here it is
+++++++++++++++++++++++++
PHARMACEUTICAL PROJECTS
The first three months of this year have seen significant advances in
the development of BEC(R) and the Lawley projects. During the quarter
significant laboratory, animal and clinical studies have been
completed. The Company has set up new premises and improved
communications. We have made important progress relevant to the
eventual commercialisation of the projects. Progress has been better
than expected and the Board is pleased with results to date.
BEC(R)
Laboratory studies have continued to expand the number of cancer cell
lines that BEC(R) is active against with a further 23 tumours tested
in the USA bringing to over 60 tumours tested to date with BEC(R)
exhibiting activity against all tumours tested. Results from the USA
study have been documented in combination with clinical data from
Australia in a dissertation which has been accepted for presentation
at the worlds foremost cancer research conference (American
Association of Cancer Research) in the USA in April.
Laboratory based research has been particularly rewarding recently.
The research group has established much simplified procedures for the
separation and purification of individual components of BEC(R). This
will greatly enhance the preparation (and Registration) of
therapeutic BEC(R) formulations in the future.
The R&D team have also managed to enhance the activity of BEC(R) by
up to 300% over our original formulation with significant reduction
in irritation side effects. This reformulated product is now being
used in the animal trials and through the Special Access Scheme in
humans.
Animal studies are progressing and provide strong support to both our
human and veterinary regulatory submissions for BEC(R) and continue
to generate interesting data. Results demonstrate the safety and
efficacy of the compound in the environments tested. Studies have
also demonstrated total tumour regression (ie no histological
evidence of tumour at the and of the study) in some studies with only
mild toxicity effects. Studies have also shown that BEC(R) is
effective in slowing tumour growth and eradication of tumour when
treating both mesothelioma and melanoma intratumourally in induced
mouse models.
Solbec is focusing the clinical development of BEC(R) on the lung
cancers, malignant pleural mesothelioma and metastatic melanoma of
the lung. Mesothelioma is an asbestos related cancer of the lung that
is currently incurable. The disease takes a long time to develop or
become observable (approximately 20 to 30 years after exposure). The
average survival period after diagnosis is less than 12 months.
Whilst this disease is not prolific in society it, with the other
asbestos related cancers, will result in approximately 65,000 deaths
in Australia between now and 2020 when the disease is forecast to
peak. Developing a treatment for mesothelioma also opens up the
Orphan Drug Program for the company. This is a program that results
in a much more expeditious route to market with a reduced program of
clinical testing and a fast track through the regulatory process. Eg
the Novartis product Gleevac took 9 weeks to pass through the US FDA
where the average approval time is 29 months.
Discussions are continuing with prestigious groups to facilitate the
initiation of human clinical trials of BEC(R) here within Australia.
The trials will be centered on our target indications of malignant
pleural mesothelioma and metastatic melanoma of the lung.
Preliminary submissions have been made to the US Food and Drug
Administration and a meeting with the US regulators is scheduled for
next quarter. The Company is seeking approval from the FDA of our
preclinical project outline for the development of BEC(R) in the US.
This approval will allow the commencement of US based human trials
generating data to support our US regulatory submission.
In the meantime BEC(R) continues to be available via the TGA's
Special Access Scheme here in Australia with in excess of 30 patients
treated to date. The range of neoplastic conditions that BEC(R) has
treated continues to expand with favourable results. The data
generated through this scheme will support our other studies and
accelerate human clinical trials.
We have continued to strengthen our intellectual property portfolio
with one patent being accepted in Japan and another now in its
international prosecution phase receiving a favorable international
preliminary examination report. (since the end of the reporting
period a third patent has been lodged in Australia and the USA) We
will continue to develop further IP.
The diagnostic potential of BEC(R) has been further investigated and
is a very exciting area of research. From initial studies it appears
that we will be able to diagnose skin cancers, primary tumours and
metastatic disease using three different but simple diagnostic tests.
We are looking for a commercial partner to work with us in the
development of these tests.
OTHER PRODUCTS
Preliminary therapeutic activity studies on DPXC-01 have shown that
it is active against both Herpes Simplex types I and II (cold sores
and genital herpes) with eradication of symptoms within 48 hours.
DPX-01 is active against various cancers showing activity against 6
of the 12 tested so far.
Limited work has been carried out on these projects during the period
whist we focus on BEC(R) and the Lawley Steroids Project.
STEROID PRODUCTS
The Lawley Joint Venture continues to progress well. We have received
a preliminary assessment of the regulatory file submitted to the
Australian TGA, for Andro-feme (testosterone for women). As is usual,
for a preliminary assessment the TGA have requested further
documentation. This is currently being prepared and should lead to a
favourable outcome. We still await a response from the New Zealand
regulatory authority for the Andro-feme file submitted. Successful
outcomes of these submissions will enable sales and marketing
activities to rapidly increase the revenue stream generated by the
Lawley products.
Regulatory submissions for other Lawley products are in preparation
and are expected to be submitted to the regulatory authorities by the
end of the 2002.
GENERAL
In December the Solbec Pharmaceutical Division moved into new
premises and has built a new laboratory to expedite the developmental
process. We have employed specialist chemists to work on the
projects. The manufacturing facility is in the design phase and once
the work up of the final extraction process is completed, building of
a commercial pilot scale facility to FDA standards will commence.
The horticultural facility is in full swing with over 2000 plants now
growing and about 75% of these are now fully mature and fruiting
prolifically. Further work is being carried out to confirm the best
genotype.
www.solbec.com.au our new website has been well received with the
website having over 2000 visitors so far. The website also allows
interested people to subscribe to Solbecs' news service so that they
will be automatically emailed whenever a news article, report or
announcement is made regarding Solbec.
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