Seems to be directly competitive to Telcyta, yes. Going after the same patient populations. Very different MOAs, wonder if they'd be synergystic. Monotherapy wasn't expected to do much, it's the challenge afterward that looks interesting. You may recall this from a PR last year:
>>Yale University study shows monotherapy response in advanced ovarian cancer
The second set of clinical trial data discussed at the conference concerned the intravenous dosage formulation of phenoxodiol. This was a Phase 2 study of monotherapy phenoxodiol in 40 patients with late-stage, unresponsive, recurrent ovarian cancer.
On average, these patients had undergone 5 different chemotherapy regimens, and all patients failed to respond to salvage therapy. The patients were treated with phenoxodiol in an attempt to determine whether phenoxodiol had any anti-tumor effect in such late-stage tumors, and if so, to identify the appropriate dosage to be used in a follow-up study where it would be used in combination with standard chemotoxic drugs.
Intravenous phenoxodiol was administered on 2 consecutive days per week; patients were randomized to 4 dose levels – 1, 3, 10 and 20 mg/kg. Treatment continued until patients showed disease progression. Response to therapy was assessed on the basis of a fall in blood levels of the ovarian tumor marker (CA125), shrinkage of the tumor mass, or improved clinical status.
Ten (25%) of the 40 patients had responded when assessed after 6 weeks of treatment, although tumor mass was not assessed at this time. In 6 of these patients, CA125 levels had fallen by an average 54%; in the other 4 patients, rapidly rising CA125 levels before the trial commenced had stopped rising (stabilization) at 6 weeks. At 3 months, 4 of these 10 patients showed stabilized CA125 levels. Almost all of these responders were in the 2 lowest dosage groups, confirming laboratory studies that showed a greater anti-tumor effect for ovarian cancer at lower dosages for phenoxodiol.
Phenoxodiol restores chemo-sensitivity in patients with advanced ovarian cancer
Relevant data, however, in terms of the company strategy of developing phenoxodiol as a chemo-sensitizing agent for late-stage cancers, came from the follow-up management of these patients. Following completion of the phenoxodiol therapy because of disease progression, a number of the patients were re-challenged with standard chemotoxic drugs in order to test what effect phenoxodiol therapy had on their sensitivity to standard anti-cancer drugs. Because all patients had recurrent disease despite being heavily treated with chemotherapy, a clinical response to further chemotherapy was considered unlikely.
In 10 patients who received paclitaxel, 8 of the 10 responded with an immediate and marked decline (average 64%) in their CA125 levels; the other 2 women failed to respond and showed progressive disease. Five of the 10 women treated with paclitaxel were previously considered either resistant or refractory to paclitaxel (that is, their disease previously either had recurred within 6 months of paclitaxel therapy, or continued to worsen despite paclitaxel therapy). However, after treatment with phenoxodiol and subsequent treatment with paclitaxel, 4 of these 5 patients showed a marked response in their CA125 levels, and 3 remain alive after an average of 292 days. These patients have yet to be assessed radiographically to determine the degree of objective tumor response.
Dr. Thomas Rutherford of the Yale University School of Medicine, and Principal Investigator in the study, said, “we are excited that phenoxodiol has been able to provide an effect in women whose disease has been so heavily pre-treated and for whom we have run out of options”.
“But we have always believed that the best way to use the drug was as a chemo-sensitizer, restoring the cancer cell’s susceptibility to standard drugs once they have become resistant to those drugs,” Rutherford added. “That is why this preliminary finding with phenoxodiol and paclitaxel is so exciting. We have seen women positively respond to paclitaxel after being pre-treated with phenoxodiol despite their earlier resistance to paclitaxel.” Dr. Kelly said, “This trial represents the first stage of a two-part program to develop phenoxodiol as a chemo-sensitizer in ovarian cancer patients. The trial has been successful in helping us identify an appropriate, well-tolerated dose of 3 milligrams per kilogram.” <<
Checked out AACR and ASCO programs. Some preclinical, MOA type stuff, nothing share price moving. MEI said it would entertain outlicensing discussions this year, but I think they're going to await more data, and it will be this late year or some time next year that they'd announce a partner. Anyhow, recently took a position, and tempted to add.
Cheers, Tuck |
