This study is interesting. Rats bearing C6 rat gliomas and treated with oxaloacetate in the drinking water had tumors about half as large as the controls at day 14.
In a second experiment, nude mice treated with oxaloacetate + human glutamate-oxaloacetate transaminase (hGOT) had tumors ~20% smaller than tumors in control mice. Combinine oxaloacetate + hGOT with temozolomide led to tumors about half the size of tumors treated with TMZ alone.
However, there was no direct comparison of oxaloacetate alone versus oxaloacetate + GOT. This is important since the Cronaxal product is a combination of oxaloacetate + vitamin C (without GOT).
The cronaxal website provides a copy of the letter from the FDA granting orphan drug status to oxaloacetate for glioma. I couldn't find information about this elsewhere online after a brief search.
http://cronaxal.com/4.html
The data is preliminary, but so is the data for most of the things we discuss here. Looks to me like there is some merit in this.
Current recommended dose of CRONaxal on the website is 500 mg three times daily (or 15 capsules total per day). Retail price for this dose would be around $550 - $650 per month, but it might be possible for GBM patients to get it at wholesale prices. Ask the company.
In the study mentioned above -http://www.ncbi.nlm.nih.gov/pubmed/22392507 ) - where oxaloacetate in the drinking water slowed growth of C6 rat gliomas, the concentration of oxaloacetate consumed was 0.2 moles per liter. This translates to 26.4 grams per liter. Assuming a mouse weight of 20 grams and a water consumption of 3 mL per day, the mice would have consumed approximately 80 mg of oxaloacetate per day (26.4 x 0.003 x 1000), or 4000 mg/kg body weight (80 / 0.02 kg). Translating this to a human dose using allometric scaling formula, this would be the equivalent of a 65 kg human consuming 20 grams of oxaloacetate per day. I was unable to find any safety information on oxaloacetate in humans above 200 mg per day after only a brief search.
My point is that very high doses of oxaloacetate (with uncertain safety at those doses) may be required to replicate the effects seen in the rat study.
This trial is testing up to 2 grams per day for Alzheimers, but the primary completion date of the trial is Oct 2017, so likely no information for a good long while.
There was a post about this in the last few days on Musella's BrainTumor-Treatments yahoo group (join this group and other groups at virtualtrials.com). The message there was as follows:
"I heard back from the company that makes it..
On August 5, Terra Biological LLC voluntarily removed the CRONaxal Medical Food product from the market. This is not a recall, but a voluntary product discontinuation. This was done in direct response to a letter from the US FDA expressing concern that CRONaxal is not a medical food.
The FDA letter, in part, states the following: "FDA is not aware of any distinctive nutritional requirements for individuals with Glial Tumors, Glioblastoma Multiforme (GBM) and Astrocytoma. Therefore, your CRONaxal (oxaloacetate) product does not meet the definition of a medical food in the Orphan Drug Act". In a related footnote, the FDA letter also states: "We note that, although oxaloacetate may confer some benefit to certain individuals with glial tumors, the provision of oxaloacetate is not based on any nutritional need. Further, the efficacy of dietary therapies in the management of glial tumors is unknown given the limited human clinical data."
As such, the CRONaxal product is discontinued and there is no replacement product on the market for the dietary management of persons being treated for glial tumors.
With this decision, however, we are redoubling our efforts to bring specific oxaloacetate preparations through the drug approval process. To date, we have had a Pre-Investigational New Drug meeting with the FDA, and we are currently working on certain improvements so that we may initiate clinical trials. Our start date for the trials is tentatively set for early next year.
Persons interested in taking oxaloacetate dietary supplements for energy or mood support may consider oxaloacetate supplements that remain available in the marketplace. Please note that dietary supplements are not intended for use in the diagnosis, cure, mitigation, treatment or prevention of any disease.
Al, if you have any further questions, please do not hesitate to contact me. You can call me also at 858-947-5722. Please let your readership know what is happening here...."
The BenaGene website is still up however. This is product is made by Terra Biological, the same company behind CRONaxal. It is likely a similar, if not identical product.
how long have you been taking it? Except cognitive clarity, did you find some degree of controlling the brain disease, which will become our main goal to use it.
I believe that I have been taking 4-5 lozenges a day since 3/2016. I do so many things that I am not sure what controls my brain disease. Sorry I'm not more scientific and can't help more. I also find amazing energy and clarity from www.ldninfo.org. The compounding company that I got it from in NYC went out of business so I was without it for a few days. I could not get off the couch until I had it in my system again for about 36 hours. That made me realize the quality of life that I have obtained from ldn is priceless. My next MRI is in Sept hopefully we will have no progression. If we are going by how I feel it's working. Good Luck to you.
The study this is based on is here:
ReplyDeletehttp://www.ncbi.nlm.nih.gov/pubmed/22392507
I hadn't seen this one before, so thanks for posting. I'll be reading it tomorrow.
Great - looking forward to your thoughts on it.
DeleteThis study is interesting. Rats bearing C6 rat gliomas and treated with oxaloacetate in the drinking water had tumors about half as large as the controls at day 14.
ReplyDeleteIn a second experiment, nude mice treated with oxaloacetate + human glutamate-oxaloacetate transaminase (hGOT) had tumors ~20% smaller than tumors in control mice. Combinine oxaloacetate + hGOT with temozolomide led to tumors about half the size of tumors treated with TMZ alone.
However, there was no direct comparison of oxaloacetate alone versus oxaloacetate + GOT. This is important since the Cronaxal product is a combination of oxaloacetate + vitamin C (without GOT).
The cronaxal website provides a copy of the letter from the FDA granting orphan drug status to oxaloacetate for glioma. I couldn't find information about this elsewhere online after a brief search.
http://cronaxal.com/4.html
The data is preliminary, but so is the data for most of the things we discuss here. Looks to me like there is some merit in this.
I read the site a bit more closely; 60 pills a day is the recommended dose for GBM patients. That seems bordering on ridiculous.
DeleteIf that's the case, I wonder if it could just be purchased as a bulk powder and dissolved in a liquid, like DCA.
DeleteNot to mention extremely expensive - 1500 dollars per month for these dosages
DeleteI couldn't find any recommended dose on the CRONaxal website at
Deletehttp://cronaxal.com/index.html
Current recommended dose of CRONaxal on the website is 500 mg three times daily (or 15 capsules total per day). Retail price for this dose would be around $550 - $650 per month, but it might be possible for GBM patients to get it at wholesale prices. Ask the company.
DeleteIn the study mentioned above -http://www.ncbi.nlm.nih.gov/pubmed/22392507 ) - where oxaloacetate in the drinking water slowed growth of C6 rat gliomas, the concentration of oxaloacetate consumed was 0.2 moles per liter. This translates to 26.4 grams per liter. Assuming a mouse weight of 20 grams and a water consumption of 3 mL per day, the mice would have consumed approximately 80 mg of oxaloacetate per day (26.4 x 0.003 x 1000), or 4000 mg/kg body weight (80 / 0.02 kg). Translating this to a human dose using allometric scaling formula, this would be the equivalent of a 65 kg human consuming 20 grams of oxaloacetate per day. I was unable to find any safety information on oxaloacetate in humans above 200 mg per day after only a brief search.
ReplyDeletehttp://www.sciencedirect.com/science/article/pii/S2214647416300095
My point is that very high doses of oxaloacetate (with uncertain safety at those doses) may be required to replicate the effects seen in the rat study.
This trial is testing up to 2 grams per day for Alzheimers, but the primary completion date of the trial is Oct 2017, so likely no information for a good long while.
Deletehttps://www.clinicaltrials.gov/ct/show/NCT02593318
just went to http://cronaxal.com/index.html, which shows CRONaxal is no longer available.
ReplyDeleteAny opinion?
There was a post about this in the last few days on Musella's BrainTumor-Treatments yahoo group (join this group and other groups at virtualtrials.com). The message there was as follows:
Delete"I heard back from the company that makes it..
On August 5, Terra Biological LLC voluntarily removed the CRONaxal Medical Food product from the market. This is not a recall, but a voluntary product discontinuation. This was done in direct response to a letter from the US FDA expressing concern that CRONaxal is not a medical food.
The FDA letter, in part, states the following: "FDA is not aware of any distinctive nutritional requirements for individuals with Glial Tumors, Glioblastoma Multiforme (GBM) and Astrocytoma. Therefore, your CRONaxal (oxaloacetate) product does not meet the definition of a medical food in the Orphan Drug Act". In a related footnote, the FDA letter also states: "We note that, although oxaloacetate may confer some benefit to certain individuals with glial tumors, the provision of oxaloacetate is not based on any nutritional need. Further, the efficacy of dietary therapies in the management of glial tumors is unknown given the limited human clinical data."
As such, the CRONaxal product is discontinued and there is no replacement product on the market for the dietary management of persons being treated for glial tumors.
With this decision, however, we are redoubling our efforts to bring specific oxaloacetate preparations through the drug approval process. To date, we have had a Pre-Investigational New Drug meeting with the FDA, and we are currently working on certain improvements so that we may initiate clinical trials. Our start date for the trials is tentatively set for early next year.
Persons interested in taking oxaloacetate dietary supplements for energy or mood support may consider oxaloacetate supplements that remain available in the marketplace. Please note that dietary supplements are not intended for use in the diagnosis, cure, mitigation, treatment or prevention of any disease.
Al, if you have any further questions, please do not hesitate to contact me. You can call me also at 858-947-5722. Please let your readership know what is happening here...."
The BenaGene website is still up however. This is product is made by Terra Biological, the same company behind CRONaxal. It is likely a similar, if not identical product.
Deletehttp://www.benagene.com/
Take Benagene, ingredients are the same.
ReplyDeleteany body had the experience in using it (Oxaloacetate)?
ReplyDeleteAmazing cognitive clarity within 30 min of lozenge for me.
ReplyDeletehow long have you been taking it? Except cognitive clarity, did you find some degree of controlling the brain disease, which will become our main goal to use it.
DeleteThank you Michelle
I believe that I have been taking 4-5 lozenges a day since 3/2016. I do so many things that I am not sure what controls my brain disease. Sorry I'm not more scientific and can't help more. I also find amazing energy and clarity from www.ldninfo.org. The compounding company that I got it from in NYC went out of business so I was without it for a few days. I could not get off the couch until I had it in my system again for about 36 hours. That made me realize the quality of life that I have obtained from ldn is priceless. My next MRI is in Sept hopefully we will have no progression. If we are going by how I feel it's working. Good Luck to you.
ReplyDelete