USC Keck School of Medicine's Dr. Alan Epstein Receives Prestigious National Cancer...

USC Keck School of Medicine's Dr. Alan Epstein Receives Prestigious National
Cancer Institute RAID Award for Breakthrough IL-2 Molecule Therapeutic
$3.5 Million Award Will Advance Clinical "Proof of Principle" for Expanded
Clinical Evaluation

LOS ANGELES, July 7 /PRNewswire-USNewswire/ -- The University of Southern
California today announced that Dr. Alan Epstein of the USC Keck School of
Medicine has received approval for a $3.5 million drug development project
through the Rapid Access to Intervention Development (RAID) program of the
National Cancer Institute (NCI) for his breakthrough Interleukin-2 (IL-2)
cytokine immunotherapy analog. This is the second RAID award Dr. Epstein has
received from the National Cancer Institute.

The NCI RAID program is a peer-reviewed competitive award program designed to
assist translation of novel anticancer therapeutics to the clinic. The goal
of the program is to show proof of principle that a new molecule is a viable
candidate for expanded clinical evaluation. As a RAID award recipient, Dr.
Epstein will receive access to drug development resources of the Developmental
Therapeutics Program. These resources will be used to further the preclinical
development of his IL-2 analog therapy for the treatment of certain cancers
that appears to retain the benefits of existing IL-2 therapies without the
major side effects that currently limit their application.

IL-2 cytokine immunotherapy is used to treat metastatic melanoma and
metastatic renal cell carcinoma, diseases that afflict over 60,000 and 50,000
people in the United States each year, respectively. An increase in melanoma
incidence has elevated the disease to the sixth most common cancer in the
United States. Approximately 60,000 Americans developed invasive cutaneous
melanoma in 2007, with an estimated additional 48,000 or more cases of
melanoma in situ. The current lifetime risk for developing invasive melanoma
is 1 case per 60 Americans. Currently, IL-2 is the only FDA approved
immunotherapeutic agent.

But while the current therapy provides unparalleled recovery for certain
cancer patients, the application of IL-2 is severely limited by its
significant toxicity and resulting side effects, especially that of capillary
leak syndrome where leakage of fluid from the blood results in dangerously low
blood pressure (hypotension), edema and multiple organ failure. Capillary leak
syndrome affects as many as 65% of patients and can lead to the cessation of
therapy.

Dr. Epstein has developed an IL-2 analog that eliminates the side effect of
capillary leak syndrome while retaining the cytokine and therapeutic activity
of IL-2. His extensive pre-clinical data indicates that this IL-2 analog will
allow more clinically effective doses to be administered, resulting in
significantly improved disease control with fewer complications.

"We believe the full potential of IL-2 has yet to be realized because of its
limiting toxicity. This discovery could mean an exponentially improved success
rate for cancer therapies," said Alan Epstein. "I am thrilled NCI saw the
priority value of this therapeutic and awarded RAID assistance to help propel
the manufacturing of this novel molecule toward Phase 1 clinical trials."

"We are in the midst of a biomedical revolution. New technologies promise to
reshape medicine - with novel applications in new therapies, drug delivery,
and patient care," said Dr. Richard Hull, Senior Director of Innovation
Advancement and Business Development for the USC Stevens Institute for
Innovation. "The work and success of Dr. Epstein is a great example of how USC
is focused on translating top-notch laboratory research into breakthrough
clinical applications that save lives and improve healthcare."

Pivotal BioSciences, Inc., a privately-held Los Angeles-based biotechnology
company developing innovative low toxicity therapies for cancer, has licensed
the molecule from USC. The technology is covered under U.S. Patent #7371371
issued on May 13, 2008 titled, "Interleukin-2 Mutants with Reduced Toxicity."

Dimitri Villard, CEO of Pivotal BioSciences, Inc., added, "We are delighted
that the National Cancer Institute's RAID Program will undertake the critical
next steps of process development, manufacturing and toxicology studies that
will enable us to apply to the FDA for a Phase I clinical trial. This
fortuitous award enables us to bridge the funding gap that so many
pre-clinical stage biotechnology companies have experienced lately; we are
looking forward to working with Dr. Epstein and USC Stevens to see this
important project through to fruition."

About the Keck School of Medicine of USC
The Keck School of Medicine of the University of Southern California trains
tomorrow's leaders in patient care and biomedical research and provides
advanced health care to the people of Southern California. Increasingly, the
Keck School of Medicine of USC is expanding its biomedical research enterprise
and, in so doing, raising its profile as a premier medical school. At present,
the Keck School of Medicine of USC ranks among the nation's top 25 percent of
medical schools in federally sponsored research (Association of American
Medical Colleges, 2003). Research programs in genetics, cancer, neurogenetics,
transplantation medicine, and other key areas have attracted national
recognition. The School's dual commitments to collaborative interdisciplinary
research and rapidly translating scientific findings from the lab bench to the
patient's bedside have proved pivotal in its continuing success in research.

About the USC Stevens Institute for Innovation
The USC Stevens Institute for Innovation (http://stevens.usc.edu) is a
university-wide institute in the office of the Provost designed to harness the
creative thinking and innovative work at all of USC's 17 professional schools,
the USC College, and research centers across campus to build a
multidisciplinary approach to innovation. To empower USC innovators to make
maximum societal impact with their ideas, the USC Stevens Institute
identifies, nurtures, protects, and transfers to the market the most exciting
innovations from USC, and in turn, provides a central connection for industry
seeking cutting edge innovations in which to invest. Furthermore, the USC
Stevens Institute develops the innovator as well as innovations, through
educational programs, community-building events, and showcase opportunities.

About Pivotal BioSciences, Inc.
Pivotal BioSciences, Inc. is an angel-backed spin-out of the University of
Southern California Keck School of Medicine that has been developing several
promising discoveries in the field of oncology licensed from USC. For more
information, visit www.pivotalbiosciences.com.

Media Inquiries:
Elisa Wiefel Schreiber Leslie Ridgeway
USC Stevens Institute for Innovation Keck School of Medicine of USC
University of Southern California 323-442-2823
p: 213-821-6063 f: 213-821-5001 213-200-8015
wiefel@usc.edu leslie.ridgeway@usc.edu

Dimitri Villard
Pivotal BioSciences, Inc.
310-289-7111
villard@pivotalbiosciences.com

SOURCE University of Southern California

Elisa Wiefel Schreiber of the USC Stevens Institute for Innovation, University
of Southern California, p: +1-213-821-6063, f: +1-213-821-5001,
wiefel@usc.edu; Leslie Ridgeway of Keck School of Medicine of USC,
+1-323-442-2823, +1-213-200-8015, leslie.ridgeway@usc.edu; or Dimitri Villard
of Pivotal BioSciences, Inc., +1-310-289-7111, villard@pivotalbiosciences.com