14
Society of Hematology. Clinical trials
evaluated the safety and efficacy of as
a single agent and in combination
treatment for multiple myeloma. Stud-
ies are encouraging, and the company
intends to submit new-drug applica-
tion (NDA) to the FDA in 2001.
On December 5, researchers from
Dana-Farber Cancer Institute and
Harvard Medical School presented
data evaluating the activity of Cel-
gene's IMiDs on multiple myeloma
cells. The five abstracts presented
suggest that IMiDs may be beneficial
in the treatment of multiple myeloma.
As a result, initiation of Phase I/II
clinical development of IMiD in mye-
loma patients is underway.
On December 7, Celgene an-
nounced the initiation of a five-year
partnership with the National Cancer
Institute (NCI) for the preclinical and
clinical development of Celgene's Sel-
CIDs (Selective Cytokine Inhibitory
Drugs). SelCIDs are a group of novel,
orally available small molecules that
are anti-angiogenic and potent modu-
lators of tumor necrosis factor-alpha
(TNF-alpha). They selectively inhibit
type-4 phosphodiesterase (PDE-4), a
key class of cell-signaling enzymes
that are linked to the overproduction
of TNF-alpha.
The goal of this research collabo-
ration is to advance the most promis-
ing agents for use in clinical trials.
Pending successful scientific progress,
the National Cancer Institute will
conduct Phase I and Phase II clinical
trials of the most promising SelCID
compounds.
On December 27, the FDA has
accepted the NDA for d-
ethylphenidate (d-MPH), Celgene's
chirally pure version of Ritalin, for
the treatment of attention deficit dis-
order (ADD) and attention deficit hy-
peractivity disorder (ADHD) in
school-age cchildren. It is expected
that the review will be completed in
the third quarter of 2001.
Lately, the
company has had a series of positive
news flow and Thalomid is increas-
ingly becoming accepted in the medi-
cal community, yet the share price
has taken a hit. If Celgene's share
price gets any lower, it's a bargain.
On December 11,
Cell Genesys
(
BSR #25: Gene Therapy) reported
that the company's GVAX prostate
cancer vaccine demonstrated anti-
tumor activity in an initial Phase II
trial in patients with advanced meta-
static prostate cancer who have failed
hormone therapy. As a result, Cell
Genesys plans to initiate further trials
of GVAX prostate cancer vaccine in
2001 employing a higher-potency ver-
sion of the same product. In addition,
this product may be tested in combi-
nation with chemotherapy since future
Phase III trials in hormone refractory
prostate cancer patients may compare
GVAX vaccine in combination with
chemotherapy to chemotherapy alone.
Then on December 20, Cell Ge-
nesys began construction of a multi-
product manufacturing facility that
will meet the clinical production re-
quirements for Phase III studies and
potential product launches. The
41,000 square-foot leased, facility will
be used to manufacture the company's
GVAX cancer vaccines as well as
other gene therapy products, includ-
ing those for hemophilia and cancer.
The facility is expected to be fully
validated and on-line by mid-2002.
A
good sign that product development is
going very well. Lets hope that the
vaccine can show positive results on a
larger scale.
On December 4,
Dendreon (BSR
#45: Prostate Cancer)
presented long-
term follow-up data from Phase II tri-
als of its therapeutic vaccine My-
lovenge at the American Society of
Hematology. The trials, involving pa-
tients with multiple myeloma and
with amyloidosis, indicate that My-
lovenge causes regression or stabiliza-
tion in more than 30 percent of pa-
tients. In some patients, these benefits
were found to extend more than 18
months following treatment.
On December 4, at a medical
conference Roche,
Genentech (BSR
#46: Breast Cancer) and
IDEC (BSR
#19: Lymphoma) presented the in-
terim results from an investigational
Phase III study evaluating the use of
Rituximab in combination with CHOP
(cyclophosphamide, doxorubicin, vin-
cristine and prednisone) chemother-
apy in previously-untreated patients
with chronic lymphocytic leukemia
(CLL) and low-grade non-Hodgkin's
lymphoma (NHL). In this Phase III
study, a majority of the patients dem-
onstrated a significant improvement
in one year.
December 13, Genentech and Ac-
telion signed a licensing accord for
Actelion's Tracleer drug. Under the
deal, Actelion and Genentech will
jointly market and promote Tracleer
BioTech Sage Report, January 2001
