http://www.solbec.com.au/pdfs/ASXSolbecAnnualReport2007.pdf
Coramsine’s® Cancer Project
By mid 2006 Solbec had finalised protocols for both the Malignant Melanoma and Renal Cell Carcinoma Phase II Clinical
Trials, inducted nine hospitals and delivered clinical trial material to each of these trial sites in readiness for
commencement of patient dosing. In late August 2006, Solbec was informed by the Drug Safety Evaluation branch of
the TGA that it had concerns relating to Coramsine’s® preclinical data package and investigator’s brochure.
Solbec subsequently held several discussions with the TGA to further explore their concerns and in November made the
decision to voluntarily suspend the Phase II trials pending Solbec’s development, and formal acceptance by the TGA, of
a Development Plan which addressed the TGA’s concerns. In drafting this plan Solbec secured the expertise of
independent specialist toxicologists from the United States and Australia as well as a specialist regulatory affairs
advisory firm. The draft Development Plan was completed in May 2007 and formally accepted by the TGA.
With the TGA’s acceptance of the Development Plan for Coramsine’s®, the Company now has a clearly defined
regulatory pathway.
Cash
Solbec’s capital raising in April 2007 raised $2.45M (before costs) by way of a private placement to sophisticated
investors and a rights issue available to all shareholders.
The $2.26M Australian Government’s Commercial Ready Grant, awarded to Solbec in November 2005 continues to
provide non-dilutive funding for specific aspects of Coramsine’s preclinical and clinical programme on a dollar for
dollar basis.
Solbec announced to ASX in September 2007 that it had secured access to up to $1.5M standby facility from AMB
Holdings Pty Ltd (AMB) The facility allows Solbec the right to draw down on up to $1.5M, entirely at the Company’s
discretion, at any time over the next two years.
SBP
solbec pharmaceuticals limited
