Preliminary
Phase I/II Trial Results for Cotara
June 26, 2001
Peregrine Pharmaceuticals announced
preliminary results from a Phase I/II clinical trial of its drug/agent
Cotara (involving Tumor Necrosis Therapy as a radiolabeled monoclonal
antibody) against solid malignant tumors -- that related to findings
as presented at the 48th annual meeting of the Society of Nuclear
Medicine in Toronto, June 23-27. Cotara was reported as “well
tolerated,” and positive tumor responses were noted in one
prostate cancer patient (“stable disease”) and in one
pancreatic cancer patient (“significant shrinkage of the
tumor”).
Phase
I Trial with Irofulven / Gemcitabine for Advanced Cancers
June 25, 2001
MGI Pharma has announced the
initiation of a dose-escalation Phase I clinical trial with irofulven
in combination with gemcitabine for the treatment of advanced
cancers.
Pegfilgrastim
Submitted to FDA for Approval
June 22, 2001
Amgen, Inc. is seeking approval
from the FDA for the commercial release in the U.S. of its agent
pegfilgrastim (SD/01) for the treatment of neutropenia (low white
blood cell count) seen in myelosuppressive chemotherapy and HIV
infection. Pegfilgrastim is the polyethylene glycol conjugated
form of granulocyte-colony stimulating factor.
Phase
II Trial with BBR 3464 Against Pancreatic Cancer
June 21, 2001
Novuspharma announced that patient
accrual has begun for a Phase II clinical trial with its agent
BBR 3464 for the treatment of advanced pancreatic cancer. BBR
3464 is a unique compound which carries a tri-platinum complex.
The study will occur at Virginia Commonwealth University in Richmond,
Virginia; it will enroll up to 50 patients who have not been
previously treated with chemotherapy.
Phase
I Trials Announced: LDP-341 with Gemcitabine and with Irinotecan
June 14, 2001
Millennium Pharmaceuticals has
announced the launch of two combination Phase I trials through
the Dana Farber/Partners CancerCare (a collaboration with Massachusetts
General Hospital, Brigham and Women’s Hospital and the Dana-Farber
Cancer Institute) with its agent LDP-341 (formerly PS-341) whose
mode of action is as a small molecule proteasome inhibitor. The
one trial will study LDP-341 and gemcitabine against advanced
solid tumors, with a focus on pancreatic and lung cancers. The
other trial will study LDP-341 and irinotecan against previously
treated advanced solid tumors, with a focus on gastrointestinal
cancers including colorectal cancer.
Increased
Longevity Reported with Chemotherapy Combination (PEF-G)
June 7, 2001
Italian researchers have reported
findings in the May 15th issue of the Journal of Clinical Oncology
(pps. 2679-2686) whereby a regimen of cisplatin, epirubicin,
5-FU and gemcitabine (collectively, PEG-F) conferred a median
survival duration of 11 months to 49 patients with Stage IV pancreatic
adenocarcinoma -- much longer than expected. The authors indicate
that this regimen appeared to be “safe” and “well-tolerated,”
although neutropenia, anemia and thrombocytopenia were very common.
This kind of aggressive chemotherapy dosing has, until recently,
generally been thought to have no place in the treatment of advanced
pancreatic cancer, according to the authors. A larger Phase III
study of this regimen is planned, with PEF-G as one arm of the
trial and gemcitabine as the other.
Early
Ifosfamide Results Reported as Favorable
June 6, 2001
Researchers from Austrian Nordic
Biotherapeutics reported the results of a Phase I/II clinical
trial with their agent ifosfamide (CYP2B1) as delivered via angiography
to tumor vasculature in micro-encapsulated form to 14 patients
with Stage III and IV pancreatic adenocarcinoma in a Research
Letter in the May 19th, 2001 issue of the Journal Lancet
(pps. 1591-1592). Four patients appeared to show tumor regression,
while eight appeared to show stable disease. The median survival
time was 10 months for those treated with the ifosfamide as compared
to 5 months against a roughly equivalent control group (mainly
stage IV disease) treated with standard therapies. This ifosfamide
chemotherapy regimen was reported as “well tolerated.”
The treatment is being further tested in a current Phase II trial.
Early
Ras Vaccine Results Reported as Encouraging
June 5, 2001
Norwegian researchers in the
May 1, 2001 issue of the International Journal of Cancer
(pps. 441-450) have reported out the results of a Phase I/II
study whereby those pancreatic cancer patients with advanced
disease who demonstrably responded (with peptide-specific immunity)
to a regimen of an intradermal injection administered Ras vaccine
PLUS (as adjuvant) granulocyte-macrophage colony-stimulating
factor (25 of 43 evaluable patients), appeared to demonstrate
increased median survival as compared to vaccine non-responders
(148 days vs. 61 days). The vaccine was reported as well tolerated;
and biopsy and subsequent testing appeared to show that activated
Ras-specific T cells had selectively accumulated in the tumor
itself.
ISIS
2503 Phase II Results Reported
May 31, 2001
The results of a multi-center
Phase II clinical trial with the Isis antisense oligonucleotide
ISIS 2503 against advanced pancreatic cancer, were reported at
the recent annual ASCO meeting. In 16 evaluable patients, two
were found to have stable disease and 14 with progressive disease.
SCH
66336 Phase II Results Reported
May 31, 2001
The results of a Phase II clinical
trial comparing the Schering Plough farnesyl protein transferase
inhibitor SCH 66336 (33 patients) with Lilly’s gemcitabine
(30 patients) against pancreatic cancer, were reported at the
recent annual ASCO meeting. Overall survival for SCH 66336 was
found to be 3.3 months with two partial responses and six patients
with stable disease; with gemcitable these figures were 4.4 months
with one partial response and eleven patients with stable disease.
CP461
to Enter Phase I Trials in Combination with Gemcitabine
May 23, 2001
At this year's annual meeting
of ASCO, Cell Pathways, Inc. announced the results of a Phase
I clinical trial of its agent CP461, which acts against the cyclic
GMP phosphodiesterase 5 (PDE5) thus triggering apoptosis (programmed
cell death) selectively in cancer cells. The PDE5 enzyme appears
to be strongly over-expressed in pancreatic carcinoma, according
to further research presented this week at the annual meeting
of the American Gastroenterological Association. Based on these
results, Cell Pathways plans to evaluate CP461 in Phase II clinical
trials in cancer patients as a single agent, and in a phase I
study in combination with gemcitabine against pancreatic cancer.
Caution
Advised with Irinotecan, Fluorouracil and Leucovorin Combination
May 17, 2001
Researchers from the Mayo Clinic
and Duke University have issued an early caution in a letter
to the New England Journal of Medicine, reporting an unexpectedly
high rate of death associated with the combination of irinotecan,
fluorouracil and leucovorin against colorectal cancer in approved
dosages in two separate NCI-sponsored cooperative group clinical
trials.
Results
of Anti-Gastrin 17 Immunogen Study
May 15, 2001
Apthon announced that clinical
trials conducted in England with its immunogen agent anti-gastrin
17, demonstrated an increased survival duration as compared with
gemcitabine. This agent is currently in Phase III clinical trials
against advanced pancreatic cancer in the U.S. and in Europe.
Pharmacyclics
Reports Interim Phase I/II Results of Xcytrin
May 14, 2001
The results of an interim Phase
I/II clinical trial against advanced unresectable biliary tree
and pancreatic cancers by the Pharmacyclics Inc. agent Xcytrin
(motexafin gadolinium) including attendant radiation, were reported
at this year's annual ASCO meeting. This study is now proceeding
to Phase II status.
Anti-CEA
Vaccines (ALVAC-CEA & Vaccinia-CEA) Phase I/II Results
May 14, 2001
The results of a Phase I/II clinical
trial of two Anti-CEA vaccines (ALVAC-CEA and vaccinia-CEA) against
late-stage metastatic cancers which expressed CEA tumor antigen
as developed by Therion Biologics in collaboration with the NCI
and Aventis Pasteur, were reported out at this year's annual
ASCO meeting as holding "promise" by John Marshall,
MD of Georgetown University Medical Center, the study's principal
investigator. Based on these findings, Therion and Georgetown
will initiate Phase II trials.
Phase
I Results of ABX-EGF Reported
May 14, 2001
The results of an interim Phase
I clinical trial against solid tumors (including pancreatic cancer)
of the EGFR inhibitor ABX-EGF as jointly developed by Abgenix,
Inc. and Immunex Corporation were reported at this year's annual
ASCO meeting.
Phase
I Results of BAY 43-9006 (Onyx & Bayer)
May 14, 2001
The results of an interim Phase
I clinical trial against refractory solid tumors (including pancreatic
cancer) of the their oral Raf kinase inhibitor known as BAY 43-9006,
as jointly developed by Onyx Pharmaceuticals and the Bayer Corporation,
were reported as "encouraging" at this year's annual
ASCO meeting. Raf kinase is an enzyme in the ras gene signaling
pathway.
Results
of Phase I/II Study of huC242-DM1/SB-408075
May 13, 2001
Results of a Phase I/II safety
and pharmacokinetic study of the Tumor-Activated Prodrug (TAP)
huC242-DMI/SB-408075 against solid tumors including four patients
with pancreatic cancer, were presented at the annual ASCO meeting
and announced by ImmunoGen, Inc. as well-tolerated.
Phase
III Studies to Begin for Tarceva (OSI-774)
May 13, 2001
OSI Pharmaceuticals announced
that the results of a Phase II study of Tarceva, an inhibitor
of epidermal growth factor receptor (EGFR), showed "encouraging"
results, and indicated that Phase III studies would begin within
months against late-stage lung and pancreatic cancers.
Phase
II Findings of IMC-C225 Against Pancreatic Cancer
May 13, 2001
ImClone Systems Incorporated
announced that the findings of a phase II combination study with
its agent IMC-C225 (a EGFR inhibitor) together with gemcitabine
against pancreatic cancer (40 patients) demonstrated a 32.5 percent
one-year survival rate. The company indicates that it intends
to begin Phase III trials with this combination in late 2001.
Single-dose
Pegfilgrastim Shows Promise in Combating Neutropenia
May 12, 2001
Amgen, Inc. has reported results
of Phase III clinical trial data today at the annual ASCO meeting
which suggest that single dose injection of its investigational
agent pegfilgrastim (SD/01) is as “safe and effective”
in decreasing the duration of severe neutropenia (reduced white
blood cell count) related to certain chemotherapy as is the drug
Neupogen (filgrastim) which can require up to two weeks of daily
injections.
Troxatyl
Evaluated For Pancreatic Cancer
May 10, 2001
BioChem Pharma announced that
its agent Troxatyl (troxacitabine), in addition to hematologic
malignancies, is being evaluated as a single agent against pancreatic
cancer and in combination therapy in solid tumors. Troxatyl is
the first dioxolane nucleoside analog to be investigated as an
anticancer agent.
Avicine
Vaccine Phase II Results Against Pancreatic Cancer
May 10, 2001
Interim results of a Phase II
ongoing study of AVI BioPharma's anti-(beta)-HCG peptide vaccine,
Avicine, alone vs. in combination with gemcitabine against 55
patients with pancreatic cancer were reported as "encouraging."
Gemcitabine
Featured in Many Scientific Papers At ASCO
May 9, 2001
Eli Lilly and Company has announced
that its agent gemcitabine will be featured in more than 200
scientific papers at this year's annual ASCO meeting.
K-ras
Oncogene Can be Activated in New Mice Model
April 25, 2001
As reported in the upcoming journal
Nature, investigators at the Massachusetts Institute of Technology,
under the aegis of the Mouse Models of Human Cancer Consortium
as funded by the National Cancer Institute, have genetically
engineered a cancer-prone breed of mice in which mutated K-ras
oncogenes are activated in random cells via spontaneous recombination
- tending to mimic the sporadic occurrence of K-ras mutations
which is seen in many human cancers (and in over 90% of pancreatic
adenocarcinomas). This breakthrough is hoped to be useful for
study related to a number of cancers.
Phase I
Trial of Cotara to Begin at Stanford
April 12, 2001
Peregrine Pharmaceuticals announced
that its agent, the radio-labeled monoclonal antibody 131 I-chTNT-B
(Cotara), which acts by binding to the necrotic core of tumors,
will undergo phase I testing at Stanford University.
Dietary
Folate May Decrease Smokers' Risk of Pancreatic Cancer
April 11, 2001
A prospective
Finnish study, as reported in the American Journal of Epidemiology,
indicated that among older male cigarette smokers an increased
level of dietary folate intake appeared to be associated with
a reduction in the risk of acquiring exocrine pancreatic cancer.
It was postulated that these results will likely also apply to
women in future studies.
Metformin
Prevents Pancreatic Cancer in Hamsters
April 10, 2001
Researchers from the University
of Nebraska reported in a recent edition of the journal Gastroenterology
that the drug agent metformin, which acts by improving insulin
resistance, appeared to block pancreatic adenocarcinoma formation
in hamsters which were given a carcinogen.
IMC-C225
in Phase II Trials / ImClone Receives U.S. Patent
April 5, 2001
ImClone reports that its agent
IMC-C225, a monoclonal antibody which an anti-EGFR (Epidermal
Growth Factor Receptor), in concert with other standard chemo-therapeutic
therapies, is currently involved in a number of Phase II trials
against various solid tumors including that of pancreatic cancer.
It is also in a Phase III trial against head and neck carcinoma.
Recently ImClone received U.S. patent protection for this agent.
BBR 3464
to Begin Phase II Study
April 4, 2001
The Italian biotech firm Novuspharma
indicated that its novel platinum compound BBR 3464 will soon
commence phase II trials against pancreatic cancer in the U.S.
GBC-590
Phase IIa Clinical Trials ongoing
April 4, 2001
SafeScience, Inc. announced that
phase IIa clinical trials of GBC-590, a carbohydrate lectin inhibitor,
against pancreatic cancer are ongoing and that full enrollment
is soon expected.
|
