RRx-001 Prelim. Phase 2 Data - Resensitizing Tumors to chemo

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DK37
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RRx-001 Prelim. Phase 2 Data - Resensitizing Tumors to chemo

Postby DK37 » Wed Mar 18, 2015 8:45 am

I wanted to alert the board that the first preliminary phase 2 clinical trial results for RRx-001 dosed for CRC (randomized against the current stand of care regorafenib) were released this week at this link: http://tatcongress.org/wp-content/uploa ... Carter.pdf

I have been tracking RRx-001 pretty closely for a while. I have been attracted by its minimal side effect profile and signs that it can resensisitze tumors to chemo which had previous the patient had failed (e.g. irinotecan). Conceptually this in theory many allow a treatment pattern where you could alternate between chemo and take shorts bursts of RRx-001 during rest periods to bring back chemo efficacy to convert stage IV CRC into a chronic condition - although that paradigm still has to be clearly proven in clinical trials.

A case study has been published of 2 CRC patients from the Phase 1 trial resensitized to previous chemo: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3934615/
As well as a discussion on this strategy: http://www.sciencedirect.com/science/ar ... 3314000916

To my eyes, the preliminary Phase 2 data seems to be replicating what they saw in the Phase 1 trial (resensitizing multiple CRC patients to previously failed chemo), although the patient numbers are still too small to say conclusively.

Here is the link to the in-progress Phase 2 clinical trial: https://clinicaltrials.gov/ct2/show/NCT02096354

All the best,
-DK
6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
7/12 FOLFOX/FOLFIRI
2/13 NED!
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
3/15 Cetuximab
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)
MSS-CRC Clinical Trial Finder: http://trialfinder.fightcrc.org/
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lpas
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Re: RRx-001 Prelim. Phase 2 Data - Resensitizing Tumors to c

Postby lpas » Wed Mar 18, 2015 10:55 am

Thanks so much for posting, DK. Sounds really promising. I know very little about how the process of clinical trial ---> eventual FDA approval works. Assuming things continue to look positive, do you have any guess as to how long it might be before the drug would be available to all?
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jillbugs4110
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Re: RRx-001 Prelim. Phase 2 Data - Resensitizing Tumors to c

Postby jillbugs4110 » Wed Mar 18, 2015 10:58 am

Are they doing this trial in San diego?
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DK37
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Location: San Diego

Re: RRx-001 Prelim. Phase 2 Data - Resensitizing Tumors to c

Postby DK37 » Wed Mar 18, 2015 1:57 pm

lpas wrote: Assuming things continue to look positive, do you have any guess as to how long it might be before the drug would be available to all?


Hi lpas - there are so many variables that affect how fast or slow the clinical trial/approval process goes, that I can't hazard a guess. It is my impression however that the fact they are already randomizing against SoC in their first Phase 2 trial indicates that they are attempting faster than average timelines.

jillbugs4110 wrote:Are they doing this trial in San diego?


Hi jillbugs4110 - YES, they are doing the trial in San Diego! Specifically at the UCSD-Moores Cancer Center. Dr. Tony Reid is the Principle Investigator for the trial.

-DK
6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
7/12 FOLFOX/FOLFIRI
2/13 NED!
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
3/15 Cetuximab
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)
MSS-CRC Clinical Trial Finder: http://trialfinder.fightcrc.org/
2016 Colondar 2.0 Model
DK37 Science Posts List


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