Drug Doubles Survival Time - Saltikva

Posted by layla97 @layla97, Nov 23, 2023

Anyone know how to obtain the drug Saltikva which earned fast-track FDA approval in Jan 2022. Studies have shown the Salmonella IL2 drug Saltikva doubled survival time for Stage IV pancreatic cancer which is why it was fast-tracked for approval by the FDA. It is administered orally in combination with Folfirinox every 2 weeks. You would think a cancer hospital specialty like The Mayo Clinic, or Sloane-Kettering in NYC would offer this. My sister was diagnosed in July and has had 5 infusions of Folfirinox. I am an NP and discovered this online while looking for additional drugs for this purpose.

Interested in more discussions like this? Go to the Pancreatic Cancer Support Group.

@layla97

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.

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@layla97 , can you be more specific about your sister's MDs and their reluctance/refusal to consider Saltikva? Please don't reveal anything personal about your sister's situation, but I'd be curious to know what their concerns were. As I posted above, I'm doing my regular consult with my oncologist this afternoon, and I was going to ask him about Saltikva. I don't think I'm "there" yet, as my CA 19-9 is in normal range and my CT scans show that my main tumor has shrunk, so we're still getting good results with my Folfiri regimen. But having that info could help me frame better questions and get more info. Thanks in advance for anything you can provide.

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@altc321

I contacted Salspera and got this response from the CEO…
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“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

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The area code of the phone number that was provided is that of the St. Paul, MN area…

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@mikewdby

The area code of the phone number that was provided is that of the St. Paul, MN area…

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I'm not the person who posted that. However, I did note that the phone number was listed as a cell phone. It wouldn't surprise me if the person holding that number got it in Minnesota, then moved to one or more locations but kept the same cell number.

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@ncteacher

@layla97 , can you be more specific about your sister's MDs and their reluctance/refusal to consider Saltikva? Please don't reveal anything personal about your sister's situation, but I'd be curious to know what their concerns were. As I posted above, I'm doing my regular consult with my oncologist this afternoon, and I was going to ask him about Saltikva. I don't think I'm "there" yet, as my CA 19-9 is in normal range and my CT scans show that my main tumor has shrunk, so we're still getting good results with my Folfiri regimen. But having that info could help me frame better questions and get more info. Thanks in advance for anything you can provide.

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She is having good results from Folfirinox so far after 6 infusions. Before her 5th infusion I sat in with her video call to her oncologist at MSK. I mentioned Saltikva and he said he didn't feel comfortable with giving a "live" substance to an immunocompromised patient (not his exact words), and quickly changed to subject. I am not a physician, but a Nurse Practitioner for over 35 years , now retired. I was sure I read this was "attenuated" in the study, but did not want to interrupt my sister's visit. I went back that evening to re-read the word "attenuated" and I was correct. I also wrote back to Salspera to confirm. They told me I was correct --- the Salmonella Il-2 drug is attenuated (meaning weakened to the point of being unable to cause disease). I sent the letter to her MSK Onco and he never replied. I left out the names of the physicians.
Since my cousin is a surgeon at Mayo, he said it certainly was reasonable to contact the oncologist at Mayo (where she went for second opinion). he replied the very next day with this:

Reviewed the abstract for this Saltikva. Some of the mechanism described is a little dubious, plus strange to report only partial data from the phase II and the wording was bit sales pitchy. Also there was no benefit in the arm that used a different chemo-regimen - why would that be??. I am uncertain if this would at all beneficial. If this is something they would let her be a part of without having to pay out of pocket and would not change her current chemotherapy regimen than it would be up to her to make this decision, but the data as it stands currently would not support that this is beneficial.

Ultimately the decision is up to you and your treating oncologist. We would encourage you to ask Dr. ------ for his input if you still need more information. Dr. ---- did reach out to Dr. ------ to ask about it based on your message. I do believe he and Dr. ----- had some of the same questions and concerns.

We know these are difficult decisions and you are only hoping to find something to offer improvement in her quality and quantity of life. We wish you the best in your search.

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From the earlier reply, I didn't infer so much as they didn't get good data from the Gem/Abraxane arm as they just didn't have as much data from it. That could be a way to obscure info or might just be the true status given the number of patients enrolled in the study so far.

I don't expect an institution like McGill would ever deliberately sugar-coat or cherry-pick results. Some of what I read also sounded "sales-pitchey" but I think that was written by Salspera personnel instead of the McGill researchers. Always important to follow the money and consider the source!!!

There are some other interesting, independent papers related to using the salmonella bacteria to treat pancreatic cancer, so it doesn't seem to be outright snake-oil.

FWIW, regarding attenuated bacteria... some of the different papers discussed how to engineer and select the salmonella bacteria for certain traits.

I don't know if a generic chemo patient would be at risk with an attenuated bacteria, but someone obviously more immunocompromised or missing a spleen might be more at risk. I have some metal hardware implanted in my body (a loop recorder and some stainless steel screws), and they disqualified me from one clinical trial I inquired about. That study was also using bacteria as a way to reach the tumor, but they were concerned the bacteria could attach itself to the hardware in my body and become impossible to treat. So, as with most things, "It depends."

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Is Saltikva only used with the Fulf?
My mom was on Fulf for a few months and it did nothing and CA19 skyrocketed. She’s on Gemcitibine now. It’s sort of holding steady but not 100% of the spots. The Drs at msk and mayo say they’ve never heard of saltikva. I guess they only use fda approved meds.

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@cpmcb

Is Saltikva only used with the Fulf?
My mom was on Fulf for a few months and it did nothing and CA19 skyrocketed. She’s on Gemcitibine now. It’s sort of holding steady but not 100% of the spots. The Drs at msk and mayo say they’ve never heard of saltikva. I guess they only use fda approved meds.

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The various websites say they also have a Gem+Abrax+Saltikva arm.

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I have researched the drug and corresponded with the company. It can be made available under a “compassionate use” distribution with Gemzar or 5Fu.

Would really want your oncologist to research. Many are unwilling to do anything not in the “standard of care”

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Is Gemzar same as Gemcitibine?

What would process be? Ask oncologist to contact Salspera directly?

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@cpmcb

Is Gemzar same as Gemcitibine?

What would process be? Ask oncologist to contact Salspera directly?

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Ask oncologist to review the papers on Saltikva. However, I agree with @gamaryanne that many are not willing to stray from the standard of care. Certainly my sister's oncologist at MSK was not (though he couldn't even send me a response directly), and the thoughtful oncologist at Mayo sent a response but is also not on board (sigh).

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