Through all this loudness everyone needs to take a step back and remember that Cvac is what holders and cancer sufferers are here for. Firstly Dubai has been left for now not due to Cvac's performance as 1 poster seemed to try and put across but regulatory restraints that was making it difficult to export cvac manufactured in Australia. Ok in reality Dubai was never a big deal that was going to make PRR huge $$ before FDA approval anyway and the focus was and now will be on moving Cvac though phase 2b/3 trials with the end point FDA approval the main focus for PRR. Cypto-1 also put on the backburner as well and Cvac the full focus on ovarian cancer but also potentially with other cancers down the track.
The newsletter out today had 1 important update that should not be overlooked. Matthew Lehman explains that they are doing an ICS study on Cvac which shows how Cvac is affecting the patients immune system. This gives PRR a better understanding of how Cvac is working biologically and if positive then PRR will be able to move forward confidently in applying Cvac to other cancers. This will be big news for PRR and should be the catalysts for a move both for the share price but also for the hope that Cvac may be useful in the fight against a wide range of cancers. Also Matthew says safety data is expected before the end of the year.
So after all the noise today about how shocking today's news was for PRR guess we are at a stage now where the focus for PRR is simply Cvac and getting through phs2b/3 trials and focusing on that with the potential to move Cvac to other cancers after this ICS data is revealed. Again PRR has gotten to where it is due to Cvac and it getting up and running again after nearly falling over in 2008. Again this was achieved by Martin Rogers successfully helping PRR survive and raising capital that PRR now has to fully fund its ongoing Cvac trials. Seems like Matthew Lehman will bring his style to PRR now and hopefully focus on the trials and achieve success not only for shareholders but for cancer sufferers. Below Matthew Lehmans talks of safety data and ICS studies in his catalysts for PRR in the near term. Today may just offer a great buying opportunity.
Q: What significant catalysts do you see coming up in the
near term?
The next year will be a very exciting time for Prima. The
CANVAS trial is up and recruiting patients. Toward the end of
2012, we expect to have all of our worldwide sites ready to
go and taking on patients.
Data from our 63-patient trial – the CAN-003 protocol – will
be coming out over the next year. There are some very
significant things about CVac we expect to learn from the
CAN-003 study and these data releases are significant
milestones for the company. First is the continued development
of CVac’s safety profile. With each new patient, we
have additional confidence that CVac is a well tolerated and
non-toxic treatment. The last patient will receive the last
dose of CVac in October. An update on safety data can then
be expected before the end of 2012. Second, we are
performing an innovative analysis called intracellular cytokine
staining (ICS). ICS will allow us to see how CVac is affecting
the patient’s immune system (i.e. the stimulation of T-cells)
after we inject CVac. The ICS techniques should confirm our
understanding of how CVac works biologically. If the ICS
data is positive, we would have increased confidence to start
looking at CVac to treat other cancer types outside of ovarian
cancer. Third, in the middle part of 2013, we will be presenting
the final results of progression-free survival – in other
words, the analysis of whether patients on CVac stayed in
remission longer than those not given CVac. Sometime later,
we will be able to present the affects of CVac on overall
survival as well. It is a bit tricky to predict the precise timing
of the data release because final analysis depends on the
number of patients that have progressed or died during the
study. But we will keep everyone very well informed in
advance of our presentation of results.
Besides the data from CVac trials in ovarian cancer, we will
be taking a critical look at how to best structure our product
portfolio and our company technologies over the coming
months.
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