Head and neck cancer drugs:

Head and neck cancer can arise in the
mouth, throat, larynx, lymph nodes,
sinuses, or other areas in the head or
neck region. According to the National
Cancer Institute, head and neck
cancers account for 3 to 5 percent of
all cancers in the U.S. Approximately
650,000 people are diagnosed with
squamous cell cancer of the head and
neck worldwide each year. An
estimated 350,000 people die from the
disease annually.

CEL-SCI Corporation is developing
products that empower immune
defenses. Its lead product is Multikine.

Multikine is the first of a new class of
cancer immunotherapy drugs called
Immune SIMULATORs. It simulates the
activities of a healthy person's immune
system, which battles cancer every
day. This therapy is similar to
Dendreon's  blockbuster prostrate
drug, Provenge.

Teva Pharmaceuticals  is CEL-SCI's
partner on Multikine.

In Phase II clinical trials Multikine was
shown to be safe and well-tolerated,
and to eliminate the tumors in 12% of
the patients after only three weeks of
treatment. Follow-up showed an
improvement in the survival rate of
those patients treated with Multikine of
33% at a median of three and a half
years following surgery. Results of the
trial also showed that the treatment
regimen killed, on average, about half
of the cancer cells before the start of
standard therapy like surgery,
radiation and chemotherapy. The U.S.
Food and Drug Administration gave
the go-ahead for a Phase III clinical
trial and granted orphan drug status to
Multikine in the neoadjuvant therapy of
patients with squamous cell carcinoma
of the head and neck.

BioVex Inc  announced that the data
from its completed Phase I/II clinical
study of OncoVEXGM-CSF for the first
line treatment of head and neck
cancer is  published in the journal
Clinical Cancer Research.

Doctors in London successfully used a
genetically engineered version of the
herpes virus to treat head and neck
cancer in a small clinical trial of 17
patients. The virus, known as
OncoVEX, was injected into the cancer-
affected lymph nodes of 17 patients.
Patients were given up to four doses of
the virus in combination with
chemotherapy and radiotherapy. The
study was conducted by the Institute of
Cancer Research and the Royal
Marsden NHS Foundation Trust.

Of the group, 82.3 percent of patients
experienced apparent tumor
shrinkage. About 93 percent of
patients showed no residual cancer in
their lymph nodes following
subsequent surgery to remove them.
After 29 months, 82.4 percent of
patients were still alive. Only 2 of 13
patients who were given high doses of
the virus relapsed.

OncoVEX, developed by
Massachusetts-based biotechnology
company BioVex, was engineered to
multiply inside cancer cells while
sparing healthy cells. Once inside, the
virus would multiply and burst, killing
the cancer cell. OncoVEX was also
formulated to stimulate an immune
response by producing a human

Erbitux by Eli Lilly and Merck KGaA
The drug is approved to treat head,
neck and colon cancer.

Boehringer drug  BIBW 2992 as
effective as Erbitux in head-and-neck
Boehringer Ingelheim says that data  
shows that the company’s BIBW 2992
shrank tumors in 22% of patients with
head and neck cancer (measured as
partial response), compared to 13% of
those receiving Erbitux.
BIBW 2992 – a small molecule which
targets the epidermal growth factor
receptor (EGFR/HER1) and human
epidermal receptor 2 (HER2) tyrosine
kinase – works by irreversibly binding
to the receptor, unlike available
treatments in this class. The drug is in
an an ongoing Phase II trial.
Recurrent head and neck cancer
carries a very poor prognosis, and this
is truly the first time that an oral EGFR
targeting agent has shown this level of
activity, says the company.

Canadian company Oncolytics is now
gearing up to start its first Phase 3  
study with Reolysin in patients with
advanced head and neck cancer at 25
centres in Britain and the U.S., under a
special protocol assessment from the
FDA, with plans to expand to Belgium,
for multijurisdictional approval in
Europe and Canada.
Reolysin will be tested in combination
with two chemotherapy drugs,
paclitaxel and carboplatin, versus
chemotherapy alone in a two-stage
clinical trial. The first stage is designed
to enroll 80 patients. The second
stage is adaptive, and designed to
enrol between 100 and 400 patients,
with the most probable statistical
enrollment now being 200 patients.
The company expects to complete
enrollment of 80 patients by this
Christmas and release some initial
data next spring or summer. The
primary endpoint is overall survival,
with key secondary endpoints including
progression free survival, response
rate and duration of response, as well
as safety.

Nanospectra Biosciences, which is
developing its AuroLase cancer
therapy for the destruction of solid

Curis recently announced that it had
dosed its first patient in a Phase Ib
expansion study for CUDC-101 in
patients with advanced head and neck,
gastric, breast, and liver cancers.
CUDC-101 is a small-molecule drug
designed to inhibit three molecular
targets in the cancer pathway that may
allow cancer to grow and spread.