Replies to post #14267 on Ariad Pharmaceuticals Inc fka ARIA

[BTH]

If that were a possibilty I would expect about $10 million worth of funding to FDA lobbyists funded by Bristol and Novartis, immediately.

Would be nice though.

[ariadndndough]

ARIAD Announces Interim Safety and Efficacy Data from Pivotal Ponatinib PACE Trial to Be Presented at Annual American Society of Hematology Meeting
~ Ponatinib to be Featured in Fourteen Presentations

~ Company to Host Investor Meeting and Webcast with Dr. Moshe Talpaz on Monday, December 12 at 7 a.m (PST)



......CAMBRIDGE, Mass.--(BUSINESS WIRE)-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA - News) today announced that interim clinical data from the fully enrolled, pivotal PACE trial of its investigational, pan-BCR-ABL inhibitor, ponatinib, will be presented at the 53rd Annual Meeting of the American Society of Hematology (ASH) being held in San Diego, December 10-13, 2011. The interim findings from the PACE trial will be featured in an oral presentation on Sunday, December 11 and also will be highlighted in an investor meeting to be webcast live from San Diego. This trial is being conducted in patients with chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant or intolerant to either nilotinib or dasatinib, two currently available CML therapies, or those who have the T315I mutation of BCR-ABL for which no current treatments are known to be effective. Thirteen additional abstracts describing clinical and non-clinical work on ponatinib will also be presented at the meeting.

Oral Presentation of Interim Data from PACE Trial

Title: Initial Findings from the PACE Trial: A Pivotal Phase 2 Study of Ponatinib in Patients with CML and Ph+ALL Resistant or Intolerant to Dasatinib or Nilotinib, or with the T315I Mutation
Oral Session: Chronic Myeloid Leukemia – Therapy: Resistance to Tyrosine Kinase Inhibitors
Date & Time: Sunday, December 11, 2011, 4:30 p.m. (PST)
Abstract No.: 109
Presenter: Jorge E. Cortes, M.D. (The University of Texas MD Anderson Cancer Center)
Location: Ballroom 20BC

Investor Meeting and Webcast

A breakfast meeting to review the interim PACE trial data with research analysts and institutional investors will feature Moshe Talpaz, M.D., Associate Director of Translational Research and Associate Chief of Hematologic Malignancies, Trotman Professor of Leukemia Research at the University of Michigan Medical Center, and members of ARIAD's management. Dr. Talpaz has been an investigator in the Phase 1 and Phase 2 trials of ponatinib. This meeting will be webcast live and can be accessed by visiting the investor relations section of the Company’s website at investor.ariad.com or dialing: 866.770.7125 (domestic) or 617.213.8066 (international) and providing the pass code 91497220.

Date: Monday, December 12, 2011

Time: 7:00 a.m. to 8:00 a.m. (PST)

Location: The Westin Gaslamp Quarter Hotel, Santa Fe Conference Room

To attend the meeting, please RSVP to [e-mail] by Wednesday, December 7, 2011.

A replay of this investor event will be available on the ARIAD website approximately three hours after the presentation and will be archived for four weeks. To ensure a timely connection to the live webcast, participants should log onto the webcast at least 15 minutes prior to the scheduled start time.

The following presentations are included among the 14 presentations at ASH to feature clinical and non-clinical data on ponatinib.

Title: Subset Analysis of Response to Treatment of Chronic Phase CML in a Phase 1 Study of Ponatinib in Refractory Hematologic Malignancies
Oral Session: Chronic Myeloid Leukemia – Therapy: New Drugs, New Procedures
Date & Time: Monday, December 12, 2011, 3:00 p.m. (PST)
Abstract No.: 602
Presenter: Jorge E. Cortes, M.D. (The University of Texas MD Anderson Cancer Center)
Location: Ballroom 20BC

Title: ATP Dependent Efflux Transporters ABCB1 and ABCG2 Are Unlikely to Impact the Efficacy, or Mediate Resistance to the Tyrosine Kinase Inhibitor, Ponatinib
Poster Session: Chronic Myeloid Leukemia – Biology and Pathophysiology, Excluding Therapy: Poster II
Date & Time: Sunday, December 11, 2011, 6:00 – 8:00 p.m. (PST)
Abstract No.: 2745
Presenter: Deborah White, Ph.D. (University of Adelaide, Australia)
Location: Hall GH

Title: Ponatinib Is Active Against the CUX1-FGFR1 Fusion Kinase and Against Imatinib Resistance Mutations of the FIP1L1-PDGFRa Fusion Kinase and of KIT
Poster Session: Myeloproliferative Syndromes: Poster III
Date & Time: Monday, December 12, 2011, 6:00 – 8:00 p.m. (PST)
Abstract No.: 3848
Presenter: Els Lierman, Ph.D. (Center for Human Genetics, Katholieke Universiteit Leuven, Belgium)
Location: Hall GH

Title: Analysis of in Vitro Activity of the Clinically-Active ABL/FLT3 Inhibitor Ponatinib (AP24534) Against AC220-Resistant FLT3-ITD Mutations
Oral Session: Molecular Pharmacology, Drug Resistance: Targeting Chemoresistant Cells and Niche
Date & Time: Tuesday, December 13, 2011, 8:45 a.m. (PST)
Abstract No.: 930
Presenter: Catherine C. Smith, M.D. (The University of California San Francisco)
Location:

[biomaven0]

head to head trial with gleevec?

I think this is the obvious way to go. The only issue is whether to do this in all patients or only Sokal high-risk patients. I'd say all patients, but stratify by Sokal score.

Basically such a trial will put you on a roughly even footing with the other 2nd-line agents. I would expect response rate and tolerability for pona to be somewhat better than the others have reported (although cross-trial comparisons are always hard), but obviously the others will always have a longer track record.

One hard question for such a trial is the dosing. I strongly suspect front line patients would be able to get away with a significantly lower dose than 45mg. That would improve tolerability, which is very significant for wide adoption. Perhaps some sort of flexi-dose schedule might work, starting patients low (perhaps 15mg) and upping the dose if they do not respond quickly.

Going head-to-head with the other 2nd-line drugs is tougher. You can't show efficacy improvements other than with a very large and long trial.

The latest research shows about 1/3 of patients will eventually fail Gleevec, so 2nd-line is a reasonable place to be. And if you can grab some of the high-risk 1st-line, so much the better.

Peter