Oxford
BioMedica Annual General Meeting 2004
At Oxford
BioMedica’s Annual General Meeting, held today in
London, all resolutions were duly passed. Following the
meeting, the Company’s CEO, Professor Alan Kingsman
made the following statement:
“The
first quarter of 2004 has built on the product development
and commercial progress described in the 2003 Annual Report.
There have been several encouraging developments since
the full year results.
For the
TroVax® cancer immunotherapy
product, the Phase II trials programme is advancing as planned.
Recruitment
has been expanded from fifteen to twenty patients in the
first Phase II trial, alongside chemotherapy agents 5-fluorouracil
and irinotecan in colorectal cancer. Data from this trial
are expected around mid-2004. The second trial, with chemotherapy
agents 5-fluorouracil and oxaliplatin in colorectal cancer,
is similarly progressing with data expected in H2 2004. Three
additional Phase II trials are on schedule to start in 2004.
The Cancer Research UK funded trial in colorectal cancer
is expected to start recruitment shortly. The first US trial
with TroVax, which is in metastatic renal cancer, is on track
to start in Q3 2004 or earlier and the US Southwest Oncology
Group funded trial in late stage breast cancer is similarly
planned for Q3 2004.
The manufacturing
scale-up of TroVax is moving ahead. 12,000 doses of TroVax
have now been successfully
produced by a
major biologicals manufacturer. The Company is conducting
small bridging studies with this material, which will otherwise
be used for Phase III trials.
Planning
for initial Phase III trials in 2005 is ongoing with three
main options under
consideration: TroVax with
chemotherapy in colorectal cancer, based on the current
Phase II studies; TroVax in colorectal cancer post chemotherapy,
based on the evaluation of the Phase I/II trial data (following
the encouraging survival analysis reported in March 2004);
and TroVax in renal cancer, based on the initial Phase
II
trial data due to emerge from the US study in early 2005.
The Company is in discussion with potential development
partners and definitive plans for Phase III trials depend
on the outcome
of these discussions.
The MetXia® Phase II trial in patients
with pancreatic cancer is underway, slightly ahead of schedule.
Initial results
from the first stage of the trial are expected in Q4 2004.
ProSavin® for Parkinson’s disease has generated
additional, exciting preclinical data and has attracted significant
interest from potential partners. As part of the process
of moving ProSavin into clinical trials, a pre-submission
meeting is due to be held with the UK Gene Therapy Advisory
Committee (GTAC) on 21 April to discuss regulatory plans
for this innovative product. As set out in the 2003 Annual
Report, the Company expects to start clinical development
with ProSavin by the end of 2004.
During
this first quarter initial data have been obtained showing
that RetinoStat® is
efficacious in an industry standard preclinical model of
age-related macular degeneration.
The full preclinical efficacy data pack is on schedule for
completion around the middle of the year.
Preclinical
development of MoNuDin™ for the treatment
of motor neuron disease and SMN-1G for spinal muscular atrophy
is progressing according to plan. Today the Company is announcing
that its Innurex® programme for nerve regeneration in
spinal cord injury has been awarded $150,000 from the Christopher
Reeve Paralysis Foundation. The Company has recently generated
encouraging preclinical data with Innurex demonstrating aspects
of nerve repair in models of stretch injury. As stated in
the 2003 Annual Report, data that show restoration of limb
function following injury is expected around mid-2004.
Following
the signing of the LentiVector® research license
with Merck & Co. in February 2004, additional licensing
opportunities for the technology have emerged. Discussions
have been initiated with four new potential licensees. Two
of these are in the field of transgenics.
On 29
March 2004, the Company reported that the UK Department
of Health had
awarded the Company a grant of £500,000
to develop its LentiVector technology for use in the treatment
of haemophilia A, a condition caused by a defective gene
for Factor VIII, a key component of the mechanism for forming
blood clots.
The Company
has continued to make clinical and technical progress and
has achieved further product endorsement
from
independent funding organisations. The award of the Christopher
Reeve grant means that Oxford BioMedica now has five of
its seven products supported by independent research or
charitable
organisations. In addition, a new product opportunity in
the field of haemophilia is being funded entirely by the
Department of Health. This level of backing of Oxford BioMedica’s
products and technologies provides credibility and added
value for potential partners while at the same time reducing
the Company’s cash consumption. This is all achieved
without any loss of commercial rights.
In terms
of financials, Oxford BioMedica has made a strong start
to the year. Based
on unaudited management accounts,
the cash balance was £29.3 million at 31 March 2004
(31 March 2003: £18.2 million), which is better than
budget. The cash outflow for the three months to 31 March
2004 was £2.6 million (Q1 2003: £2.8 million).
Looking forward, the Company is on track to stay within its
financial forecasts. The Company has sufficient cash resources
to 2007 without taking into account expectations for increased
revenue.
Overall
2004 is set to be an exciting year”.
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