Found some interesting analysis from a Canadian group called Yorkton Securities. (For those with the Biomira Investor's Kit, "Knowledge Industries", who did that superb valuation model, is a subsidiary of Yorkton)
First part is an analysis of the "new" Theratope vaccine and the bridging study, second part is an analysis of how this effects phase III and risk assessment.
Report by YORKTON SECURITIES INC. (CANADA). What are the potential rewards from making this change? The potential reward is improved efficacy, as shown by increased median time to disease progression and survival, and lower risk of failure in the Phase III clinical trials. In the preclinical models, the average level of antibody produced with the new formulation was one hundred times higher than with the old formulation. This effect is important only if changes in the antibody level correspond with changes in an important clinical endpoint. Phase II clinical data for breast, colorectal and ovarian cancer patients indicated that there was a correlation between the levels of anti-OSM antibody induced by the old Theratope(R) formulation and survival. An analysis of 125 patients who developed an anti-OSM response showed that high responders (greater than median antibody level) had statistically superior survival (p=0.017) compared to low responders (equal to or lower than median antibody levels). The preclinical data also showed less variation in the antibody response between individual subjects with the new formulation.
Report by YORKTON SECURITIES INC. (CANADA). What is the relative risk associated with these assumptions? There are two different stages of risk for Theratope(R). The first is the development risk - when and if Theratope(R) will be approved. There is always some risk associated with a clinical trial. The risk can be mitigated through a well-structured Phase III clinical trial, extensive discussions with the FDA before starting the trial, a disease mechanism which is understood, a mechanism of drug action which is understood, statistically significant Phase II data and a partner which has extensive experience in this process. Biomira has all of these items. The only cautionary notes are the change in formulation and the change in clinical trial structure from Phase II to Phase III. As discussed earlier, we believe that the formulation change carries very little risk from a safety perspective and tremendous upside potential from an efficacy perspective. The usual concerns with a change in clinical trial structure are a wider variation in the patient population and a larger than expected placebo benefit. In this case, the Phase III patient population is both better defined and expected to respond better to Theratope(R) than the Phase II patient population. Placebo effects are not seen in cancer clinical trials.
Nicely explained.
Looking forward to those bridging study results at the ASCO!
SM |
