Bio-Path Holdings, Inc., (OTCBB:BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced that it has completed treatment of the first dosage cohort in the Company’s Phase I clinical trial of its lead product candidate, BP-100-1.01 (Liposomal Grb-2), which is a systemic treatment for blood cancers including acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). The trial is being conducted at the MD Anderson Cancer Center. The drug was well tolerated with no treatment-related serious adverse events reported and data suggests some possible anti-leukemia activity.
A total of 14 patients were enrolled in the first cohort of the study. All patients had failed prior therapies. Of the 14 patients, one patient withdrew prior to treatment and 13 were treated. Of the treated patients, six were evaluable and seven failed to complete a full 28-day cycle because of disease progression. Liposomal Grb-2 is systemically delivered by intravenous injection. Patients received a dose of 5 mg/m 2 twice a week for four weeks, for a total of eight doses. Six evaluable patients comprised the completed first dose cohort. Preliminary results suggest that Liposomal Grb-2, at a dose of 5 mg/m 2 is well tolerated. In addition, there is already a suggestion of possible anti-leukemia activity, even at the low starting dose used in the first cohort. The protocol for the clinical trial includes dose escalation of 5, 10, 20, 40 and 50 mg/m 2.
Of the six evaluable patients, lab parameters for blasts and bone marrow demonstrated possible anti-leukemia activity. Two patients had transient improvement and/or stable disease and received a total of five cycles each, representing five months on treatment with the drug. In addition, two patients had transient improvement on leukemia cutis lesions.
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 Plus 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