Advaxis,
Inc.
February
12, 2009
Page
2
Our goals
over the next few years are to:
1. Initiate
the ADXS11-001 Phase II single blind, placebo controlled trial in pre cancerous
CIN by June 2009. At the conclusion of the first of three dosage arms, we plan
to generate interim efficacy results by December 2010 and complete the final two
arms of the trial by December 2011. This will require additional financing by
May 2009.
2. Apply
for US orphan drug designation for ADXS11-001 in the treatment
of cervical cancer by early March 2009 and initiate a
clinical program for this indication. We expect a response 60 days after
submission, At least one trial sponsored by the Gynecological Oncology Group
(The National Cancer Institute) is anticipated to begin in 2009. We also
anticipate starting studies in countries outside North American and Europe where
advanced cervical cancer remains a major unmet medical
need
.
This is anticipated to be
cheaper than our CIN program, with more funding required by Fall
2009.
3. Once
the above two programs are underway, we will enter our prostate construct
ADXS31-142 (formerly called Lovaxin P) into human clinical trials if sufficient
funds or partnerships are secured.
We plan
to out license the commercial development of ADXS11-001 for the indications of
CIN and cervical cancer. Funds, if obtained, will provide the financial platform
to develop the preclinical and clinical development of prostate construct,
breast cancer construct, and combination constructs which combine specific tumor
antigens and anti-angiogenesis antigens into a single “combination” listeria
vector.
Our plans
might lead to several questions on your part which I would like to address
here:
“Why the new designation of
ADXS11-001 for Lovaxin C?”
Over the past two years, we have seen legal
challenges to the Lovaxin name. Because the FDA will not permit us to use
“Lovaxin” after marketing approval, (marketing brand names have to be completely
new), we will focus company resources to product development and not defending
the Lovaxin name.
“Why we are excited about conducting
a phase II study in CIN?”
The market is very large with an unmet need for
non-surgical treatment that may be superior at a reduced cost. In the US, there
are 250,000 cases of
CIN,
annually. In the US there are the broad scale use of pap smears (about 74% of
women) identifies CIN,
the
pre-invasive stage of cervical cancer. Our therapy could, if successful, avoid
surgery and the frequent complication of an “incompetent cervix” which reduces
the ability to carry unborn children to term.
“Why pursue an orphan drug indication
in cervical cancer?”
While cervical cancer is the number one killer of
women under the age of 45 worldwide, there are only about 5,000 new cases
reported in the US annually. This provides the opportunity to designate cervical
cancer as an orphan drug indication. In the US, therapies that treat
commonly serious diseases that affect less than 200,000 patients are eligible
for designation as orphan drugs. About 50% of applicants for orphan drug status
are granted this status, which confers several advantages: (1) shortened FDA
communication cycles; (2) direct FDA guidance on clinical design; (3) seven year
marketing exclusivity once approved, and (4) eligibility for clinical grants
through the
FDA. Our
aim will be to utilize our orphan drug status (if we are successful) to develop
a clinical plan with FDA for combined phase II/III studies designed to get
approval for use in advanced cervical cancer as quickly as possible. In theory,
we could see approval in as little as 3-3 ½ years, although this is dependent on
FDA agreement to clinical plans which we have not yet submitted.
