Search found 23 matches

by j6proulx
Mon Aug 05, 2019 8:18 pm
Forum: ImetelChat
Topic: New Hires Continue
Replies: 2
Views: 2713

Re: New Hires Continue

Director, Drug Substance (API) Manufacturing https://www.linkedin.com/comm/jobs/view/1404133083?alertAction=markasviewed&savedSearchAuthToken=1%26AQGHdOmPKaeLfAAAAWxi5UccuNLQFULgUn2NvVSUv-6qm-28sIeFQJ4uAdpw8rybP8JN7pX7dnQhsHr54oRk_UzmZc1xMPgWEMjNbDj0TOzd6bKdqBOvpzy4avH966QbzbtT_k-QnRQ5Jwpasp4IFVuCUc...
by j6proulx
Wed Jul 31, 2019 9:12 pm
Forum: ImetelChat
Topic: New Hires Continue
Replies: 2
Views: 2713

Re: New Hires Continue

Associate Director / Regulatory Affairs https://www.linkedin.com/comm/jobs/view/1393446010?alertAction=markasviewed&savedSearchAuthToken=1%26AQEmK-3jFSU3cAAAAWxJLWRkQplpqLm3l6WaU6ye-cHMXJvEka5EXObaXbNVlXhO9shnAw647E3oXTrI5Om1suvgWgtKlUOetoa9HiVBFiDqgMhOfTbwQX0LwGJmcxzo8T7Q_roM4YXO9fbuCuUais5-ZGgXVW3...
by j6proulx
Mon Jul 29, 2019 7:04 pm
Forum: ImetelChat
Topic: Janssen Patent Application
Replies: 3
Views: 2216

Janssen Patent Application

Just came across this patent application (http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=9&f=G&l=50&co1=AND&d=PG01&s1=imetelstat&OS=imetelstat&RS=imetelstat) from Janssen dated January 31, 2019 (sorry if this is not new here). The timin...
by j6proulx
Fri Jan 18, 2019 10:02 pm
Forum: ImetelChat
Topic: iMbark - Extension Phase Extended
Replies: 1
Views: 1372

iMbark - Extension Phase Extended

The study status and study description for the iMbark trial on clinicaltrials.gov was updated today to add a year to the extension phase to continue monitoring for overall survival and adverse events:
https://clinicaltrials.gov/ct2/history/ ... 2&C=merged
by j6proulx
Thu Sep 20, 2018 3:36 am
Forum: ImetelChat
Topic: Why Imbark gets approved
Replies: 7
Views: 4906

Re: Why Imbark gets approved

Timely question. Janssen is certainly willing to try: https://www.janssen.com/janssen-submits-new-drug-application-us-fda-seeking-approval-erdafitinib-treatment-metastatic "HORSHAM, Pa., Sept. 18, 2018 -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New D...
by j6proulx
Wed Sep 19, 2018 6:26 pm
Forum: ImetelChat
Topic: Why Imbark gets approved
Replies: 7
Views: 4906

Re: Why Imbark gets approved

Regarding the effectiveness of various doses of imetelstat, I have been impressed with the responses of the MDS patients, for example, as shown on Slide 11 of the EAH presentation from June ( https://www.geron.com/file.cfm/53/docs/Imetelstat-IMergePart1-EHA-2018.pdf ). The dot represents a dose of 7...
by j6proulx
Mon Sep 17, 2018 4:34 pm
Forum: ImetelChat
Topic: The OTHER Janssen Agreement
Replies: 2
Views: 3901

The OTHER Janssen Agreement

As is common knowledge, Janssen and Geron have a second license agreement signed following the imetelstat collaboration agreement. Janssen licensed additional patents and rights from Geron to develop new drugs outside the field of telomerase inhibition. The agreement provides for annual license fees...
by j6proulx
Fri Sep 14, 2018 4:46 pm
Forum: ImetelChat
Topic: Ongoing Trial Updates
Replies: 6
Views: 3054

Re: Ongoing Trial Updates

Just a minor curiosity item ... the study status for the withdrawn GRN1005 study in brain metastases from breast or lung cancer continues to be updated quite regularly:

https://clinicaltrials.gov/ct2/history/NCT01679743

I'd love to know what that's all about.
by j6proulx
Tue Aug 28, 2018 11:03 pm
Forum: ImetelChat
Topic: Upcoming Catalysts
Replies: 5
Views: 8519

Upcoming Catalysts

It's been a long quiet period up until the past few days but there are a number of catalysts on the horizon. Here's a quick list of what I anticipate to be the many potentially market-moving events for GERN in the coming weeks and months: 1. 9/13 – JNJ Pharmaceutical Business Conference Call 2. 9/13...
by j6proulx
Thu Aug 23, 2018 8:39 pm
Forum: ImetelChat
Topic: Ongoing Trial Updates
Replies: 6
Views: 3054

Re: Ongoing Trial Updates

I had not considered the "right to try" or compassionate use as a possible explanation. That would be very compelling.
by j6proulx
Thu Aug 23, 2018 4:23 pm
Forum: ImetelChat
Topic: Ongoing Trial Updates
Replies: 6
Views: 3054

Re: Ongoing Trial Updates

The study status for GRN1005 was updated again yesterday.
https://clinicaltrials.gov/ct2/history/ ... 5&C=merged
Very curious.

j6p
by j6proulx
Tue Aug 21, 2018 12:19 am
Forum: ImetelChat
Topic: Ongoing Trial Updates
Replies: 6
Views: 3054

Ongoing Trial Updates

One of the aspects of the current status of imetelstat's evolution that is so curious to me is the ongoing updates to all of the clinical trials, not just IMbark and IMerge. There was an update on August 7 on an old trial evaluating imetelstat in younger patients with relapsed or refractory solid tu...
by j6proulx
Fri Aug 17, 2018 6:15 pm
Forum: ImetelChat
Topic: New Patent / IMET 2.0 ?
Replies: 3
Views: 2232

Re: New Patent / IMET 2.0 ?

There was a second patent issued to Geron on July 31 that I overlooked: m Synthesis of protected 3'-amino nucleoside monomers Abstract Orthogonally protected 3'-amino nucleoside monomers and efficient methods for their synthesis are described. The methods employ selective protection of the 3'-amino ...
by j6proulx
Mon Aug 13, 2018 7:44 pm
Forum: ImetelChat
Topic: New Patent / IMET 2.0 ?
Replies: 3
Views: 2232

New Patent / IMET 2.0 ?

A new patent was issued to Geron on July 31, 2018, relating to compounds useful in inhibiting telomere elongation. See: https://tinyurl.com/y976ctrh (link to USPTO patent). I've yet to review and would welcome comments from others who do.

Best regards,
j6p
by j6proulx
Thu Aug 02, 2018 5:15 am
Forum: ImetelChat
Topic: An excellent article by Hoosier Investor on SA
Replies: 7
Views: 3907

Re: An excellent article by Hoosier Investor on SA

A postscript:

GERN is confident the continuation decision will be coming in Q3. One way to have such confidence is to know the FDA has a PDUFA decision date prior to September 30, if JNJ has submitted its NDA application. Just thinking out loud.

j6p
by j6proulx
Wed Aug 01, 2018 8:29 pm
Forum: ImetelChat
Topic: An excellent article by Hoosier Investor on SA
Replies: 7
Views: 3907

Re: An excellent article by Hoosier Investor on SA

My current theory is that JNJ has applied for accelerated approval for MF based on the primary analysis of IMbark and needs the FDA's decision in order to present GERN with a clinical development plan. In other words, JNJ needs to know if a future registration study is still needed for MF or if IMba...
by j6proulx
Wed Jul 25, 2018 6:54 am
Forum: ImetelChat
Topic: Look for the Continuation Decision next week
Replies: 3
Views: 2931

Re: Look for the Continuation Decision next week

I share your opinion that I expect the continuation decision in the near future. This week will be three full months since the primary analysis began for IMbark. We know that Janssen has to complete the primary analysis and also submit a clinical development plan for Geron's consideration of whether...
by j6proulx
Fri Jul 20, 2018 3:58 pm
Forum: ImetelChat
Topic: Mayo Study Complete
Replies: 0
Views: 2304

Mayo Study Complete

Janssen updated the ClinicalTrials.Gov site for the Mayo study today to change the status from "Active, Not Recruiting" to "Complete" with a completion date of May 24, 2018. m Interestingly, results were posted today to a separate study of imetelstat conducted by the Pediatric Br...
by j6proulx
Wed Jul 18, 2018 7:34 pm
Forum: ImetelChat
Topic: FDA Thoughts on Accelerated Approval
Replies: 6
Views: 5131

FDA Thoughts on Accelerated Approval

I found these articles to be of interest with respect to the FDA's approach to supporting accelerated approvals of single-arm studies that do not include a placebo/control arm. The articles are authored/co-authored by Gideon Blumenthan, MD, who is the Deputy Director (acting) of the Office of Hemato...
by j6proulx
Mon Jul 16, 2018 9:30 pm
Forum: ImetelChat
Topic: New Patent Includes Imetelstat
Replies: 2
Views: 3052

New Patent Includes Imetelstat

Novartis was issued a patent last week for a new molecular entity that inhibits tankyrase, which can have a cascading effect on temolere access to telomerase. The patent is for Novartis's NME but includes its use in combination with other drugs, including imetelstat: http://patft.uspto.gov/netacgi/n...