They have not been sitting on their hands.
Recent update........
It has now been nearly twelve months since Solbec changed its name
from Britannia Gold NL to Solbec Pharmaceuticals Ltd and its
direction to pharmaceutical R&D. It has been an eventful period. In
this time we have:
* Completed five animal studies.
* Treated over thirty patients with BEC(R) under the Specials Access
Scheme.
* Completed a cohort of non-clinical studies.
* Lodged patents and had a patent approved in Japan.
* Shown BEC(R) to be active in over 100 tumour lines.
* Presented BEC(R) scientific data over 15,000 researchers at the
Worlds largest cancer conference in America.
* Horticultural facility developed and over 2000 plants under
cultivation.
* Moved premises.
* Established and commissioned new laboratory facilities.
* Launched the Web site.
* Met with all key regulatory authorities in USA, Europe, UK and
Australia.
* Lodged Regulatory filings in Australia and New Zealand for Lawley's
"Androfeme" testosterone cream.
* Initiated three phase II/III clinical trials for Lawley products.
* Completed one phase III clinical trial for Lawley products.
* Determined therapeutic activity of DPXC against cancer cell lines.
* Determined activity of DPX-01 against Herpes Simplex.
The above summary is an outline only of the work undertaken and much
additional development work is in progress.
BEC(R) UP-DATE
In April, the Managing Director and Regulatory and Clinical Manager,
accompanied by our US Regulatory Specialist and a representative of
our Canadian toxicology Group met with The United Dates Food and Drug
Administration to discuss our proposed clinical and non-clinical
program for the United States due to commence quarter three 2002.
Solbec's proposal was very well received and generated positive
discussions between Solbec and the FDA. It was also confirmed that
BEC(R) would go through the fast track assessment program. We will
now lodge documentation with the FDA seeking to have BEC(R)
designated as an orphan drug. Solbec was very pleased with the
outcomes achieved.
In the first week of April, the largest Cancer Research Conference in
the World was held in San Francisco, Solbec was delighted that a
presentation on BEC(R) made the first day agenda of the conference.
The presentation was given by Dr Robert Nagourney, a well respected
Clinical Oncologist from California. Dr Nagourney has been working on
BEC(R) for approximately nine months. During this time he has tested
over 68 tumour types. The presentation detailed the results
generated.
The highlights of the Nagourney presentation were:
* BEC(R) was effective against all 68 tumours tested.
* BEC(R) target tumours include melanoma, sarcoma, breast, and
gastric intestinal tumours.
* BEC(R) activity appears to correlate closely with taxol (worlds
largest selling anti cancer drug ($3.0 billion/year).
* BEC(R) potentates the activity of me other chemotherapeutic drugs
by up to 32%.
The presentation was well received and BEC(R) was introduced to an
audience of over 15,000 researchers.
The Managing Director has met with and is holding discussions with
manufacturers in the US and Europe with regard to the manufacturing
of BEC(R) formulations for international markets. These discussions
are in the early stage.
Solbec's Pharmaceuticals division moved to new premises in Osborne
Park, Western Australia in January 2002. The premises were chosen to
allow the development of a laboratory and manufacturing facility for
BEC(R) extraction.
The laboratory is now equipped and fully operational with
commissioning and validation complete. We have now employed three
specialist chemists engaged in formulation, stability trials, process
development and BEC(R) purification. The laboratory and staff will
allow us to expediate our development program. Manufacturing of BEC-2S
has continued in the laboratory. Work carried out by Curtin University
has successfully developed a large scale extraction - purification
process for BEC(R) which our chemists are now validating at Solbec's
premises.
Scale up will allow commercial quantities of BEC-2S to be manufactured
Solbec have a modern horticultural facility where propagation and
cultivation of the selected plant species is undertaken. The facility
south of Perth currently has over 2000 mature plants and over 1,000
seedlings in various stages of maturity. We have a second propagation
facility north of Perth to ensure constant supply of plant material
should there be any adverse event at either facility. Further
facilities are planned as the need arises.
Results for the animal studies carries out at Murdoch University have
confirmed the efficacy and safety of BEC(R) in melanoma and
mesothelioma models. Mesothelioma is an incurable asbestos related
lung cancer. The results Solbec has achieved in mouse studies are very
promising with independent reports stating that "most researchers
would be excited with 1% remission of disease", whilst Solbec
achieved 17% remission.
Pre-clinical work required by the US FDA in order to commence human
trials in the US, has been identified and a Canadian group has been
commissioned to undertake the program. Work is expected to begin
Quarter three 2002.
Phase I/II clinical trials are being planned in Australia and will be
carried out to the stringent FDA standards. We are currently in
discussions with a prestigious group of hospitals to undertake these
studies. It is proposed that these trials will be completed by
December 2002 and phase II studies in the US will be under way early
2003.
The potential for Solbec to capitalise on BEC(R) was further expanded
with another provisional patent application in Australia and the USA,
lodged in February, and with the approval of an existing patent in
Japan. Further patents are in development and we hope to have these
lodged with the Australian and US authorities in the near future.
The patent lodged in February will protect our IP in relation to the
diagnostic potential of the drug as well as its use as a therapeutic.
In the laboratory we have shown that we can identify and visualise
cancer cells using this technology, we are now looking for partners
to complete the development. Solbec has been approached by a number
of companies interested in working with us on this project.
In an effort to keep the public and shareholders informed of the
company and our progress, in December 2001 we initiated our web site
www.solbec.com.au (http://www.solbec.com.au/). The web site has had
in excess of 2500 visitors and provides a wealth of information about
the company. The web site also allows interested people to subscribe
free of charge to our news service, so that each subscriber will be
e-mailed whenever a news article, report or ASX announcement is made
regarding Solbec. This ensures real time up to date information for
the shareholder or subscriber.
In the past six months Solbec has received a large amount of media
coverage including:
* ABC News
* National Nine News
* ABC radio business hour
* WA Business News
* Sunday Times x 3
* Sydney Morning Herald
* Bio Medoz
* West Australian
* Huntleys Small Companies Guide
* Bioshares
* Real Estate Show
* Stock to Watch (Sanford)
* CNBC
* Melbourne Age
The Directors are aware of the benefits of good media coverage and
will continue to elicit publicity at the appropriate time. We have
been keeping stockbrokers updated on announcements and informed of our
progress. Excellent responses have been received from many of the key
firms in Biotech. Many broking firms will not recommend stock to
their clients until they have completed a due diligence study and
compiled their own research report. We are aware of this and are
working with a number of the firms to facilitate this process. We
have recently commissioned an independent review of Solbec's
operations and science. This review was very positive and will be
forwarded to broking firms with the hope it will assist them in their
own assessment of the Company. The Managing Director will continue
meeting with Investment Advisors to inform them of Solbec's progress
and potential.
STEROID PRODUCTS (LAWLEY PHARMACEUTICALS JV)
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,
the TGA have requested further documentation. This has been prepared
and submitted and should expedite the approval process outcome. We
have also received a response from the New Zealand regulatory
authority for the Andro-Feme file submitted and data is currently
being prepared to meet their requirements. 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 2002.
CASH POSITION
As at 30 April 2002 the Company held $1.4M cash on deposit. The
Company also has holdings in ASX listed entities currently value at
ca$2.4M. Included in these holdings are 8.5 million shares (HRK) and
2.75 million options (HRKO) in Heartlink Limited. Heartlink Ltd
recently acquired the Travelworld, Traveland and Jetset travel
franchise groups and following a change in name to Jetset Travelworld
Ltd and capital raising is expected to relist on ASX around 30 May
2002. Solbec provided loan funds of $1.0 Million to assist Heartlink
in the abovementioned acquisitions and is entitled to convert the
loan funds to shares and (1:2) options in Heartlink at $0.20 per
share.
The investment was made to return a direct dividend to Solbec and
also to enhance the value of the significant equity in Heartlink held
by Intermin Resources Ltd (IRC) (currently 26% of the issued capital
of HRK). Solbec holds 12.35 million shares or 13.2% of the issued
capital of IRC. This holding is currently valued at ca$0.74 million.
In addition to the abovementioned current assets, the Company
believes that notwithstanding the withdrawal from MIM from the
Jervois Project, the project has a significant cash value. Solbec is
currently negotiating with a number of parties to realize this value.
Should these negotiations conclude successfully the cash position of
the Company would be further enhanced.
MINERAL PROJECTS
Activities on the Company's mineral projects are gradually being
phased out as joint ventures are terminated or tenements are not
renewed.
JERVOIS PROJECT - MIM JOINT VENTURE
Exploration by MIM at the Jervois Project is being wound down
following disappointing results in recent drilling at this project.
It would appear that while early results from MIM were very
encouraging and substantial copper resources exist, the Jervois
Project does not provide the size/grade parameters which meet MIM
investment criteria. The result is disappointing for the Company and
MIM who have expended over $2.5M on this project since commencement
of the Joint Venture.
The Company has been notified by MIM of its withdrawal from the
project as at 28/05/2002. The Company has had numerous enquiries from
parties seeking to acquire the project or to continue exploration in
joint venture with the Company. These enquiries are currently being
considered.
POTASH PROJECTS
The Company holds a number of mining tenements which have potential to
produce potash. These include the Chandler Alunite Project (option to
acquire), the Gingin Dandaragan Glauconite project and the Yaringa
Potash project.
Exploration and metallurgical testwork undertaken on these projects
over the past two years has been very encouraging and indicates
excellent potential for viable potash recovery from resources held.
The Company is seeking a well funded resource company to acquire or
fund development of these projects.
OTHER PROSPECTS
Exploration activities on the Company's other (gold) prospects have
been restricted to minimum expenditure input requirements. Farm in
partners are being sought for these projects.
SUMMARY
Overall the Pharmaceutical project continues to provide exciting and
encouraging results. The Company is well on track and on budget to
achieve its long term goals of registration of BEC(R) and steroid
products in world markets. The mineral assets are being packaged into
marketable parcels to assist in the divestment of those assets. The
Directors and Management of Solbec are pleased with the progress of
the Company to date.
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