SAN FRANCISCO, CA, September 19, 2000
- Dr. Raymond P. Warrell, Jr., President and CEO of Genta
Incorporated (Nasdaq:
GNTA
), presented an update of the Company"s ongoing clinical trials,
along with plans for future registration studies that the Company
expects to initiate over the next six months. In addition, Dr.
Warrell fielded several inquiries related to the Company"s recent
profile in the September 18th issue of Forbes magazine. The update
was included in remarks delivered this week at the Anticancer
Biopharmaceuticals conference in San Francisco sponsored by
Stephens Inc., an investment banking firm.
As discussed at the conference, patient accrual to the Company"s
ongoing Phase 3 trial of Genasense
TM
, Genta"s lead antisense drug, in malignant melanoma remains on
target for completion by mid-summer 2001. Dr. Warrell noted:
"Long-term survival of patients in the original Phase 1-2 study now
exceeds a median of one year, which is the principal focus of both
the FDA and our Phase 3 trial." The peer-reviewed report from the
phase 1-2 Study has been accepted for publication in The Lancet, a
leading biomedical journal.
Following completion of the strategic review of its clinical
development program over the summer, the Company identified the
next series of registration studies it proposes to undertake. As
noted at the conference, these trials will include multiple
myeloma, chronic lymphocytic leukemia (CLL) and acute myelocytic
leukemia (AML). The Company expects to initiate the myeloma study
before the end of the year, and expects to have all four of its
top-tier registration studies ongoing in the first quarter of 2001.
Dr. Warrell noted: "These diseases all markedly over-express Bcl-2,
the protein against which Genasense
TM
is targeted. Moreover, myeloma and CLL are cancers of
malignant lymphocytes, for which there is substantial evidence of
both single-agent and combination activity. Finally, both the
myeloma and AML studies will employ combination drugs
(dexamethasone and a monoclonal antibody drug conjugate) that are
perceived by both physicians and patients as being "not
chemotherapy", a concept that we"ve found has wide appeal."
"Preliminary results from the Company"s studies in prostate
cancer will be presented in November at the joint NCI/EORTC
meeting," continued Dr. Warrell. "The rapid accrual and exciting
results of our combined Genasense
TM
/Taxotere
TM
(docetaxel; Aventis Inc.) study, along with studies conducted
by NCI investigators in AML, colon cancer and lung cancer, are
extremely gratifying."
Finally, Dr. Warrell observed that the Company"s profile in the
recent issue of Forbes has been exceptionally well received. (The
article can be accessed at:
http://forbes.com/forbes/00/0918/6608224a.aspx
. "As noted in the Forbes article, the singular attractiveness of
Bcl-2 as a cancer target has not gone unnoticed by competitors,
which we regard as further validation of our scientific approach.
To date, however, we do not believe any small molecule attack on
Bcl-2 has been successful. The Genasense
TM
antisense strategy yields a highly selective knockout of
Bcl-2. Alternative approaches, such as 3-D structural or
combinatorial designs, inevitably yield compounds that later have
unpredictable side effects in vivo. Genta has years of lead-time,
as well as extensive clinical experience, in exploiting the
"pro-apoptotic" strategy in clinical trials, and we expect to
rapidly widen that commanding position."
