Hep C Phase 1b/2a results soon
Biotron (BIT.AX)
MarketCap: 11,4 MioA$ ( 8,3 MioUS$)
Price : 0,09 A$
Your support of your Company at this time is critical to:
Completion of the Phase Ib/IIa Hepatitis C virus ('HCV') clinical trial.
Ensuring that commercialisation negotiations following the completion of the HCV clinical trial are
undertaken with the Company in a position of financial security.
The Directors encourage all eligible shareholders to support the Company and take advantage of this
opportunity to acquire Biotron shares without brokerage or other transaction costs and at a discount of
approximately 15% to the weighted average share price for the five business days preceding the date that the
SPP was announced.
Introduction
Biotron has achieved great success in its antiviral drug development program to date, culminating in its lead
investigation drug, BIT225, currently being trialed in HCV positive patients.
This human trial will provide the first evidence of the efficacy (the antiviral effectiveness) of BIT225 in HCV
positive patients. The successful completion of this human trial will represent the most significant milestone
achievement for the Company to date and is the result of many years of painstaking work.
The vast majority of potential drugs never reach this stage of development and the significance of BIT225
reaching this stage of development and the work completed to get BIT225 to this stage should not be
underestimated.
Following a successful completion of this human trial, the Company will focus its efforts on completing a
commercial deal with a pharmaceutical company to continue the development of BIT225 to a marketable drug.
Discussions with a number of pharmaceutical companies have been ongoing for some time and BIT225 is well
known in the drug development industry. The Directors are keen to ensure that completion of commercial deal
is not hurried or compromised by the Company's short term financial constraints. The success of a commercial
deal will be assisted by the support of shareholders at this critical time.
History
In late 2007, the Company completed a successful Phase I, first-in-human study of BIT225 in healthy
volunteers.
Following this success, the first half of 2008 was spent designing the Phase Ib/IIa trial of BIT225 in patients
infected with HCV – the first study of the drug in a patient population.
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In consultation with experts in the field, the trial design was finalised, and documentation prepared for obligatory
ethics and regulatory submissions. Approval for commencement of the Phase Ib/IIa trial was given in August
2008. The trial, code-named BIT225-003, is a placebo-controlled, randomised study of the safety,
pharmacokinetics and antiviral activity of BIT225 in patients with HCV infection designed to assess the safety
and tolerability of BIT225, to assess the pharmacokinetics of BIT225 and to assess the antiviral efficacy of
BIT225 in these patients.
Eighteen patients are being randomly assigned to receive one of two dose levels of BIT225 or placebo. The
trial is being conducted at two trial sites, based in Sydney and Brisbane, to expedite the trial by maximising the
eligible patient recruitment rate.
Patient recruitment was initially slower than expected, however, modifications to the trial which have been made
with ethics and regulatory approvals have resulted in a significant improvement in patient recruitment rates. To
date, a total of 6 patients have successfully completed the trial and a further 6 patients are currently in a pre-trial
process and are expected to be dosed within the next two weeks, subject to passing the pre-trial eligibility
criteria.
Patient recruitment for the trial is expected to be completed by the end of March 2009.
Due to the design of the trial, results are not available until the end of the study. The trial is blinded, with
patients receiving one of two dose levels of BIT225 or placebo and the study will only be unblinded at the
conclusion of the trial.
While data from the patients dosed to date is incomplete and unknown to the Company, there have been no
reported serious adverse events and the trial continues. It is truly a case of 'no news is good news'.
Financial History
The Company has been strictly managed financially, having raised a total of only $19.1 million from
shareholders and only seeking shareholder support on three occasions since its initial public offering in
December 2000.
At the time of the last capital raising in late 2007, Biotron anticipated leveraging shareholder funds, as it had
done so before, by accessing matching funding for the Phase Ib/IIa trial through the Federal Government’s
Commercial Ready grant program. Regrettably and without any indication to do so, the Federal Government
cancelled the Commercial Ready grant program in the May 2008 Federal budget, right at the time that Biotron
was finalising protocols. Biotron had not anticipated having to fully fund the trial, so the cancellation of the grant
program has had a significant adverse impact on the financial position of the Company.
The cancellation of the Commercial Ready grant program caused the Company to hold the commencement of a
second Phase Ib/IIa clinical trial for the treatment of HIV and focus the Company's financial resources on the
HCV clinical trial. The HIV clinical trial, which has finalised protocols ready for submission for ethical and
regulatory approvals, could be commenced quickly with sufficient financial resources.
The Company is focused on achieving a successful outcome from the HCV trial, and has been progressing
discussions with potential pharmaceutical companies in anticipation of finalising a deal once the trial has been
completed. The trial has been designed to benefit shareholders through significantly increasing the value of
Biotron in the market and to its future pharmaceutical company partners.
It is critical that the Company be sufficiently funded to enable full analysis and review of the data, and to enable
negotiation of a partnership/licensing deal with an international pharmaceutical company at the conclusion of
the trial. To this end, the Directors believe it is prudent at this time to raise additional capital to ensure that
maximal value can be extracted from the trial for shareholder value creation. Being in a strong financial position
will put Biotron in a stronger negotiating position with potential partners. The Directors also believe it
appropriate to offer existing eligible shareholders the opportunity to participate in this exciting time of the
Company's development by way of the SPP.
Purpose of the Capital Raising
The funds raised by the SPP will be used to support the Company's ongoing operational costs, including
funding the completion of the Phase Ib/IIa HCV clinical trial and ensuring the Company is in a position to
complete negotiation of a licensing deal.
