t**u
发帖数: 1572 | 1 shit, I just buy 1600 share this morning.
Delcath Announces Updated Efficacy Results From Phase 3 Trial of
Chemosaturation for Melanoma Metastases in the Liver Presented at European
Multidisciplinary Cancer Congress
Delcath Systems (NASDAQ:DCTH - News) announced today that James F. Pingpank,
MD, FACS, Associate Professor of Surgery at the University of Pittsburgh
School of Medicine, will present updated investigator results from the Phase
3 randomized trial of Delcath's chemosaturation system with melphalan in
patients with hepatic metastases from ocular or cutaneous melanoma.
Dr. Pingpank, a lead principal investigator of the Phase 3 trial, will
present the abstract (9304), "Percutaneous Hepatic Perfusion (PHP) vs. Best
Alternative Care (BAC) for Patients with Melanoma Liver Metastases -
Efficacy Update of the Phase 3 Trial," in the plenary session today at 11:
15am CEST at the European Multidisciplinary Cancer Congress in Stockholm.
These updated results include follow-up data from patients through March
2011, an additional 12 months of data maturation from when Dr. Pingpank
first presented investigator data from this Phase 3 trial in June 2010, at
the American Society of Clinical Oncology's Annual Meeting.
With respect to the study's primary endpoint of hepatic progression free
survival ("hPFS"), the updated investigator-assessed results showed that
patients in the chemosaturation arm demonstrated median hPFS of 8.0 months
compared to 1.6 months in the BAC arm, a significant 6.4 month extension of
hPFS (hazard ratio 0.35, p<0.0001). Median overall PFS in the
chemosaturation arm was 6.7 months compared to 1.6 months in the BAC arm, an
increase of 5.1 months (hazard ratio 0.36, p<0.0001).
As reported previously, the hepatic response rate in the chemosaturation arm
was 34% compared to 2% for the BAC arm. In addition, 52% of patients in the
chemosaturation arm achieved stable disease, compared with 27% in the BAC
group, giving a tumor growth control rate of 86% for the chemosaturation
group versus 29% for the BAC group (p<0.001). Patients who crossed from the
BAC arm to chemosaturation treatment after progression of liver disease
showed consistent efficacy with patients treated on the chemosaturation arm.
As expected, there was no difference in overall survival in the randomized
study due to the crossover trial design. An analysis of survival trends by
patient cohorts indicated that patients treated with chemosaturation,
including crossover patients, had a median survival of 11.4 months compared
to 4.1 months for BAC patients who did not receive chemosaturation. As of
June 30th, 11 patients treated with chemosaturation were still alive
compared to two patients in the BAC arm who did not receive chemosaturation.
"The additional 12 months of data and extended survival for a significant
percentage of the treated patients confirm our belief that chemosaturation
may provide a significantly better option than the few treatments presently
available for patients with melanoma metastases in the liver," said Eamonn P
. Hobbs, President and CEO of Delcath. "The hepatic PFS, overall PFS and
response rate are consistent with past investigator assessments and highly
statistically significant. We are encouraged by the data presented in
Stockholm today." | t**u
发帖数: 1572 | 2 Close price 3.41.
The price after closing 3.9x
Pingpank,
Phase
【在 t**u 的大作中提到】
: shit, I just buy 1600 share this morning.
: Delcath Announces Updated Efficacy Results From Phase 3 Trial of
: Chemosaturation for Melanoma Metastases in the Liver Presented at European
: Multidisciplinary Cancer Congress
: Delcath Systems (NASDAQ:DCTH - News) announced today that James F. Pingpank,
: MD, FACS, Associate Professor of Surgery at the University of Pittsburgh
: School of Medicine, will present updated investigator results from the Phase
: 3 randomized trial of Delcath's chemosaturation system with melphalan in
: patients with hepatic metastases from ocular or cutaneous melanoma.
: Dr. Pingpank, a lead principal investigator of the Phase 3 trial, will
| c**t
发帖数: 2889 | 3 Con~
Pingpank,
Phase
【在 t**u 的大作中提到】
: shit, I just buy 1600 share this morning.
: Delcath Announces Updated Efficacy Results From Phase 3 Trial of
: Chemosaturation for Melanoma Metastases in the Liver Presented at European
: Multidisciplinary Cancer Congress
: Delcath Systems (NASDAQ:DCTH - News) announced today that James F. Pingpank,
: MD, FACS, Associate Professor of Surgery at the University of Pittsburgh
: School of Medicine, will present updated investigator results from the Phase
: 3 randomized trial of Delcath's chemosaturation system with melphalan in
: patients with hepatic metastases from ocular or cutaneous melanoma.
: Dr. Pingpank, a lead principal investigator of the Phase 3 trial, will
| y***q
发帖数: 4147 | 4 re
【在 t**u 的大作中提到】
: Close price 3.41.
: The price after closing 3.9x
:
: Pingpank,
: Phase
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