QUÉBEC CITY, Nov. 19, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that perifosine, its oral AKT inhibitor, combined with temsirolimus ("TEM"), was well tolerated in an investigator driven Phase 1 clinical trial in recurrent or progressive malignant glioma ("MG"). Data were presented over the weekend by Thomas J. Kaley, MD, Director, Neuro-Oncology Fellowship Program at Memorial Sloan-Kettering Cancer Center, during a poster session at the Society of Neuro-Oncology annual meeting in Washington D.C.
The trial involved 32 patients with recurrent or progressive (glioblastoma (16), anaplastic astrocytoma (7), anaplastic oligodendroglioma (7), and transformed low-grade gliomas (2)), with median Karnofsky Performance Status ("KPS") 80 (range, 60-100). Twenty-one patients were refractory to bevacizumab or other anti-VEGF/VEGFR therapy. The dose of TEM was escalated in each cohort using standard 3 + 3 design from 15 mg to 170 mg administered once weekly. The dose of perifosine was a 600 mg loading dose on day 1, followed by a 100 mg nightly dose, for dose level 1 through dose level 6. At dose level 7, the loading dose was increased to 900 mg, followed by a 100 mg nightly dose.
ResultsThe trial is currently accruing to dose level 5 (115 mg) after 2 dose-limiting toxicities ("DLT") in the dose level 7 (170 mg) and dose level 6 (170 mg) expansion cohorts. Maximum tolerated dose ("MTD") was not defined. Thirty-one patients were evaluable for toxicity. There were 5 DLTs: thrombocytopenia (3), intra-cerebral hemorrhage (1), and lung infection (1). Only one grade 4 toxicity (thrombocytopenia) was reported. Most frequent grade 3 non dose-limiting hematologic toxicities were lymphopenia (7), hyperglycemia (4), lung infection (4), and hypophosphatemia (3). Notable grade 2 toxicities were hypophosphatemia (14), hypocholesterolemia (13), and hypertriglyceridemia (11).
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV