and like big pictures, tell us about your vision. Tell us how you like Raj's leadership, company performance, goals accomplished, deserved bonuses etc. Do not hesitate. Fulfill your dream.
You know what I mean. This trial (enrollment) was stared almost 9 years ago and 7 years ago enrollment was completed. I do not pretend anything. "This trial does not matter" if you are not curious enough. I found it interesting and posted it here. And what I posted is true. Have a problem with that?
No, I really follow Spectrum's drugs in development. I found inconsistency and asked a question. Your answer is wrong as always. It is not "based on date first received". "First received" was nine years ago. And do not advise me what should I focus on. It is none of your business. Especially when you don't understand what is important and what is not.
Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease, NCT00364676 (phase 1)
Primary completion date moved from Dec 2014 to Jun 2015. Wonder why it was not terminated.
I am not an expert and therefore recommend you to read an article “Marker Lesion Experiments in Bladder Cancer—What Have We Learned?” J. Urol. 2010, 1678-1685
1. “According to phrase 18 of the World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, the 2 components that must be present in every experiment using human subjects are safety and an opportunity to benefit from participation in the study. Accordingly many institutional review board committees find it difficult to approve studies in which a malignant tumor is deliberately left unresected.”
2. It seems like ML approach in urology has been used only for phase 1/2 studies and mostly (only) in Europe.
3. Very few patients could be qualified for ML studies and I am not sure they will agree to have tumors not removed from their bladders.
4. ML is an informative type of study if you want to know response rates, actually only CRs, but not time for tumor recurrence. It is my opinion.
I don’t want to argue, only give you one example. I was investing in company which run phase 3 trial with two doses of the drug. It turned out that higher dose did not work but lower dose was perfectly OK. What FDA said? You need to run a new trial with lower dose only.
With Apaziquone, pre-specified primary endpoint of the trial was not met. 6, 12, and 18 months data is just a post hoc analysis. It can help to formulate a new hypothesis which will need to be proved in a new trial. I don’t know any precedent where FDA accepted post-hoc efficacy data for approval. Sorry, forgot that I don’t want to argue.
This analyst is worse than fortune tellers
"Benjamin has a -9.3% average return when recommending SPPI, and is ranked #3036 out of 3602 analysts."
"which start investors thinking about the possibilities"
One possibility with present management is that they could announce enrollment but will not enroll as they did with Marqibo and most likely with Apaziquone multi-instillation trial. Everything will look OK for a while.
You are wrong.
"The threonine-790 to methionine (T790M) point mutation is found in approximately 50% of all patients at the time of acquired resistance to EGFR TKI therapy"
Read Oncogene. 2009 August ; 28(Suppl 1): S24–S31.
I recommend to read an article published in Pharmacological Research 87 (2014) 42–59
Name Target PubChem CID Cancer indications
FDA-approved ErbB kinase inhibitors
Afatinib ErbB1 10184653 NSCLC
Erlotinib ErbB1 176870 NSCLC
Gefitinib ErbB1 123631 NSCLC
Lapatinib ErbB1/2 208908 Breast
ErbB kinase inhibitors in clinical trials
AZD-9291 ErbB1 Not assigned NSCLC
BMS-599626 ErbB1/2/4 10437018 Glioma
Canertinib ErbB1/2 156413 NSCLC/breast
Dacomitinib ErbB1/2/4 11511120 NSCLC/gastric/head and neck/glioma
Icotinib ErbB1 44609731 NSCLC
Neratinib ErbB1/2 9915743 Breast/NSCLC
Poziotinib ErbB1/2/4 25127713 NSCLC/breast/gastric
TAK-285 ErbB1/2 11620908 Advanced solid tumors
Vandetanib ErbB1/VEGFR/RET 3081361 Thyroid/NSCLC/head and neck
WZ4002 ErbB1 44607530 NSCLC
This list is not complete. It does not include some most promising third generation TKIs.
Listen to their 1astQ CC:
"Our focus will be on a fast-to-market development strategy, capitalizing on the robust activity identified in breast cancer patients who failed previous HER2-directed therapies and those with the specific receptor mutations."
Based on data presented at ASCO, we know that drug has no effect on specific receptor mutations which is T790M. This mutation is a major cause of resistance to first and second generation TKIs. Learn more about neratinib. Chemically not much different from poziotinib, way ahead of poziotinib in clinical trials, showed very similar preclinical profile but could not inhibit T790M receptor in patients. It was a good chance for poziotinib to differentiate. Did not work. And guess what? It was tested in "breast cancer patients who failed previous HER2-directed therapies and those with the specific receptor mutations".
"Obvious clinical evidence suggesting that poziotinib may overcome acquired resistance secondary to EGFR T790M mutation was not captured in this study"
Now you can forget about poziotinib. It won't be better than neratinib.
Yes, their strategy is clear. To buy cheap shares, to replace failed CEO and to give the company a fresh start or to sell it. Both scenarios are good for them and for shareholders. For some biotech companies, just recruiting a new CEO with focused business plan is enough to start long term growth. Raj had his chance, but he blew it.