ironjustice

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/06-
09-2004/0002190150&EDATE=

VAMC and Agennix Release Lactoferrin Cancer Trial Results at ASCO

HOUSTON, June 9 /PRNewswire/ -- The Department of Hematology/Oncology at
the Veterans Affairs Medical Center (VAMC), Houston and Agennix Inc.,
disclosed results from two Phase I/II cancer trials with oral recombinant
human lactoferrin (rhLF). The trials are taking place in the United States
and in South America. Teresa G. Hayes, M.D., Ph.D., Principal Investigator at
the VAMC, is conducting the U.S. trial. The South American trial is being
conducted at six centers in Argentina, Brazil and Chile. The data was
published at the 40th Annual Meeting of the American Society of Clinical
Oncology (ASCO) in New Orleans.
Patients with advanced or metastatic cancers that had failed standard
chemotherapies were dosed with oral rhLF administered as a single agent. RhLF
appeared to be safe and well tolerated without a single drug related SAE.
Among the 45 evaluable patients with a variety of tumor types, rhLF showed a
69% reduction in the average tumor growth rate (p<0.001). The effect in the
major tumor types was even more dramatic - 89% and 105% reductions (both
p<0.05) in average tumor growth rates in non-small cell lung cancer (NSCLC)
and renal cell cancer (RCC), respectively.
In the nine NSCLC patients, there was an apparent survival benefit. The
median survival already substantially exceeds the published median survival in
this patient population, and the 12-month survival rate of 57% with rhLF is
far higher than the 19% rate expected from the literature (p<0.05). Among the
six RCC patients, there was one (17%) confirmed durable partial response
(currently 53% tumor shrinkage by RECIST compared to tumor size at the start
of rhLF therapy 10 months ago). The other five RCC patients all showed
shrinkage or a reduction in the rate of growth of their target lesions. The
median PFS in the RCC patients of 6.1 months compares favorably to the
expected rate from the literature of 2.5 months, and the 4-month PFS of 83% is
much higher than the expected rate of 20% (p<0.01). Results in both NSCLC and
RCC, though with small numbers of patients, also compare favorably with the
published literature on approved drugs. Larger Phase II trials are underway
in both NSCLC and RCC.
Rick Barsky, CEO of Agennix, said, "We are pleased with the results of
these initial trials. An orally administered, non-toxic, safe and well
tolerated drug that is effective against a wide range of common cancers would
be tremendously exciting to patients and physicians."

About VAMC: The Houston Veterans Administration Medical Center is the
largest facility in the nationwide VA system. Patients from a large catchment
area, including Texas, Louisiana and Mississippi, come to the Houston VA for
cancer treatment. The modern facility, certified as a Cancer Center by the
American College of Surgeons, is staffed with Board-Certified Hematologists
and Oncologists. All modalities of cancer care are available at the VAMC,
including chemotherapy, radiation therapy, and surgery.

About Agennix: Agennix, a privately owned Houston-based biopharmaceutical
company, is the world leader in the development of recombinant human
lactoferrin (rhLF), a natural immunomodulatory protein. Oral rhLF has been
shown to be safe and well tolerated. It has also been shown to be effective in
cancer, asthma and wound healing pre-clinical models, and in Phase I/II human
clinical trials in cancer. Agennix is the first and only company to
manufacture substantial quantities of human lactoferrin and holds global
patents on its technology, with 73 issued patents, and more than 50 pending
patents. Agennix has six Phase II human clinical trials currently underway in
the treatment of cancer, asthma, and diabetic foot ulcers.
More information about Agennix is available on the Company's web site at
http://www.agennix.com.

SOURCE Agennix Inc.
Web Site: http://www.agennix.com

Who loves ya.
Tom

Jesus Was A Vegetarian! http://jesuswasavegetarian.7h.com
Man Is A Herbivore! http://pages.ivillage.com/ironjustice/manisaherbivore
DEAD PEOPLE WALKING http://pages.ivillage.com/ironjustice/deadpeoplewalking

ironjustice

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/06-
09-2004/0002190150&EDATE=

VAMC and Agennix Release Lactoferrin Cancer Trial Results at ASCO

HOUSTON, June 9 /PRNewswire/ -- The Department of Hematology/Oncology at
the Veterans Affairs Medical Center (VAMC), Houston and Agennix Inc.,
disclosed results from two Phase I/II cancer trials with oral recombinant
human lactoferrin (rhLF). The trials are taking place in the United States
and in South America. Teresa G. Hayes, M.D., Ph.D., Principal Investigator at
the VAMC, is conducting the U.S. trial. The South American trial is being
conducted at six centers in Argentina, Brazil and Chile. The data was
published at the 40th Annual Meeting of the American Society of Clinical
Oncology (ASCO) in New Orleans.
Patients with advanced or metastatic cancers that had failed standard
chemotherapies were dosed with oral rhLF administered as a single agent. RhLF
appeared to be safe and well tolerated without a single drug related SAE.
Among the 45 evaluable patients with a variety of tumor types, rhLF showed a
69% reduction in the average tumor growth rate (p<0.001). The effect in the
major tumor types was even more dramatic - 89% and 105% reductions (both
p<0.05) in average tumor growth rates in non-small cell lung cancer (NSCLC)
and renal cell cancer (RCC), respectively.
In the nine NSCLC patients, there was an apparent survival benefit. The
median survival already substantially exceeds the published median survival in
this patient population, and the 12-month survival rate of 57% with rhLF is
far higher than the 19% rate expected from the literature (p<0.05). Among the
six RCC patients, there was one (17%) confirmed durable partial response
(currently 53% tumor shrinkage by RECIST compared to tumor size at the start
of rhLF therapy 10 months ago). The other five RCC patients all showed
shrinkage or a reduction in the rate of growth of their target lesions. The
median PFS in the RCC patients of 6.1 months compares favorably to the
expected rate from the literature of 2.5 months, and the 4-month PFS of 83% is
much higher than the expected rate of 20% (p<0.01). Results in both NSCLC and
RCC, though with small numbers of patients, also compare favorably with the
published literature on approved drugs. Larger Phase II trials are underway
in both NSCLC and RCC.
Rick Barsky, CEO of Agennix, said, "We are pleased with the results of
these initial trials. An orally administered, non-toxic, safe and well
tolerated drug that is effective against a wide range of common cancers would
be tremendously exciting to patients and physicians."

About VAMC: The Houston Veterans Administration Medical Center is the
largest facility in the nationwide VA system. Patients from a large catchment
area, including Texas, Louisiana and Mississippi, come to the Houston VA for
cancer treatment. The modern facility, certified as a Cancer Center by the
American College of Surgeons, is staffed with Board-Certified Hematologists
and Oncologists. All modalities of cancer care are available at the VAMC,
including chemotherapy, radiation therapy, and surgery.

About Agennix: Agennix, a privately owned Houston-based biopharmaceutical
company, is the world leader in the development of recombinant human
lactoferrin (rhLF), a natural immunomodulatory protein. Oral rhLF has been
shown to be safe and well tolerated. It has also been shown to be effective in
cancer, asthma and wound healing pre-clinical models, and in Phase I/II human
clinical trials in cancer. Agennix is the first and only company to
manufacture substantial quantities of human lactoferrin and holds global
patents on its technology, with 73 issued patents, and more than 50 pending
patents. Agennix has six Phase II human clinical trials currently underway in
the treatment of cancer, asthma, and diabetic foot ulcers.
More information about Agennix is available on the Company's web site at
http://www.agennix.com.

SOURCE Agennix Inc.
Web Site: http://www.agennix.com

Who loves ya.
Tom

Jesus Was A Vegetarian! http://jesuswasavegetarian.7h.com
Man Is A Herbivore! http://pages.ivillage.com/ironjustice/manisaherbivore
DEAD PEOPLE WALKING http://pages.ivillage.com/ironjustice/deadpeoplewalking

david s-h

Lemme guess, it's bloodletting, iron reduction etc etc etc.

Quite an interesting collection of ailments you've included.

Rgds

pending

underway in


at

http://pages.ivillage.com/ironjustice/deadpeoplewalking