pfizers failed tlr9 trial, page-4

Kiwoz, medical background? Nope, just another investor like you. I was familiar with Imoxine because I had been following Hybridon(Name changed to Idera) even before Solbec used their product. As long term investor in Solbec I may be able to answer some of your questions.


The original toxocoligy tests were done in Canada by Lab Pre-Clinical inc. From what I read in a June '02 Company report, it looks like they were done to the satisfaction of the FDA but not it now seems, our TGA.

"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 States Food and Drug Administration to discuss our proposed clinical and non-clinical program for the United States due to commence quarter three 2002."
"A new round of animal trials are under way in Canada aimed at completing the toxicology package required for commencement of the phase I/II human trials. Early work establishing analytical and monitoring procedures is well advanced with animal treatment expected to commence shortly. The studies with reporting are expected to be completed by the first quarter in 2003"
And his from Dec31 the same year,
"Preclinical animal trials for Coramsine™/SBP002 being conducted in Canada as a precursor to human trials were completed in December 2002. Reports covering the work are in preparation and are expected to be released to the Company shortly."
So it looks like once they are started they can be completed fairly quickly. I guess it is lab space they are waiting for. I think they will announce then as last time.
The phase 2 will be recruit 40-50 patients across Australia at 10-12 sites, then later patients to be added in the USA.
The trial will be about 2 years, but any good news to be released to the market. They said he earliest release would be 8 months into the trial.
http://www.solbec.com.au/pdfs/SolbecPresentation_23Jun2006_final.pdf
Another drug in the pipeline is DPX-01, another cancer treatment "DPX–01 is in early stage development but the initial studies carried out by the Centre for Applied Cancer Studies at the University of Western Australia, have shown very strong anti tumour activity against nine cancer types; Epidermal Carcinomas, Melanoma (met), Renal Cell Carcinoma, Colorectal Carcinoma, Uterine Cervical Carcinoma, Mesothelioma, Bladder Carcinoma and Prostate Adenocarcinoma with very strong activity against stomach cancer." But that is not yet in clinical trials.
Probably more near term promise would be from the other applications for Coramsine, against psoriasis, vetinary use, as a diagnostic tool and as a pallative treatment.
As for Pfizer, I dont think SBP will be on Big Pharmas radar till they have results back from the Phase 2. If they can get the trials on track the timing will be almost perfect for a lucrative licensing deal IMHO, BP is losing many patents over the next 4 years. An example, Pfizer will lose Lipitor."Lipitor is the world's best-selling pharmaceutical, with sales in 2005 being over $12 billion and accounts for more than one-quarter of Pfizer's total revenue." The generic manufacturers are already nipping at their heels.
http://www.ipfrontline.com/depts/article.asp?id=13863&deptid=7
http://www.forbes.com/2007/01/19/pfizer-pharma-cuts-fda-biz-cz_mh_0122pfizer.html?partner=alerts