Re: Ovarian cancer - Treatment stopped (suggestions made)

J wrote:

From a support forum

J
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Subject: Ovarex clinical trial stopping
Date: 01/03/2008

Today I received a call from the clinical trial nurse at my oncologist
office. She called to inform me that my Ovarex clinical drug trial was
stopping. The manufacturer has determined that the drug was ineffectual
and was stopping the trial. I have been on this drug trial since March
2005 and learned today that I was actually receiving the drug. (It was a
double blind study). This has been devastating news since I really believe
it has helped to keep me in remission from my stage 3 ovarian cancer. Has
anyone else received this news that is on the Ovarex study?

http://www.biospace.com/news_story.aspx?NewsEntityId=79446

United Therapeutics Corporation (UTHR) Release: Clinical Studies of OvaRex in Advanced Ovarian
Cancer Fail to Meet Primary Endpoint
12/5/2007

SILVER SPRING, Md. and WELLESLEY HILLS, Mass., Dec. 5 /PRNewswire- FirstCall/ -- United
Therapeutics Corporation (Nasdaq: UTHR - News) and its wholly- owned subsidiary, Unither
Pharmaceuticals, Inc., announced today the completion of their two pivotal trials of OvaRex®
MAb for the treatment of advanced ovarian cancer. Preliminary analysis demonstrates that the
studies failed to reach statistical significance.

The identical studies, known as IMPACT I and II (IMunotherapy Pivotal ovArian Cancer Trial),
were randomized, double-blind, placebo-controlled trials conducted at over 60 centers across
the United States. The studies enrolled 367 ovarian cancer patients and assessed the efficacy
of OvaRex mono- immunotherapy during the so-called "watchful waiting" period following front-
line carboplatin-paclitaxel based chemotherapy. The program sought to confirm data observed in
a subset analysis of a prior randomized phase II study, which suggested the potential of OvaRex
to extend the time to disease relapse among patients who had successfully completed front-line
therapy. The studies were well balanced in terms of patient demographics and the safety profile
was similar between active and control populations. The studies demonstrated no difference
between active (standard of care followed by OvaRex) and control (standard of care followed by
placebo) populations. The results of IMPACT I and II were consistent with each other. There
were no statistically significant differences in safety profiles and the quality of life
between the active and control groups.

Further review and analysis of the IMPACT I and II preliminary results is ongoing and full data
from the IMPACT trials is expected to be presented at an upcoming medical meeting and published
in a peer-reviewed journal.

OvaRex MAb-B43.13 (oregovomab) is one of five investigational immunotherapeutic monoclonal
antibodies which Unither Pharmaceuticals licensed in April 2002 from AltaRex Medical Corp., a
wholly-owned subsidiary of ViRexx Medical Corp. Based on the preliminary results from the
IMPACT trials, Unither Pharmaceuticals intends to terminate the license agreement and intends
to cease further development of the entire platform of antibodies. United Therapeutics is
currently determining the amount of exit costs associated with termination of this program.
While a precise estimate of write-down charges is not yet known, United Therapeutics has
approximately $7 million in assets related to this program that are subject to write-down
during the fourth quarter of 2007.

"Given what appeared to be the promising clinical activity observed in a subset of patients
from an earlier phase II trial, we are very surprised by these findings. The IMPACT trials,
which were well designed and rigorously conducted, indicate that the approach of triggering
tumor-specific immunity using a murine monoclonal antibody has its challenges," said
Christopher Nicodemus, MD, Unither Pharmaceuticals' Senior Vice President Clinical Research &
Development.

"We are all disappointed that OvaRex did not make it to the finish line as a new therapeutic
for ovarian cancer, and we owe a huge debt of gratitude to the women and physicians who
participated in the studies," said Peter Gonze, Unither Pharmaceuticals' Chief Operating
Officer.


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