New Data on Antisense Mechanism and Clinical Response
Reported in Leading Journal
BERKELEY HEIGHTS, NJ, November 17, 2000
- Genta Incorporated (Nasdaq:
GNTA
) announced today that researchers reported that Genasense
TM
, the Companys lead antisense compound, reduced levels of Bcl-2
protein, caused major antitumor responses, and possibly extended
the life of patients, when used in combination with dacarbazine
(DTIC). The report was published in the November 18th issue of the
premiere international biomedical journal, The Lancet.
The Phase 1-2 study, which involved 14 patients with advanced
Stage IV melanoma, reported highly encouraging rates of durable
response and survival. At entry, most patients had progressive
metastatic disease and had failed conventional treatment. Antitumor
responses were noted in 6 of the 14 evaluable patients (43%),
including a pathologically confirmed complete response in a 90-year
old woman with metastatic disease. Two additional patients also
demonstrated stabilization of disease.
The median survival of all patients had exceeded one year at the
time the report was written. According to the authors, these
results compare favorably with negligible response rates and median
survival rates of 4-5 months in similar patients who have failed
first-line systemic therapy. Down-regulation of the Bcl-2 protein,
the biological target of Genasense, was seen in 10 of 12 evaluable
patients (83%). The maximum decrease occurred by day 5 of
treatment. Furthermore, Genasense was well-tolerated and showed no
important additive side-effects. The article can be viewed at:
http://www.thelancet.com/
.
"Few patients obtain long-term benefit from current melanoma
regimens, and it is clear that new treatment approaches are
necessary," said Dr. Burkhard Jansen, lead investigator in this
study. "We have now documented that systemic treatment with
Genasense
TM
can down-regulate Bcl-2 in solid tumors. Combined with
standard chemotherapy, this approach opens up an entirely new
direction for treatment of patients with resistant cancers. We are
very encouraged by results seen thus far."
Dr. Howard Fingert, Gentas Vice-President of Clinical
Operations, noted, "Most patients in this trial had been
unsuccessfully treated with other anticancer agents. To see this
level of activity is therefore quite promising as we continue with
our Phase 3 registration study of this combination in
melanoma."
