And The Early Winner Is…


The American Society of Clinical Oncology’s annual meeting

began this past weekend, and so far the early winner appears to be
Genentech

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on many fronts. The company released full late-phase clinical data on its new
drug Avastin to treat advanced colorectal cancer, and the results look real. Avastin
is a new class of anti-cancer agent that inhibits the growth of new blood
vessels to growing cancers by blocking a protein called Vascular Endothelial
Growth Factor
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. The bottom line was the Avastin-treated patient group
appeared to have a 50% higher survival advantage over the conventional
chemotherapy patient group. This is a significant survival difference
particularly in regard to treating this difficult, advanced cancer. With this
survival difference, the study far exceeded its primary and secondary
endpoints. In addition, the safety profile of the drug was very acceptable. Genentech’s
next step with Avastin is to make preparations for filing with the FDA for
potential approval sometime late this year or early next year.

Along with Avastin, Genentech also
released positive preliminary data on its other targeted drug Tarceva — with
OSI
Pharmaceuticals

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— to treat advanced lung cancer and malignant glioma
(brain cancer). Tarceva, like Avastin, is monoclonal antibody. However, this
drug blocks a different cancer growth stimulant protein called EGF. Genentech is
testing both Avastin and Tarceva against a variety of other cancers with the
hope of broadening the potential use of both drugs. The company also released
preliminary data on a new class of monoclonal antibody (Omnitarg) they’re testing against a variety of solid cancers. With good news coming out of ASCO
and plans in place to market recently approved Xolair for asthma and Raptiva for
psoriasis, Genentech is burning on all cylinders.

ImClone

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also
released much-anticipated data on its new drug, Erbitux. Erbitux has a
mechanism of action similar to Tarceva’s, by blocking a protein (EGF) that
stimulates the growth of cancer cells. ImClone’s data involving the addition of
Erbitux to conventional chemotherapy to treat patients with advanced metastatic
colorectal cancer did show considerable shrinkage of tumors when compared to
conventional chemotherapy alone (23% vs. 11%). However, despite showing efficacy,
overall survival of patients treated with Erbitux was not significantly
influenced. Erbitux also appears to show effectiveness in shrinking tumors in
patients with advanced lung cancer.

Dendreon
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and
Antigenics
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, two companies involved in developing vaccines to treat
cancer, also presented positive early clinical data on their patented
vaccines. The vaccine approach focuses on stimulating the body’s own immune
system to fight off a developing cancer. Dendreon’s vaccine is being tested
against a variety of cancers and appears to have potential in stimulating the
body’s immune system to fight off cancer. Antigenics also presented positive
phase I clinical data on its new vaccine to treat a type of chronic leukemia or
CML. Both companies plan to advance their vaccines into late-stage clinical
trials.

Other less high-profile
companies also presented positive clinical data on their developing cancer drugs
over the weekend at ASCO. Vical
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reported positive phase II results
on its high-dose Allovectin study to treat advanced melanoma. In addition,
Telik
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reported positive phase II results from a study testing its new drug
Telcyta in patients with advanced lung cancer. The company is also testing this
drug in advanced clinical trials against ovarian cancer.


What’s Ahead This Week?


Despite the upbeat weekend presentations, there are several more companies ready
to present data today and tomorrow at ASCO. Look for

Millennium Pharmaceuticals
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to make a big splash today and tomorrow when the company presents
clinical data on the use of its recently approved drug Velcade to treat a
variety of other cancers. Velcade was recently approved by the FDA to treat
multiple myeloma, a fatal bone marrow cancer.

Cell Therapeutics
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and


Medarex
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will also gain some attention this week with presentations
summarizing clinical data on their perspective new cancer drugs.


For the next several days, I believe investors will still be in a
euphoric state over the results coming out of ASCO despite the impressive
anticipatory gains experienced by many of these companies over the last several
weeks.

Good Luck,

Paul Ruggieri MD