology is being prepared, which will be submitted and
reviewed by the French healthcare regulatory agency, AFSSAPS. The Company aims
to complete the submission before the end of the third quarter of 2009.
The Principal Investigator, Professor Sthane Palfi from the
Henri Mondor Hospital in Paris, commented on the results: "The new data are
highly promising, demonstrating long-lasting benefit that is comparable in some
patients to the current alternative of Deep Brain Stimulation. If the higher
dose levels of ProSavin can provide even greater efficacy, then ProSavin would
represent a breakthrough treatment for patients who currently have limited
options when they fail on current medications."
John Dawson, Oxford BioMedica's Chief Executive Officer, added: "We are
delighted by the safety and efficacy data emerging from this first-in-man study
of ProSavin. In parallel with the ongoing trial, we are designing protocols for
the next stage of development, which we will present to both the FDA and EMEA.
Discussions with prospective partners are also progressing well. Our objective
is to complete the current study in the second half of 2010 and advance into
larger studies with a partner as soon as possible."
-Ends-
Toya
- 13 Jul 2009 07:25
- 1230 of 1451
Good news - thanks Tabasco! This is in addition to the positive results they are getting with another drug in development, TroVax, so should (hopefully!) be a good long-term hold.
Oakapples142
- 13 Jul 2009 08:26
- 1231 of 1451
Early trading rather confusing - up 13% immediately following 7 x buys of 30,000 (probably all the same trade !!) and then nothing but sells and back to scratch in minutes. It will be interesting to see how the day unfolds.
Toya
- 15 Jul 2009 16:32
- 1232 of 1451
Interesting to note that today I came across TroVax having been identified by a major pharmaceutical company as a potential threat to their established drug, for a certain type of cancer therapy.
cynic
- 15 Jul 2009 16:37
- 1233 of 1451
what ho ms T!
tabasco
- 05 Aug 2009 07:53
- 1234 of 1451
| For Immediate Release | 5 AUGUST 2009 |
+---------------------------------------------------+--------------------------+
OXFORD BIOMEDICA: NOTICE OF 2009 INTERIM RESULTS
RESULTS DATE: 27 AUGUST 2009
Oxford, UK - 5 August 2009: Oxford BioMedica (LSE: OXB), a leading gene therapy
company, today announces that it will be releasing its interim results for the
six months ended 30 June 2009 on Thursday, 27 August 2009.
Analyst meeting: An analyst briefing will be held at 10:00am on Thursday, 27
August 2009 at the offices of Buchanan Communications, 45 Moorfields, London
EC2Y 9AE.
Web cast: Simultaneously to the analyst briefing at 10:00am, there will be a
live audio web cast of the presentation. To connect to the web cast facility,
please go to the Company's website: http://www.oxfordbiomedica.co.uk/
approximately 10 minutes (09:50am) before the start of the briefing. This will
also be available for replay shortly after the presentation.
-Ends-
hangon
- 05 Aug 2009 19:59
- 1235 of 1451
Whilst it is nice to read of Listed Companies prepared to release web-casts, it is a great shame there isn't a common-format with some "trial" presentation so we punters can align our PC's.
- - - - I have tried past Web-casts on OXB's site but had no success......
The instruction to connect 10mins before the presentation leaves little time to check your settings. (that is, even if I had nothing better to do, ahem).
Toya
- 06 Aug 2009 06:47
- 1236 of 1451
Hangon: you may need to download some software. I've not had a problem with webcasts from OXB and others, and I just use a 'normal' laptop. There's usually a link on the site to whatever it is you need (e.g. Media Player or whatever).
Toya
- 06 Aug 2009 07:00
- 1237 of 1451
Re webcasts: These are run by Buchanan Communications (comms company for OXB and many other minnows). The link below is from their website (http://www.buchanan.uk.com/output/). You need to input your details and then proceed - it usually works.
Registration page for webcast
Good luck!
tabasco
- 07 Aug 2009 07:22
- 1238 of 1451
RNS Number : 0372X
Oxford Biomedica PLC
07 August 2009
For Immediate Release
7 AUGUST 2009
OXFORD BIOMEDICA TO PRESENT AT CANACCORD ADAMS GLOBAL GROWTH CONFERENCE
Oxford, UK - 7 August 2009: Oxford BioMedica (LSE: OXB), a leading gene therapy company, is pleased to announce that John Dawson, its Chief Executive Officer, will present a company update on Tuesday, 11 August 2009 at 9.30am ET (2.30pm BST) at the Canaccord Adams 29th Annual Global Growth Conference being held in Boston, MA.
-Ends-
robstuff
- 14 Aug 2009 13:13
- 1239 of 1451
A sudden flurry of BUYS and the crossing of the all important 11.5 if you're into graph analysis - I'm hoping this is the start of another major rally and should see 20p soon. Maybe good news to come in the 6mth update 27AUG
tabasco
- 19 Aug 2009 07:25
- 1240 of 1451
RNS Number : 6531X
Oxford Biomedica PLC
19 August 2009
For Immediate Release
19 AUGUST 2009
OXFORD BIOMEDICA ANNOUNCES ACCEPTANCE OF LATE-BREAKING ABSTRACT ON TROVAX PHASE III TRIST STUDY FOR PRESENTATION AT ECCO 15-34th ESMO CONGRESS
Oxford, UK - 19 August 2009: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that its late-breaking abstract on the Phase III TRIST study of TroVax, its therapeutic cancer vaccine, in renal cancer has been selected for oral presentation at the joint 15th Congress of the European CanCer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) in Berlin, Germany. Detailed results from the most recent interim analysis of the TRIST study will be presented during a session on 'Genitourinary malignancies - Renal and Other' on 22 September 2009 from 9:00am to 11:15am CET.
The abstract is entitled 'TRIST: A randomised, double blind, placebo controlled Phase III study of MVA-5T4 in metastatic renal cancer patients'. It has been assigned an abstract number of 17LBA in the programme and abstract book, which is expected to be available at www.ecco-org.eu. A special European Journal of Cancer Supplement will also be printed and will include the TRIST abstract amongst other late-breaking and 'best' abstracts from the Congress. These abstracts will receive the highest visibility possible for an abstract presented at this conference.
The Phase III TRIST study is evaluating TroVax plus standard of care against placebo plus standard of care. The trial enrolled 733 patients with advanced or metastatic renal cancer. Despite not achieving its primary endpoint, follow-up analyses of the TRIST study have yielded valuable insights into the efficacy of TroVax, demonstrating further evidence of clinical activity and significant survival advantages to TroVax in subsets of patients.
John Dawson, Oxford BioMedica's Chief Executive Officer, said: 'We are delighted that our late-breaking abstract on the TRIST study has been accepted for presentation at the ECCO 15-34th ESMO Congress. This provides an opportunity for us to present our data at one of the world's most well-attended and high-profile cancer conferences. There are some positive findings from our recent analyses of the TRIST study and we look forward to presenting these to the oncology community.'
-Ends-
tabasco
- 19 Aug 2009 09:37
- 1241 of 1451
Reiteration of Oxford Biomedica by Panmure Gordon to hold...I intend to!.
tabasco
- 27 Aug 2009 07:04
- 1242 of 1451
Good morning allI dont think the sp will do much on until we are told of Partnership deals for ProsavinHi-8Meland Trovaxthere are supposed to be a number of interested parties in Trovaxrumoured eightsolid news on this front needed to push the sp towards 20pgiven the current 12p+ doubled since Aprilhopefully news any minute. fingers crossed.
Toya
- 27 Aug 2009 07:25
- 1243 of 1451