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Phase 3 new chemo drug
About phenoxodiol: another new drug on the horizon
Phenoxodiol is being developed as a chemosensitizing agent in combination with platinum drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for prostate and cervical cancers. It has a unique mechanism of action, binding to cancer cells via a cell membrane oxidase, causing major downstream disturbances in expression of proteins necessary for cancer cell survival and responsible for the development of drug resistance.
In cancer cells, phenoxodiol appears to selectively inhibit the regulator known as S-1-P (sphingosine-1-phosphate) that is overexpressed in cancer cells. In response to phenoxodiol, the S-1-P content in cancer cells is decreased, with a consequent decrease in expression of the pro-survival proteins XIAP and FLIP, rendering those cells more sensitive to chemotherapy. Indeed, in laboratory studies, it has been demonstrated that drug-resistant ovarian cancer cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy drugs.
Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing.
Phenoxodiol is being investigated as a therapy for late-stage, chemoresistant ovarian, prostate and cervical cancers. Phenoxodiol has received Fast Track status from the FDA to facilitate its development as a therapy for recurrent ovarian and prostate cancers.
Phenoxodiol is an investigational drug and, as such, is not commercially available. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by FDA as being safe and effective for the intended use.
Phenoxodiol is being developed as a chemosensitizing agent in combination with platinum drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for prostate and cervical cancers. It has a unique mechanism of action, binding to cancer cells via a cell membrane oxidase, causing major downstream disturbances in expression of proteins necessary for cancer cell survival and responsible for the development of drug resistance.
In cancer cells, phenoxodiol appears to selectively inhibit the regulator known as S-1-P (sphingosine-1-phosphate) that is overexpressed in cancer cells. In response to phenoxodiol, the S-1-P content in cancer cells is decreased, with a consequent decrease in expression of the pro-survival proteins XIAP and FLIP, rendering those cells more sensitive to chemotherapy. Indeed, in laboratory studies, it has been demonstrated that drug-resistant ovarian cancer cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy drugs.
Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing.
Phenoxodiol is being investigated as a therapy for late-stage, chemoresistant ovarian, prostate and cervical cancers. Phenoxodiol has received Fast Track status from the FDA to facilitate its development as a therapy for recurrent ovarian and prostate cancers.
Phenoxodiol is an investigational drug and, as such, is not commercially available. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by FDA as being safe and effective for the intended use.
yes that's right, they will always give you carbo with active drug pxdl or with placebo pxdl.
www.OVATUREtrial.com is advertising a Phase 111 clinical trial for phenoxodiol and or carboplatin.
Yep, this was my favorite chemo drug I posted about a few times. It's simply Genestein (from fermented soy) they tweaked a little bit (does the same thing, just a little bit more targeted...).
Fast track is anything but with the FDA...although it sounds good, it's only roughly about 5 years (if we're lucky) sooner than a regular FDA clinical trial (you are still looking at a 10 year clinical study trial length at least). Phase III requires them to meet their quota goals of testers and then there is the evaluation period after that and then the fda approval procedures, etc, etc.
They are going to make it available via tablets/pills instead of intravenous (IV) like they tested very early on in Phase I testing. Although IV worked just as well, they are going the tablet route. So, if you are on TPN or whatever because you can't eat, this may not be a 'drug' for you (when it becomes available).
I wish they would rush it through like they did when Taxol was in testing, that went through quickly. Just remember if you are platinum resistant there are ways to still take platinum drugs (such as weekly carbo instead of monthly will have an effect on platinum resistant ovca).
Fast track is anything but with the FDA...although it sounds good, it's only roughly about 5 years (if we're lucky) sooner than a regular FDA clinical trial (you are still looking at a 10 year clinical study trial length at least). Phase III requires them to meet their quota goals of testers and then there is the evaluation period after that and then the fda approval procedures, etc, etc.
They are going to make it available via tablets/pills instead of intravenous (IV) like they tested very early on in Phase I testing. Although IV worked just as well, they are going the tablet route. So, if you are on TPN or whatever because you can't eat, this may not be a 'drug' for you (when it becomes available).
I wish they would rush it through like they did when Taxol was in testing, that went through quickly. Just remember if you are platinum resistant there are ways to still take platinum drugs (such as weekly carbo instead of monthly will have an effect on platinum resistant ovca).
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