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Well, that was a surprise! Now that Celator has posted successful results, what's the company worth? A call to dig into the new data and market opportunity will help us do that.Ticker(s): CPXX, JAZZ
Name: Dr Stephen Brandt - MD
Institution: Vanderbilt University
- Professor of Medicine, Professor of Cancer Biology, Professor of Cell and Developmental Biology, and Attending oncologist at Vanderbilt University Medical Center
- Extensive clinical experience in treating patients with high-risk AML, involving both standard chemotherapy and allogeneic hematopoietic stem cell transplantation
- Served as the institutional PI (and coauthor of the resulting publication) on a study of depsipeptide (Romidepsin) in relapsed/refractory AML
What is your experience treating high-risk AML and do you have any experience with VYXEOS or cytarabine and daunorubicin?
What are you impressions of the Phase 3 data released by Celator? Are there any red flags to you from what we know?
Is median overall survival the right endpoint for this trial in your opinion? Was the result of a 3.61 month improvement in favor of VYXEOS clinically meaningful to you?
What about the 12 and 24 month survival numbers? Do they seem clinically relevant to you and your patients?
The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm.
The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.
Based on these effects do you think a branded typical oncology price would be justified vs. the price of 7 +3? Why might it not be?
The side effect profile looks comparable to 7+3. Is that enough? Is there any concern that you see on the side effect profile going forward?
What could you see surprising us when the data is presented at the American Society of Clinical Oncology 2016 Annual Meeting?
The company says this about AML:
"The Company estimates that nearly 70 percent of AML patients are over the age of 60, and approximately 75 percent are intermediate or high risk. Furthermore, approximately half of those patients are considered suitable for intensive treatment. "
Which of these patient groups would be most suitable for VYXEOS?
What other late stage drugs do you know of are in development that, if successful, could compete with Vyxeos?Added By: philk
If Vyxeos is approved, how would targeted drugs in development like midostaurin that work in combination with 7+3 be affected ? Would they need to now be tested with Vyxeos?Added By: philk
What does the success of Vyxeos portend for Celator's nano-scale liposomal platform, Combiplex, regarding development of future combination therapy?Added By: philk
If Vyxeos is approved, how quickly/easily will it be adopted? How about for the AML patient subgroups where 7+3 is current standard of care but were not in the Vyxeos phase 3 trial population? Will the improved ease of administration of Vyxeos (90 minute injection - possibly as outpatient for consolidation, vs 7 day continuous infusions for 7+3) significantly improve adoption or make additional elderly patients willing to undergo harsh chemo treatment?Added By: philk
Are there any known reasons why this drug might have performed so well in secondary AML but might not do so in primary AML? In Phase 2, do you see the trial design allowing crossover for 7+3 arm as potentially confounding the results in primary AML. One of the trial investigators on the trial results conf call said they saw no reason why secondary would be different than primary and that they see CPXX's drug as replacing 7+3 as the backbone for both eventually. Do you agree? Why or why not.
Why is 7+3 the standard of care instead of high dose Daunorbuicin if the latter has good study data?Added By: edtrad
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