Drug Doubles Survival Time - Saltikva

I do not know the answer to this question. Again, you can contact Salspera for more information.

The NCT link also has direct contact info for the trial coordinators:
Contact: Gerald Batist, MD (514) 340-8222 gerald.batist@mcgill.ca
Contact: Petr Kavan, MD PhD (514) 340-8222 petr.kavan@mcgill.ca

They're not usually flexible with changes like that when good scientific control is needed, but this one already has two experimental arms (one with Folfirinox, and one with Gem/Abrax) then adding their drug to each.

So, you couldn't likely take ingredients out of the Folfirinox, add ingredients like cisplatin to the Gem/Abrax, or switch regimens midstream w/o messing up their data. They might also have restrictions regarding how long you've already been on one of the regimens. On the other hand, if you've been on one or the other for a while without much response, they might be interested in the "semi-anecdotal" case if adding their drug to your treatment induces more response. (The late add of their drug would not support their head-to-head test of the two arms, but a successful late add could signal a synergy/catalyst that their drug has with one of the SoC chemos.)

I read the same article and had the same questions. I sent this email on Friday to Salspera and waiting for a response. Has anyone seen an answer this question?

“Your article of January 4, 2023 states Saltikva with “standard of care FOLFIRINOX” showed a median survival of 24 months compared with historical, published survival of 11.1 months in patients treated with standard of care FOLFIRINOX alone. Would this also apply to “standard of care” using Gemcitabine /Abraxane?”

Were there trials using either Gemcitabine or Abraxane (or combination of the two)? If so, are there studies/reports on this?

Hi
How long was it to get a response from them ? I emailed them two weeks ago for my mom and I'm still waiting 🙁
I don't know if it's because we're Canadian and then have no access to fast track and compassionate use ?

I've come to the realization that medical professionals don't get in any hurry responding to our questions or concerns even though we're emotionally and physically dying a little every day.

Hi, I believe studies are being done at McGill in Montreal.

The study is actually taking place in Canada. Here's what I found about Saltikva online. Perhaps contact the hospital?
https://www.jgh.ca/care-services/segal-cancer-centre/the-saltikva-study/

I contacted Salspera and got this response from the CEO…
————————-
“Unfortunately, we do not have sufficient data to date with GEM/Abraxane. The data we have with FOLFIRINOX is much further along and highly encouraging.

We can discuss our therapy with your oncologist at the Mayo if this is of interest. Here is a summary that was published recently on our study:

Patient diagnosis: Stage 4, metastasized pancreatic cancer
Treatment: Modified FOLFIRINOX in conjunction with Saltikva, every 2 weeks
Modifications of FOLFIRINOX: Dose reductions, component exemptions, chemo holidays
Number of patients in this arm: 18
Mode of administration for Saltikva: Oral

Overall median survival: 19 months for our group versus 12 months for standard of care at the site
Progression free survival: 15 months in our group versus 5.8 months for standard of care at the site
Safety, Adverse events or serious adverse events: Over 140 events recorded, none of which were found to be attributable to Saltikva; all adverse events were attributed to the chemotherapy by the site oncologists.

Significant and sustained reduction of CA 19.9 and CEA levels
Significant changes in immune modulation with T-cells and NK cells
Significant reduction in tumor sizes shown in CT and PET, analyzed by RECIST 1.1 criteria
Effect was consistent despite significant modifications of the chemotherapy or multiple chemo-holidays”

Further notes:
FDA Orphan Drug Designation
FDA Fast Track designation

Best regards,

--
Eddie Moradian , PhD
Chief Executive Officer

Salspera, Inc.
Cell: (651) 402 5587

@altc321 , thank you for posting this. It does look very encouraging. I'm going to print the CEO's response and take it to my oncologist's appointment tomorrow. I was going to ask about Saltikva anyway, but this provides a lot more info than I had from the original posts. Thanks again!

Good luck with discussing with your oncologist at Mayo. I contacted my sister's previous oncologist at Mayo (she is being treated at her home location at MSK) and neither Mayo nor MSK is on board with Saltikva. At least the oncologist at Mayo provided a thoughtful response where her oncologist at MSK couldn't be bothered with me.