Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination...

Agennix Receives Fast Track Designation From FDA for Talactoferrin in
Combination With Sunitinib for Renal Cell Carcinoma

HOUSTON, May 19 /PRNewswire/ -- Agennix announced today that talactoferrin
alfa (talactoferrin) has been granted Fast Track designation by the U.S. Food
and Drug Administration (FDA) for the first-line treatment of renal cell
carcinoma (RCC) in combination with sunitinib (Sutent(R) - Pfizer).

The Fast Track program is designed to expedite the review of investigational
drugs for the treatment of patients with serious or life-threatening diseases
where there is an unmet medical need. Fast Track designations allow a company
to file a New Drug Application (NDA) or Biologics License Application (BLA) on
a rolling basis and permit the FDA to review the filing as it is received,
rather than waiting for the complete submission prior to commencing the review
process. Additionally, NDAs and BLAs for fast track development programs are
eligible for priority review which may result in an abbreviated review time of
six months.

Additional Clinical Updates

Agennix also announced that two pivotal Phase III trials in patients with
locally advanced or metastatic non-small cell lung cancer (NSCLC) are underway
at a number of leading U.S. clinical sites. FORTIS-M is a randomized,
placebo-controlled, 720-patient trial of talactoferrin monotherapy in patients
with Stage IIIB/IV NSCLC. Patients who have failed two or more prior systemic
anti-cancer therapies will be randomly assigned (2:1) to receive either oral
talactoferrin or placebo in additional to standard supportive care. The trial
is designed to detect an improvement in overall survival in patients receiving
talactoferrin, and results are expected in 2011.

FORTIS-C is a randomized, placebo-controlled trial evaluating 1100 chemo-naive
NSCLC patients. Newly diagnosed patients with Stage IIIB/IV NSCLC will be
randomly assigned (1:1) to receive standard first-line chemotherapy with
carboplatin and paclitaxel plus either oral talactoferrin or placebo. Agennix
has received Fast Track designation from the FDA for both NSCLC indications as
well as favorable Scientific Advice from the EMEA. Agennix has also received
approval of a Special Protocol Assessment from the FDA for the FORTIS-C trial.
The designs of these two Phase III trials are based on previous successful
randomized, placebo-controlled, Phase II trials which both met their primary
endpoint with supporting results on the secondary endpoints.

"We are pleased with the continued development progress with talactoferrin
including our most recent Fast Track designation and the initiation of our
Phase III NSCLC trials," said Rick Barsky, Chief Executive Officer, Agennix
Incorporated. "This progress, along with the recent success and renewed
interest in immunotherapies, will help us reach our goal of making
talactoferrin available to patients for the treatment of these devastating
diseases."

About Talactoferrin

Talactoferrin is a novel targeted dendritic cell recruiter and activator
(DCRA) being studied for the treatment of several life-threatening diseases
including RCC and NSCLC. Talactoferrin mediates its anti-cancer activity by
targeting dendritic cells which play an important role in activating innate
and adaptive immunity. After being transported into the gut associated
lymphoid tissue (GALT), the largest immune organ in the body, orally
administered talactoferrin induces the recruitment of immature dendritic cells
to the GALT and promotes their maturation. This unique aspect of its function
results in recruitment of dendritic cells that have captured tumor antigens
while in the peripheral circulation. Following maturation, these dendritic
cells activate Natural Killer (NK) and Natural Killer T-cells (NK-T) of the
innate immune pathway and CD8+ lymphocytes of the adaptive immune pathway.
Initiating the immune response in the GALT, and away from the tumor, reduces
the effect of anti-immune factors produced by the tumor.

Talactoferrin Fast Track Designations

Agennix has received Fast Track designation for talactoferrin for the
first-line treatment of RCC in combination with sunitinib. Agennix's RCC
submission included the results from a Phase I trial, and a multi-center,
single arm Phase II trial of talactoferrin in 44 patients with clear cell RCC
who had failed standard therapy. Patients receiving oral talactoferrin in
this Phase II trial had a median progression-free survival of 6.4 months,
median overall survival of 21.1 months, and a one-year survival rate of 77%.
Talactoferrin appeared to be well tolerated, which was consistent with other
talactoferrin studies. The results from the Phase II trial were published in
Cancer in 2008.

Talactoferrin was previously awarded Fast Track designations in NSCLC both for
first line treatment and for patients who have failed two or more prior
systemic anti-cancer therapies. These NSCLC Fast Track designations were
based upon the clinical activity and tolerability data from two randomized
placebo-controlled Phase II trials. Both Phase II trials met their primary
endpoint with supporting results on the secondary endpoints.

About Renal Cell Carcinoma (RCC)

RCC is the most common type of kidney cancer, accounting for approximately 90
percent of kidney tumors. According to the American Cancer Society, there are
approximately 49,000 new cases of kidney cancer diagnosed each year in the
United States. Kidney cancer is uncommon under age 45, and its incidence is
highest between the ages of 55 and 84. For non-metastatic RCC, the current
standard of care is surgical removal of the kidney (nephrectomy), followed by
observation. If the cancer spreads beyond the kidneys, treatment may include
chemotherapy, cytokine therapy, targeted therapy, and/or radiation.
Currently, sunitinib is the most prescribed targeted therapy for first-line
treatment of RCC.

About Agennix

Agennix is a private biopharmaceutical company developing a first-in-class
molecule with immunological activity for the treatment of cancer and other
unmet medical needs. Agennix's lead molecule, talactoferrin, is an
immunomodulatory protein with a novel mechanism of action. The Company is
developing an oral liquid formulation of talactoferrin for cancer indications
and a topical gel formulation for the treatment of diabetic foot ulcers.
Agennix has more than 90 issued patents and more than 50 pending patents
broadly protecting talactoferrin. Agennix has recently initiated Phase III
trials in two non-small cell lung cancer indications (talactoferrin
monotherapy in patients who have failed two or more previous therapies, and
talactoferrin in combination with chemotherapy in previously untreated
patients), and is planning a Phase IIb trial in patients with renal cell
cancer, and Phase II trials in other cancer indications.

The company has recently agreed to merge its business with GPC Biotech, a
publicly traded biopharmaceutical company focused on developing anti-cancer
drugs. The merger is subject to the approval of the shareholders' meeting of
GPC Biotech and to further closing conditions, and is expected to be completed
by the end of 2009.
More information about Agennix is available on the Company's web site at
http://www.agennix.com.

Forward Looking Statements

This press release contains forward-looking statements, which express the
current beliefs and expectations of the management of Agennix. Such
statements are based on current expectations and are subject to risks and
uncertainties, many of which are beyond our control, that could cause future
results, performance or achievements to differ significantly from the results,
performance or achievements expressed or implied by such forward-looking
statements. Actual results could differ materially depending on a number of
factors, and we caution investors not to place undue reliance on the
forward-looking statements contained in this press release. There can be no
guarantee that the merger with GPC Biotech will be completed. Forward-looking
statements speak only as of the date on which they are made and Agennix
undertakes no obligation to update these foward-looking statements even if new
information becomes available in the future.

SOURCE Agennix

Rick Barsky, Chief Executive Officer, +1-713-552-1091, rbarsky@agennix.com or
Atul Varadhachary, M.D., Ph.D., President & Chief Operating Officer,
+1-713-552-1091, avaradhachary@agennix.com, both of Agennix, Inc.; or Media,
Brad Miles of BMC Communications Group, +1-212-477-9007, ext. 17,
bmiles@bmccommunications.com