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How can we help push for fast track trials of drugs?
Novelos Therapeutics has reported encouraging results from a Phase II trial of NOV-002 in combination with carboplatin in platinum-resistant ovarian cancer patients.
In this open-label, single-arm Phase II trial, women with platinum-resistant ovarian cancer were treated with up to six cycles of NOV-002 and carboplatin. Efficacy endpoints included progression-free survival (PFS) and tumor response rate. Of 15 evaluable patients, 11 had previously failed three lines of chemotherapy, including platinum-based therapy. Tumors were assessed bi-monthly after at least eight weeks of treatment.
Median PFS was 15.4 weeks and mean PFS was 19.4 weeks. These values compare favorably to published data showing a median PFS of eight weeks in this late-stage, platinum-resistant patient population. Furthermore, five out of 15 women treated with NOV-002 and carboplatin had stable disease for five months (20 weeks) or longer.
In terms of best overall tumor response, one patient achieved a partial response, eight stable disease and six progressive disease. Thus, 60% (nine out of 15) women demonstrated clinical benefit and slowing of disease progression with NOV-002 and carboplatin. Hematologic toxicity was mild, suggesting possible mitigating effect of NOV-002. NOV-002 itself was also well-tolerated, further extending the excellent safety profile that NOV-002 has demonstrated in previous studies.
Harry Palmin, president and CEO of Novelos, said: "We are very pleased that NOV-002 continues to demonstrate activity in multiple tumor types, and we look forward to discussing with the FDA a design for a larger multi-center Phase II trial in ovarian cancer."
My question is, how can those affected with OVCA push these trials through faster and make them available to more women?
In this open-label, single-arm Phase II trial, women with platinum-resistant ovarian cancer were treated with up to six cycles of NOV-002 and carboplatin. Efficacy endpoints included progression-free survival (PFS) and tumor response rate. Of 15 evaluable patients, 11 had previously failed three lines of chemotherapy, including platinum-based therapy. Tumors were assessed bi-monthly after at least eight weeks of treatment.
Median PFS was 15.4 weeks and mean PFS was 19.4 weeks. These values compare favorably to published data showing a median PFS of eight weeks in this late-stage, platinum-resistant patient population. Furthermore, five out of 15 women treated with NOV-002 and carboplatin had stable disease for five months (20 weeks) or longer.
In terms of best overall tumor response, one patient achieved a partial response, eight stable disease and six progressive disease. Thus, 60% (nine out of 15) women demonstrated clinical benefit and slowing of disease progression with NOV-002 and carboplatin. Hematologic toxicity was mild, suggesting possible mitigating effect of NOV-002. NOV-002 itself was also well-tolerated, further extending the excellent safety profile that NOV-002 has demonstrated in previous studies.
Harry Palmin, president and CEO of Novelos, said: "We are very pleased that NOV-002 continues to demonstrate activity in multiple tumor types, and we look forward to discussing with the FDA a design for a larger multi-center Phase II trial in ovarian cancer."
My question is, how can those affected with OVCA push these trials through faster and make them available to more women?
Well, it all boils down to the FDA...one of the mose inefficient agencies around when it comes to this. There is 'fast track' status, but it's anything from 'fast track' normally still taking years to complete trials. The most recent one in memory that really got pushed through somewhat fast was 'Taxol' because, at the time, it was something that was NEEDED in the chemotherapy market (and it could be used by several types of cancers). But you really have to look at the market out there, especially for ovarian cancer, there is nothing that dramatic. Yes there are tweaks here and there, and while some chemo's look extroridnary, especially in the clinical/trial setting, they often fail to live up to expectations (at least to the lab companies) during stage II or even III trials (where the companies want profits above cures...so if a small group can use the chemo to cure their cancer, it will rarely go to market if it is not profitable....they want large scale profits).
This is not to say that it's all a waste, ovarian cancer, like other cancers and different peoples versions, can be affected by these chemo's...the essential 'new' chemo that the cancer is yet not immune to. In today's world, the chemotherapy used, past the initial cycle, is often viewed just to keep the cancer at bay at the best (they do not view it as curative after the initial cycle is completed...yet that is possible!).
The real success will come after the genetics of ovarian cancer (which thankfully was one of three cancers selected to be explored first) are revealed and given to the world to create TRUE cures (if our science can do it at that point).
For platinum resistant cancers, like this one is targeting, there are already existing trials and techniques...such as using a platinum based chemo again. Very true, that using weekly carbo has shown responses in those resistant to it during the monthly infusions. Then there is phenoxodiol which restores chemosensitivity in platinum resistant patients (essentially a mainstream, and thus profitable, version of the soy isoflavone genestein)
Too bad the FDA (and U.S. corporate labs) won't allow Lentinan in the U.S. like they do as first line chemo in Japan...
This is not to say that it's all a waste, ovarian cancer, like other cancers and different peoples versions, can be affected by these chemo's...the essential 'new' chemo that the cancer is yet not immune to. In today's world, the chemotherapy used, past the initial cycle, is often viewed just to keep the cancer at bay at the best (they do not view it as curative after the initial cycle is completed...yet that is possible!).
The real success will come after the genetics of ovarian cancer (which thankfully was one of three cancers selected to be explored first) are revealed and given to the world to create TRUE cures (if our science can do it at that point).
For platinum resistant cancers, like this one is targeting, there are already existing trials and techniques...such as using a platinum based chemo again. Very true, that using weekly carbo has shown responses in those resistant to it during the monthly infusions. Then there is phenoxodiol which restores chemosensitivity in platinum resistant patients (essentially a mainstream, and thus profitable, version of the soy isoflavone genestein)
Too bad the FDA (and U.S. corporate labs) won't allow Lentinan in the U.S. like they do as first line chemo in Japan...
More women can enroll in trials! It amazes me that so few do and the trials that are going on can't get far without women enrolling. I read somewhere that something like 80% of children with cancer enroll and only about 20% adults enroll.
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