K E N N E T H I. D E N O S, P. C.
================================================================================
10757 SOUTH, RIVER FRONT PARKWAY, SUITE 125
SOUTH JORDAN, UTAH 84 095
(801)816-2511
FAX:(801) 816-2599
KDENOS@DENOSLAW.COM
April 25, 2006
VIA FEDERAL EXPRESS
Mr. Jay Ingram
Mr. John Reynolds
U.S. SECURITIES AND EXCHANGE COMMISSION
Division of Corporate Finance
Office of Emerging Growth Companies
450 Fifth Street, N.W., Mail Stop 0511
Washington, D.C. 20549
Telephone (202) 942-2791
Facsimile (202) 942-9516
Re: Cancer Therapeutics, Inc.
Registration Statement on Form SB-2
File No. 333-119915
Amendment Filed: April 25, 2006
Dear Messrs. Ingram and Reynolds:
This firm serves as counsel to Cancer Therapeutics, Inc. in connection
with its submission of a registration statement with the Securities and Exchange
Commission on Form SB-2. We acknowledge receipt of your comments to our initial
filing on Form SB-2 dated April 19, 2006. We thank you for your input and this
letter is intended to respond accordingly. Each paragraph number of this letter
corresponds to your comments to us dated April 19, 2006, and we have attached
two redlined copies and one clean copy, each such copy bound, of our amended
registration statement on Form SB-2 for your timely review and comment as
appropriate. We note to you that in addition to the comment you have made, we
have amended our filing to include another quarter of financial information to
keep this filing current.
Results of Operations - Revenues, page 10
- -----------------------------------------
1. COMMENT. We note your revisions in response to our prior comment 2 of
our letter dated April 10, 2006, specifically, that you generated
$1,350 of revenue from the treatment of one patient using T-cell
therapy. In this regard, you disclose that T-cell therapy is available
to patients on an "experimental basis." Please provide a materially
complete explanation of how it is that you are able to provide T-cell
treatment on an "experimental basis" and charge patients for these
services without approval from the US Food and Drug Administration.
Also, is the FDA aware that you have charged fees for providing this
service in the past? Finally, reconcile your disclosure with that
contained on page 13 where you indicate that you do no commercialize
or market T-cell therapy. We may have further comment after reviewing
your response.
RESPONSE: Cancer Therapeutics is able to provide experimental T-cell
therapy for patients through patient-funded research. Patients,
through their physicians, request to have cells from their tumors
grown. If the patient's own T-cells can be grown in a culture, then
these T-cells can be used by the patient's physician for treatment
using an FDA approved support drug called interleukin-2. Cancer
Therapeutics' role is to attempt to grow the T-cells for patients and
physicians, and not to do the actual injection of the patient's cells.
Each year the FDA reviews each of Cancer Therapeutics' INDs and any
applications of the INDs. In 2004, the FDA visited Cancer
Therapeutics. The FDA has been satisfied each year with the use of the
INDs and is aware of Cancer Therapeutics' use of patient-funded
research. The costs passed through to the patients are for the costs
and expenses for growing the T-cells.
Cancer Therapeutics does not market or commercialize the T-cell
therapy. This is an accurate statement. Physicians that store tumors
in the Cryobank are aware that Cancer Therapeutics has an IND allowing
for the harvest of T-cells. At the physician's and patient's request,
we can attempt to grow T-cells. Many scholarly papers have been
written on the possible benefits of T-cell injection and oncologists
are aware of T-cell therapy. The T-cell patient-funded research
partially covers the costs that are associated with the experimental
T-cell therapy. Patient funded research supports research efforts, but
does not purchase a product. Sometimes, the research is unsuccessful
in producing any T-cells. The FDA has not raised any concern over
Cancer Therapeutic's use of patient-funded research. In fact, I have
attached one of the many ethics studies regarding patient-funded
research.
In sum, Cancer Therapeutics uses patient-funded research, does not
market or commercialize their services and is in full compliance with
the FDA in its use of its INDs.
We hope that our responses to your comments have been both timely and
succinct. If you require any further information, please contact me at the
number above via telephone or fax, or by e-mail at kdenos@denoslaw.com.
KENNETH I. DENOS P.C.
/s/Kenneth I. Denos
--------------------------
Kenneth I. Denos
cc: Robert Oldham, M.D.
Michael Low
Chene Gardner