Search found 529 matches

by Fishermangents
Mon Feb 22, 2016 5:23 pm
Forum: ImetelChat
Topic: Geron - Imetelstat achievements since 2014
Replies: 14
Views: 7252

Geron - Imetelstat achievements since 2014

I revisited an earlier overview from YMB of Geron's state of play since 2nd part of 2014. I am reposting it here, including some new facts. (version 5, updated 15 July 2016) on imetelstat: 1. partial clinical hold lifted; 2. 3 x ODD status: for MF in the US and EU, for MDS in the US 4. JnJ deal with...
by Fishermangents
Mon Feb 22, 2016 3:59 pm
Forum: ImetelChat
Topic: Time Line
Replies: 3
Views: 1562

Re: Time Line

Maybe a first atempt to set up a timeline based on events/milestones: Clinical: Imbark & Imerge: early readouts CT1951: Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure); Can we expect other milestones from this study? AML: start clinical combi-tr...
by Fishermangents
Sun Feb 21, 2016 11:18 am
Forum: ImetelChat
Topic: Time Line
Replies: 3
Views: 1562

Re: Time Line

btw: irish is here, as well as known experts such as Phil, Greg BioPearl and Hoosier. Good ingredients to start a good discussion, I would say....
by Fishermangents
Sun Feb 21, 2016 11:14 am
Forum: ImetelChat
Topic: Time Line
Replies: 3
Views: 1562

Re: Time Line

Hi idomer, welcome here! Good suggestion: any form serious discussion is highly appreciated. Speculating about timelines is especially interesting, because for that we need to try to see the unkowns based on what we do know. So let's start the discussion and see how much we can get to the table! The...
by Fishermangents
Fri Feb 19, 2016 1:58 pm
Forum: ImetelChat
Topic: More PreMF patients within ET cohorts than currently diagnosed
Replies: 2
Views: 1798

More PreMF patients within ET cohorts than currently diagnosed

It already has been said at other occasions: ET is not so 'innocent' as we may think. This article suggests that there are significantly more PreMF cases amongst ET diagnosed patients than we currently acknowledge. That means that imetelstat may very well play a life saving role for a significant su...
by Fishermangents
Sun Feb 14, 2016 8:01 pm
Forum: ImetelChat
Topic: Dr. Raajit Rampal speaks about imetelstat
Replies: 0
Views: 1780

Dr. Raajit Rampal speaks about imetelstat

(from September 2015; I didn't see it before) Women and MPN Conference, San Diego 11-12 September 2015 Genetics and Targeted Therapy of MPN, by Dr. Raajit Rampal MD At 23:55 of the video he speaks about imetelsat, its mechanism and the promising results as reported by Tefferi, Baerlocher and NEJM. l...
by Fishermangents
Sat Feb 13, 2016 11:32 pm
Forum: ImetelChat
Topic: On another note...
Replies: 8
Views: 4640

Re: On another note...

I see...Tx
by Fishermangents
Sat Feb 13, 2016 11:29 pm
Forum: ImetelChat
Topic: Why Incyte's Shares Are Tumbling (Motley Fool, 11-02-2016)
Replies: 0
Views: 1655

Why Incyte's Shares Are Tumbling (Motley Fool, 11-02-2016)

Jakafi's solid tumor program goes belly up. by George Budwell What: Shares of Incyte Corporation (NASDAQ:INCY) fell by more than 21% in early morning trading today after the company announced that it is discontinuing the clinical development of Jakafi (ruxolitinib) in solid tumors due to insufficien...
by Fishermangents
Sat Feb 13, 2016 10:10 am
Forum: ImetelChat
Topic: On another note...
Replies: 8
Views: 4640

Re: On another note...

Wow, you are right, Bio. I missed that second press release. Doesn't look good for pacritinib....

Link: http://www.prnewswire.com/news-releases ... 17839.html

(btw: who is Kemosabe?)
by Fishermangents
Fri Feb 12, 2016 8:24 pm
Forum: ImetelChat
Topic: On another note...
Replies: 8
Views: 4640

Re: On another note...

Bio, the Citi press release says it's a partial hold. SEATTLE, Feb. 8, 2016 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA:CTIC) today announced that the Company received written communication from the U.S. Food and Drug Administration (FDA) on February 4, 2016, that the FDA has...
by Fishermangents
Fri Feb 12, 2016 10:51 am
Forum: ImetelChat
Topic: The JAK inhibitor competition, and why Imetelstat out-classes them all
Replies: 0
Views: 1439

The JAK inhibitor competition, and why Imetelstat out-classes them all

repost from sdrawkcabeman (YMB) Everyone's familiar w/Rux's profile which, broadly, is very modest efficacy w/myelosuppression, abnormal LFTs, and up to 89% discontinuation w/in 3 yrs. SNY's Fedratinib was scrapped b/c pts developed Wernicke's encephalopathy. The whole program was written off, this ...
by Fishermangents
Thu Feb 11, 2016 5:07 pm
Forum: ImetelChat
Topic: 1951 study
Replies: 3
Views: 2103

Re: 1951 study

Hi Bio, I will get into it later today, as I am a bit busy right now. Btw: changes on the CT site are not just administrative matters. Changing texts have a good wellthough off reasoning behind. Let's see if we can get a grasp of the wider meaning of these changes.
by Fishermangents
Wed Feb 10, 2016 11:13 pm
Forum: ImetelChat
Topic: On another note...
Replies: 8
Views: 4640

Re: On another note...

This is about pacritnib?
by Fishermangents
Wed Feb 10, 2016 6:56 pm
Forum: ImetelChat
Topic: 1951 study
Replies: 3
Views: 2103

Re: 1951 study

Bio, you raise a very interesting point. I will take a closer at this later, as I am a bit in a hurry. For now I see three significant changes: - duration from 3 to 5 years - the definition of the study-end is changed - they skipped the wordings 'unacceptable toxicity' and changed it into 'as long a...
by Fishermangents
Wed Feb 10, 2016 1:07 pm
Forum: ImetelChat
Topic: Novel Efficient Cell-Penetrating Peptide-Mediated Strategy
Replies: 5
Views: 2349

Re: Novel Efficient Cell-Penetrating Peptide-Mediated Strategy

This is the link to the abstract: http://online.liebertpub.com/doi/abs/10 ... .2015.0558

(I couldn't find a link to the PDF you mentioned)
by Fishermangents
Mon Feb 08, 2016 9:14 pm
Forum: ImetelChat
Topic: A New Tool for Predicting Marketing Approval of Oncology Drugs (JNJ/Tufts University)
Replies: 1
Views: 1489

Re: A New Tool for Predicting Marketing Approval of Oncology Drugs (JNJ/Tufts University)

Phil Pecsok from Seeking Alpha said the following about this tool when applied to imetelstat: ====== This is THE algo that JANSSEN considered when it partnered with Geron. Go to page 4. Note scores are 0-1-2 for each of 4 questions. #1. IMET has 40% activity if you look at CR/PR/CI and higher if you...
by Fishermangents
Mon Feb 08, 2016 9:03 pm
Forum: ImetelChat
Topic: A New Tool for Predicting Marketing Approval of Oncology Drugs (JNJ/Tufts University)
Replies: 1
Views: 1489

A New Tool for Predicting Marketing Approval of Oncology Drugs (JNJ/Tufts University)

Authors: Tufts Center for the Study of Drug Development and Janssen Research & Development R&D Senior Leadership Brief (excerpt of the summary) Starting in 2012, the Tufts Center for the Study of Drug Development (Tufts CSDD) and Janssen Research & Development (JRD) collaborated on a pilot study to ...
by Fishermangents
Mon Feb 08, 2016 5:40 pm
Forum: ImetelChat
Topic: Pacritinib on Partial Hold
Replies: 1
Views: 1152

Re: Pacritinib on Partial Hold

Yes, it is a competing drug. So maybe good news for Geron. But for patients it is bad news, because it performed better than Jakafi.... With the requested changes to the protocol the FDA wants to get a better insight in the mortality cases, partly by not allowing patients crossing over to the other ...
by Fishermangents
Mon Feb 08, 2016 5:12 pm
Forum: ImetelChat
Topic: Pacritinib on Partial Hold
Replies: 1
Views: 1152

Pacritinib on Partial Hold

SEATTLE, Feb. 8, 2016 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA:CTIC) today announced that the Company received written communication from the U.S. Food and Drug Administration (FDA) on February 4, 2016, that the FDA has placed a partial clinical hold on the clinical studie...
by Fishermangents
Mon Feb 08, 2016 1:40 am
Forum: ImetelChat
Topic: Novel Efficient Cell-Penetrating Peptide-Mediated Strategy
Replies: 5
Views: 2349

Re: Novel Efficient Cell-Penetrating Peptide-Mediated Strategy

I took a quick look and I think these are the kind of methods which indeed can improve imetelstat as a platform drug. It is rather technical, so I can not understand it all. Although clinical trials have just started, at Geron and JnJ they probably are already anticipating for imetelstat 2.0. This a...