NOVOGEN DROPS 57% ON NON-SIGNIFICANT PHASE III CANCER TRIAL
June 28th 2010 01:19
Wednesday June 2, 2010
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECH DOWN: ANTISENSE UP 7%; NOVOGEN DOWN 53%
* NOVOGEN DROPS 57% ON NON-SIGNIFICANT PHASE III CANCER TRIAL
* BIOGUIDE BRIEF: NOVOGEN JOINS THE FAILED PHASE III CLUB
* AUSTRALIAN STEM CELL CENTRE FUNDS RUN OUT JUNE 2011
* EVADO’S ASEAN CLINICAL TRIALS JOINT VENTURE
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NOVOGEN
Novogen fell as much as 57.0 percent to 17 cents in early trading following the release of non-significant results for its 142-patient phase III phenoxodiol ovarian cancer trial.
Novogen said the announcement came through its 72 percent US subsidiary Marshall Edwards which licenced phenoxodiol and dosed the first phase III trial patient in 2006.
The company said the trial of oral phenoxodiol in women with recurrent ovarian cancer “determined that the trial did not show a statistically significant improvement in its primary (progression-free survival) or secondary (overall survival) endpoints”.
Last year, the trial was closed for recruitment with 142 of the planned 340 patients enrolled to conserve cash (BD: Apr 15, 2009).
The multi-centre, randomized, double-blind trial studied daily phenoxodiol in combination with weekly carboplatin, versus weekly carboplatin with placebo in patients with platinum-resistant or platinum-refractory, late-stage epithelial ovarian, fallopian or primary peritoneal cancer following at least second line platinum therapy.
Marshall Edwards’ chief executive officer Dr Daniel Gold said that “owing to the fact that this trial was significantly underpowered due to the small number of patients enrolled, we were disappointed, but not entirely surprised by the final outcome”.
“However, we remain confident that our investigational isoflavone platform, including triphendiol, a potentially more potent, second-generation analogue of phenoxodiol, may be of benefit to women with ovarian cancer, particularly when administered intravenously,” Dr Gold said.
Dr Gold said that previously reported results of a phase II trial demonstrated a 30 percent response rate (six patients of 20), when testing the activity of intravenous phenoxodiol plus weekly cisplatin in a similar platinum-resistant or refractory patient population, compared to less than one percent (one patient of 142 patients) in the phase III study in which phenoxodiol was administered orally.
Dr Gold said his company remained “excited with the progress of another product candidate in our pipeline, NV-128, a novel isoflavone analogue with a mode of action distinct from both phenoxodiol and triphendiol”.
Novogen’s director of research Prof Alan Husband told Biotech Daily that the phase II trial indicated up to 12-weeks progression-free advantage with intravenous phenoxodiol.
Prof Husband said it was possible the different routes could have played a part in the different results. He said the two companies would review the impending phase II triphendiol trial and rethink its protocols, including whether the trial should have oral and intravenous arms.
Prof Husband said Novogen retained the isoflavone platform which showed promise in both oncology and inflammatory disease.
The 2006 interim phase II results presented at the Society of Gynecologic Oncology’s meeting showed that phenoxodiol restored sensitivity to chemotherapy in some women with ovarian, fallopian tube or primary peritoneal cancers (BD: Mar 30, 2006).
Yale Medical School research fellow Dr Michael Kelly said phenoxodiol resulted in “an encouragingly high proportion of tumors either shrinking or stabilizing with standard drugs, when we know that the tumor is unlikely to respond to those standard drugs alone”.
The Yale researchers reported that 74 percent of patients with late-stage, platinum-resistant tumors who received the phenoxodiol and cisplatin showed evidence of a change in tumor growth through tumor shrinkage or no increase in tumor size.
Novogen peaked at $6 in June 2005 and today closed down 21 cents or 53.2 percent at 18.5 cents with 1.6 million shares traded.
* Novogen will be replaced in the Biotech Daily Top 20 by Sunshine Heart and joins the Second 20.
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