Pixantrone: Cardiac Issues Yes or No?
April 15, 2009 at 6:51 pm EST | Tags: CEOs & Management, Filings & Approvals, Gossip & Rumors
Yesterday, Cell Therapeutics (CTIC) initiated a rolling NDA for Pixantrone (Pix). The company announced that they expect to complete the submission by the end of this quarter so they will definitely beat their previous guidance of a June 2009 submission.
Two big questions remain:
Will Novartis (NVS) execute its option to license Pix?
How serious are the cardiac issues?
Regarding #2, Xconomy first reported the cardiac events when the Pix data came out, but not much was made of it in the press releases and news. In fact, when Xconomy wrote this post, CTIC CEO James Bianco commented on the post and said this about the potential cardiac sequelae:
Such cardiac events could be results of tumor invasion of the heart which is quite common in lymphoma, as a consequence of infections with hypotension which are quite common during treatment of late stage disease or events unrelated such as myocardial infarctions or arrhythmias. All fall under what would be classified as a serious cardiac adverse events even though the event is not a direct effect of the drug on the heart but rather results from preexisting diseases or unrelated untoward events. Once the full data is presented at ASCO, perhaps you will have a better understanding of why we think your interpretation of these few events is highly misleading.
Yesterday, Reuters and all the major news outlets did state that:
The pixantrone patients had a higher incidence of leucopenia and neutropenia and numerically more severe cardiac events (5 vs. 2) with only 1 considered related to the study drug by the investigator.
So what gives? Should investors be concerned? The full data has not been presented, but will be at ASCO. Is Reuters wrong or is everyone just reading misleading information? What’s going on?
With regards to #1, our thoughts are that NVS has no reason to rush, especially since there’s no option timeline. Wait for the NDA filing acceptance, at least, or better yet, come in on approval and re-negotiate the high royalty rumors that have been floating around.
Ahhh, ASCO, you tell us so much 
Image from all over the damn web
![[Loading...]](http://www.iguanabio.com/wp-content/themes/IguanaBio/images/ajax-loader.gif){kind=small}
1)SERIAL CARDIAC FUNCTION EVALUATION, A DIRECT MEASUREMENT OF THE DRUG’S POTENTIAL EFFECT ON THE HEART TISSUE WAS NO DIFFEREENT THAN STANDARD CHEMOTHERAPY. CARDIAC ADVERSE EVENTS IS A CLASSIFICATION THAT REFERS TO ANY CONDITION WHICH MAY LEAD TO A FAST HEART RATE, LOW BLOOD PRESSURE, ETC, WHETHER IT IS RELATED TO THE DRUG’S DIRECT DAMAGE TO THE HEART OR NOT. ONLY 1 CARDIAC ADVERSE EVENT WAS REPORTED IN THE TRIAL BELIEVED TO BE DUE TO THE EFFECT OF THE DRUG DESPITE THE FACT THAT ALL PATIENTS HAD AN AVERAGE OF MAXIMUM DOESES OF PRIOR ANTHRACYCLINE THERAPY—AN UNPRECENDENTED RESULT.
2) THE NOVARTIS OPTION ON PIX REMIANS INTACT, IT IS ALSO TRUE THAT SINCE CTI RELEASED POSITIVE PHASE III RESULTS, OTHER COMPANIES HAVE APPROACHED THE COMPANY ABOUT A CO-PARTNERSHIP.
Dan Eramian- Did CTI receive the $3.5M from Spectrum that was reported to be received on April 15th? Thank you, M
Um, Dan Eramian doesn’t know how to take his comp off ALLCAPS?
Weird.
ciao Dan..
(
io avere investito / … preso tranvata… 1 one millions $$ in cioffy Cell… quanno pensi ke me ridai….
)
by
salutame a Jonny…..
When is ASCO?