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CADOUX LIMITED — AGM Information 2007
Nov 18, 2007
64620_rns_2007-11-18_e7431864-6d97-4da1-8831-f7edd689cfcf.pdf
AGM Information
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ANNUAL GENERAL MEETING
19 November 2007
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2006/2007 IN REVIEW
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Development Plan for Coramsine[®] completed and
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approved by the Therapeutic Goods Administration – Clear path forward for Solbec to re-enter Phase II
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clinical trials
- Supplementary preclinical studies commenced
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Capital raising initiatives secured $2.45M
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Several important patents proceeded to grant
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Physician’s IND granted by the U.S. Food and Drug
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Administration
SHAREHOLDER VALUE
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Coramsine[®] has completed two Phase I trials and is
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working towards Phase II
- Efficacy and safety reported in the Phase I cancer trial
– Safety reported in the Phase I psoriasis trial
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Solbec is actively seeking out co-development partners
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for one or several of Coramsine’s[®] potential applications including:
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Cancer
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Psoriasis
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Diagnostics
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Palliation
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Animal health
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• The Company is also focused on new product acquisition/co-development initiatives which will add to current pipeline
CORAMSINE[®] OVERVIEW
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Phase I human trials complete
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Coramsine’s[®] safety confirmed
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Clinical efficacy reported
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Excellent drug safety profile
- There have been no Serious Adverse Events reported in connection with the use of Coramsine[®] in humans
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Efficacy seen in Phase I trial subjects [and anecdotally via the Special Access Scheme] is very encouraging – De-risks Coramsine’s[®] move into Phase II trials
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CLINICAL UPDATE
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Phase I trials complete � safety and preliminary efficacy reported (results presented at ASCO 2006 in Atlanta and published in the Journal of Clinical Oncology June 06)
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FDA Orphan Drug designation secured for both RCC and melanoma
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Australia: Ethics approvals received for Phase II trials. Australian Phase II trials on Voluntary Hold.
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U.S.A: Physician’s IND (single patient) opened with the FDA for RCC Patient in Long Beach California
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TGA UPDATE
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8 May 2007 Announced to market the TGA’s acceptance of Solbec’s Development Plan for Coramsine[®]
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Development Plan details a series of preclinical studies
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to supplement Coramsine’s[®] existing data package – In vitro metabolic studies (ADME)
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Protein binding studies (human, rat and dog)
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• In vitro metabolic studies in hepatocytes (human, rat and dog)
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– Toxicology � 14 day and 28 day studies
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The supplementary preclinical studies have commenced
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PHYSICIAN’S IND IN THE U.S.
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On October 16 2007 Solbec announced to market the FDA’s approval of a Physician’s IND for the treatment of a Renal Cell Carcinoma patient based in Long Beach California
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Physician’s IND Sponsored by Dr Robert Nagourney of Rational Therapeutics
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RT have had a long term association with Solbec
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Physician’s IND based on RT’s ex vivo analysis of this patient’s cancer [strong response to Coramsine[®] where other drugs had failed]
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Patient update: the patient has now completed 2 treatment cycles of Coramsine[®] therapy and is tolerating the treatment well
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SUMMARY
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Coramsine[®] Cancer Project – Encouraging Phase I efficacy results, unique mode of action and clear freedom to operate
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Coramsine[®] : significantly de-risked, advanced stage project and has a market cap of less than one tenth of the other Australian entities with similar stage projects
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Working toward resumption of Phase II trials for Coramsine[®] as soon as possible
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Solbec actively seeking licensing/co-development partners for Coramsine[®] and new projects to acquire to build pipeline
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Dr David Sparling General Manager Solbec Pharmaceuticals Ltd T: +61 8 9446 7555 M: +61 4 1772 1972 E: [email protected] www.solbec.com.au