AstraZeneca has suffered a setback in its oncology drug development strategy. The
pharma giant reported that the closely watched prostate cancer therapy zibotentan
failed a late-stage trial. At a minimum, the Phase III failure is forcing
AstraZeneca to put any plans on filing for regulatory approval on hold. The therapy
is in two other late-stage trials as well.
TheStreet's Adam Feuerstein had been keeping a watchful eye on the drug's progress,
noting its potential to go head-to-head with Dendreon's newly approved Provenge.
Zibotentan would have offered advanced hormone refractory prostate cancer patients
an oral alternative to Provenge. But that threat diminished significantly with the
news of the Phase III data.
"Based on this study result, AstraZeneca plans no regulatory submissions for
zibotentan at this time," the company reported in a terse statement. The full data
will be displayed sometime next year.
Earlier this month researchers reported that zibotentan's survival benefit in a
Phase II study was actually narrower than had been first reported, dropping below
the level of statistical significance. AstraZeneca has also been hit with trial
failures for Recentin in colon cancer and Vandetanib in non-small cell lung cancer.
AstraZeneca, however, has filed for approval of Vandetanib and has five other cancer
programs in mid-stage development.
If you cannot hold this (or participate in panics like this or at least have the ability not to flinch) for the next 18-24m, OGXI is not for you. The reason I think these make good long term investments (aka dead money) is because, as opposed to other classical long term investments, risks/panics like the current one exist. Just remind yourself in 2.5yrs what your expected market cap of such a company should be.
The update from the CC was not what i was looking for. Did it satisfy you? How can you not mind the plundge in the PPS! I see it in the SINGLE DIGITS losing money is not why i am in OGXI for. Also buying it cheaper and cheaper does not make it a winner 3 years from now ONLY DEAD MONEY...
I dont think Abiraterone, Zibotentan, Sunitinib etc., are/were true competitors to OGX-011. A competitor would be a drug that would unseat docetaxel or have the same mechanism as ogx-011. I still cant find any trial that goes head-to-head against docetaxel in CRPC and I'm not aware of any latter.
However, here is my list of phase 3 trials and completion dates (based on completion dates on clinicaltrials.gov) in this space.
4/11 Zibotentan http://www.clinicaltrials.gov/ct2/show/NCT00617669
4/11 Abiraterone http://www.clinicaltrials.gov/ct2/show/NCT00887198
2/12 Zibotentan http://www.clinicaltrials.gov/ct2/show/NCT00626548
6/12 Aflibercept http://www.clinicaltrials.gov/ct2/show/NCT00519285
12/12 dasatinib http://www.clinicaltrials.gov/ct2/show/NCT00744497
10/13 Orteronel http://www.clinicaltrials.gov/ct2/show/NCT01193257
11/13 Lenalidomide http://www.clinicaltrials.gov/ct2/show/NCT00988208
*12/13 OGX-011 http://www.clinicaltrials.gov/ct2/show/NCT01188187
3/14 Atrasentan http://www.clinicaltrials.gov/ct2/show/NCT00134056
2/15 Ipilimumab http://www.clinicaltrials.gov/ct2/show/NCT01057810
?/1? MDV3100 ?? (not up yet)
9/10 Zibotentan failed http://www.clinicaltrials.gov/ct2/show/NCT00554229
10/10 Abiraterone waiting for second line results
12/12 Ipilimumab second line http://www.clinicaltrials.gov/ct2/show/NCT00861614
10/07 Atrasentan failed other PC studies
?/1? MDV3100 second line http://www.clinicaltrials.gov/ct2/show/NCT00974311
9/12 OGX-011 second line http://clinicaltrials.gov/ct2/show/NCT01083615
My definition of a competitor or potential competitor is any drug that can take assets that could have been used for the product you're watching and divert them into other products. If these other products didn't exist you'd have the potential for more revenue for your desired product. For example, Diovan is a competitor to Tekturna even though they are in different classes and sold by the same company as they both treat the same problem...that being high blood pressure. If one of the other didn't exist some of that money would be directed toward your desired product. t
MDVN just announced the first line MDV3100 trial. http://investors.medivation.com/releasedetail.cfm?ReleaseID=512202
clinicaltrials still does not show it though. My guess is that patients who used keto will probably be excluded from the study but I'm really curious about the secret formula that they will use to prevent (placebo) patients to use (off-label) abiraterone after failing this study and/or after failing chemo.
I guess that's why the study needs a whopping 1700 patients.