| December
10th 2002. Last week Millennium announced that the company plans
to submit a new drug application (NDA) to the Food and Drug
Administration (FDA) to market its anti-cancer drug Velcade based
on the final results from Phase II patient testing.
The company released those results from patients with
relapsed/refractory multiple myeloma on Monday, December 9th
at the American Society of Hematology (ASH) meeting. The
presentation reported the clinical usage of Velcade in two
different studies for multiple myeloma patients, those in the
advanced stages and the other whose cancer had relapsed or become
refractory to conventional treatment.
The study investigators and
Millennium provided important statistics in the clinical profile
of Velcade that confirmed the response rate observed in the
initial Phase II Velcade multiple myeloma study. Based on 193
evaluable patients, Velcade
demonstrated compelling anti-cancer activity with 59% of patients
achieving a partial response or disease stabilization, and 35%
exhibiting an overall response defined as complete, partial or
minor response. The median survival for patients was 16.4 months,
and the median duration of response for the complete and partial
response population was 12 months. The second part of the study
was the safety data. Side effects were not limited to
nausea, vomiting and diarrhea. Peripheral neuropathy,
thrombocytopenia, neutropenia and anemia were reported in patients
as well. Given that this patient population has no other
alternative for treatment, the results are very good.
Unfortunately, 21% of the patient population discontinued the
therapy because of side effects.
In another clinical trial, referred
to as the CREST study, Velcade was evaluated in 54 patients with
multiple myeloma whose disease had relapsed after front-line
therapy. The study also evaluated Velcade in the presence of other
chemotherapy agents when Velcade was insufficient alone at two
distinct doses. In one study the overall response rate was 50% for
both complete and partial remission. However, in those patients
who were not responding to Velcade, chemotherapy was added and the
overall response rate increased to 62%, with 69 % of patients
experiencing stabilization of their disease. In the second study,
the overall response rate was 33% and combined with a
chemotherapy, rate increased to 44%. In general, 59 % of patients
experience stabilization of their disease. Thus, the results from
these two studies indicate that Velcade can function
synergistically with conventional chemotherapy when Velcade or
conventional therapy alone is not sufficient.
Velcade gained FDA
"fast-track" status, which means it could be approved
six months after the application is submitted. Millennium plans to
submit the NDA within the next few months to market Velcade as a
treatment for relapsed/refractory multiple myeloma under a sub
part H filing with the FDA. In other words, as long as Millennium
can provide clinical studies that are well controlled and
adequate, and support it with a larger random trial than the FDA
may approve Velcade. Millennium is currently evaluating Velcade in
a Phase
III clinical study that began accruing patients in July. According
to the company, the study is on track and will be completed. Given
the newly released data, we foresee Velcade having a good chance
of success.
Velcade is a novel proteosome
inhibitor and is being evaluated as a single agent and in
combination with other anti-cancer agents for a variety of
different malignancies. Velcade appears to work by causing cancer
cells to self-destruct, and has good potential to be used in other
cancer types.
Even though we feel the news is
encouraging for Millennium’s Velcade, Millennium shares traded
down as the investing community frets over Millennium’s strategy
of using Phase II data to gain FDA approval and the whether
Velcade’s side effect and the drop out rate are serious enough
for concern. After weighing all the factors, we believe Millennium
has potential and will receive FDA approval.
Another biotech company that has
been in limelight of late is ISIS Pharmaceuticals. As you may have
read, the investment community is trying to understand the
company’s Affinitac, an anti-sense drug that is in Phase III
clinical trials for the treatment of non-small cell lung cancer.
Wall Street analysts are guessing the outcome of the Phase III
clinical trials, with some speculating that the drug will not show
clinical benefit. For those investors hoping Affinitac will be
successful, it was comforting to hear ISIS’ CEO vehemently
defending Affinitac. Meanwhile, investors will have to wait until
March 2003, when the trial is unblinded and the clinical data
released. If the data is compelling and without ambiguity, look
for ISIS to file an NDA to the FDA. Anti-sense has made progress
for the better and eventually will have successes. Investors will
need patience.
Velcade and Affinitac are
complicated stories and pose a challenge for investors to
understand the companies’ technology and value. Our mission is
to help investors interpret the news and make a profit.
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