Skin cancer:

Skin cancer is the uncontrolled growth
of abnormal skin cells. If left
unchecked, these cancer cells can
spread from the skin into other tissues
and organs.

There are different types of skin
cancer. Basal cell carcinoma is the
most common. Melanoma is less
common, but more dangerous.

In November 2011 Curis, Inc.
announced that the FDA has
accepted  for review Genentech’s new
drug application for Vismodegib for the
treatment of adults with advanced
basal cell carcinoma (BCC) for whom
surgery is considered inappropriate.
Action may be taken  by the FDA is
early March 2012.

As part of a milestone payment
agreement from Genentech, Curis
earned an $8 million upon the FDA’s
acceptance of the NDA submission.

This particular application is based on
clinical data from a pivotal Phase II
study of vismodegib in patients with
advanced basal cell carcinoma.

The drug candidate, which is first-in-
class, investigational, oral medicine
designed to selectively inhibit signaling
in the Hedgehog pathway and is being
developed by Genentech, a member of
the Roche group, under a
collaboration agreement with Curis.

The drug candidate presents a
substantial market opportunity since
basal cell carcinoma is the most
common cancer in the United States
and the most common type of skin
cancer. There are approximately two
million new cases annually.

The disease is generally considered
curable when the cancer is restricted
to a small area of the skin. However, in
a small group of people, if the disease
is left untreated or does not respond to
treatment, the cancer may advance
further into the skin, bones or other
tissues, or spread to other parts of the
body. In such rare cases, the disease
can become difficult to treat and life-

GDC-0449 might be one of many
cancer drugs in the pipeline at
Genentech, but for its partner
Lexington, MA-based Curis  this drug
is the most advanced compound in its

In March 2011, Curis announced that
Genentech's Phase II study of the drug
in inoperable BCC patients met its
primary goal of shrinking tumors of a
certain percentage of patients.

This was good news after the drug
flunked in mid-stage studies
Genentech conducted in patients with
ovarian and colorectal cancers last

Basal cell carcinoma (BCC) is the most
common skin cancer in humans, yet it
accounts for less than 0.1% of patient
deaths due to cancer. Basal cell skin
cancer tumors typically appear on sun-
exposed skin, are slow growing, and
rarely metastasize.

photodynamic therapy;

MOHS micrographic surgery;

Skin patch which delivers the
radioactive phosphorus-32 for basal
cell carcinoma is possible alternative to

Glowing plaster by Polymetronics (UK)
in trial;