New Prostate test for those concerned about cancer

New Prostate test for those concerned about cancer

Dr. Weeks Clinic:  This blood test is worth doing BEFORE you get needle biopsy.  Ask your doctor about this test.


Test for Prostate Cancer in the Works

Study Shows New Blood Test More Accurate Than PSA Test

By Charlene Laino
WebMD Health News

Reviewed by Louise Chang, MD

Feb. 14, 2008 (San Francisco) — A new blood test that measures a protein that is elevated in people with prostate cancer could spare thousands of men from unnecessary biopsies and risky treatments, researchers report.

The test, which homes in on a protein called human aspartyl (asparaginyl) beta-hydroxylase, or HAAH, adds to the accuracy of standard PSA testing for prostate cancer, says Stephen Keith, MD. Keith is president and chief operating officer of Panacea Pharmaceuticals Inc., in Gaithersburg, Md., which is developing the test and sponsored the study.

The PSA test measures levels of a protein known as prostate-specific antigen in the blood. High PSA levels may signal cancer.

The problem is that not everyone with a high PSA level has prostate cancer. And not everyone with prostate cancer has a high PSA level. This uncertainty leads to many unnecessary prostate biopsies — and to many unnecessary prostate surgeries or radiation treatments.

“There’s a big movement in the field to increase the accuracy of PSA,” says Eric A. Klein, MD, head of urologic oncology at Cleveland Clinic.

“This is one of a number of promising tests,” Klein tells WebMD. Klein is a spokesman for the American Society of Clinical Oncology (ASCO).

The findings were presented at the Genitourinary Cancers Symposium, which is co-sponsored by ASCO and two other cancer care organizations.

HAAH Adds to PSA Accuracy

The latest research involved 233 men with prostate cancer and 43 healthy men over 50 years old.

Results showed that the HAAH test had an overall sensitivity of 95%, meaning that 5% of prostate cancers were missed.

The specificity was 93%, meaning that the test gave false-positive results to 7% of people who didn’t have the cancer.

In contrast, the sensitivity and specificity of PSA are only about 30% to 40%, Keith says.

Importantly, the HAAH test was accurate regardless of a man’s PSA level, he adds.

The test may prove particularly useful for men with PSA scores between 2 and 4, Keith tells WebMD. Typically, doctors only refer men with PSA scores over 4 for biopsy.

“Men with PSA scores of 2 to 4 wouldn’t normally be sent for a biopsy. If they have elevated HAAH levels, they should be,” he says.

In men with PSA scores of 4 to 10, the addition of HAAH could decrease the number of unnecessary biopsies that show no cancer is present from about 75% to 10%, he says.

Panacea scientists plan to apply for FDA approval of the test, which costs about $125.

Prostate cancer is the second most common cancer among men. It is diagnosed in more than 218,000 men and claims more than 27,000 lives each year.

New Cancer Diagnostic Tests from Japan

Abstract
“The HAAH-based cancer serum test is expected to become a single universal diagnostic test to detect early stage tumor presence regardless of tumor bearing organs,” told Dr. Kazumasa Hikiji, Chief Technology Officer of SRL. “By subsequent diagnostic tests utilizing HAAH and other organ specific tumor markers as well as imaging procedures, medical doctors may be able to diagnose cancers in their curable stage.”

The Company’s HAAH Oncology Program is based on the enzyme human aspartyl (asparaginyl) Beta-hydroxylase (HAAH) HAAH over-expression has been detected in primary tumor tissue of all eighteen tumor types tested to date, including cancers of the pancreas, breast, ovary, liver, colon, prostate, lung, brain, and bile duct. HAAH over- expression has been detected in 99% of tumor specimens (greater than 1000) tested to date and has not been detected in normal or adjacent non-affected tissue.

Recent findings in preclinical studies have indicated that over-expression of HAAH is sufficient to induce cellular transformation, to increase cell motility and invasiveness, and to establish tumor formation in animals. Even partial inhibition of HAAH expression has been shown to have a beneficial effect on tumor cells, causing them to revert to a more normal phenotype as measured by the inhibition of growth, motility, and invasiveness. HAAH is over-expressed on the surface of cancer cells, potentially facilitating detection, drug delivery, and enzyme inhibition.


Full Version
Panacea Pharmaceuticals, Inc. and SRL, Inc. of Tokyo, Japan Announce Agreements to Develop and Commercialize HAAH Based Cancer Diagnostic Tests in Japan
Thursday December 18, 9:23 am ET

GAITHERSBURG, Md., Dec. 18 /PRNewswire/ — Panacea Pharmaceuticals, Inc. announced today that it has signed a License & Service Agreement with SRL, Inc. (http://www.SRL-Group.co.jp) of Tokyo, Japan to develop and commercialize cancer diagnostic tests in Japan. The tests will be based on Panacea’s HAAH Oncology Program, which targets the enzyme human aspartyl (asparaginyl) Beta-hydroxylase or HAAH.

SRL is the largest reference laboratory services organization in Japan, having over 2,500 employees and 4,000 items on their test menu.

“We are delighted to be working with SRL and to begin the commercialization of HAAH-based tests in Japan,” stated Kasra Ghanbari, President of the Company. “SRL’s technical expertise, market share, and dedication to quality service and products provide an ideal partner for the commercialization of HAAH diagnostics in Japan.”

The non-exclusive license in Japan will allow SRL to commercialize HAAH- based tests using immunohistochemistry (IHC), immunocytochemistry (ICC), fluorescent in situ hybridization (FISH), enzyme linked immunosorbent assays (ELISA), and quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).

Panacea has received an up-front payment, will receive milestone payments for the development and Japan Health Authority regulatory approval of a HAAH serum immunoassay, and will receive a royalty payment on all sales. Panacea will also provide technical support and key reagents under the service provision of the agreement.

“The HAAH-based cancer serum test is expected to become a single universal diagnostic test to detect early stage tumor presence regardless of tumor bearing organs,” told Dr. Kazumasa Hikiji, Chief Technology Officer of SRL. “By subsequent diagnostic tests utilizing HAAH and other organ specific tumor markers as well as imaging procedures, medical doctors may be able to diagnose cancers in their curable stage.”

Background on HAAH Oncology Program
The Company’s HAAH Oncology Program is based on the enzyme human aspartyl (asparaginyl) Beta-hydroxylase (HAAH).

HAAH over-expression has been detected in primary tumor tissue of all eighteen tumor types tested to date, including cancers of the pancreas, breast, ovary, liver, colon, prostate, lung, brain, and bile duct. HAAH over- expression has been detected in 99% of tumor specimens (greater than 1000) tested to date and has not been detected in normal or adjacent non-affected tissue.

Recent findings in preclinical studies have indicated that over-expression of HAAH is sufficient to induce cellular transformation, to increase cell motility and invasiveness, and to establish tumor formation in animals. Even partial inhibition of HAAH expression has been shown to have a beneficial effect on tumor cells, causing them to revert to a more normal phenotype as measured by the inhibition of growth, motility, and invasiveness. HAAH is over-expressed on the surface of cancer cells, potentially facilitating detection, drug delivery, and enzyme inhibition.

Panacea signed a Collaboration and License Agreement with MedImmune, Inc. in early 2002 to discover, develop, and commercialize therapeutic agents for the prevention or treatment of human disease based on Panacea’s HAAH technology or its pathways. Panacea has retained all rights to the development of diagnostic products based on HAAH.


About Panacea Pharmaceuticals, Inc.
Panacea Pharmaceuticals, Inc. is an emerging biopharmaceutical company focused on utilizing functional genomics and proteomics to develop therapeutics and diagnostics for diseases with substantial unmet clinical need. The Company’s product development focus is on novel proteins and biochemical pathways related to cellular regulation and cell cycle abnormalities in oncology as well as both acute and chronic neurodegenerative conditions such as hypoxia-induced cognitive impairment, Parkinson’s disease, and Alzheimer’s disease. The Company’s wholly-owned subsidiary, Proteus Diagnostics, Inc., will be developing in vitro diagnostics including pharmacogenomic and pharmacoproteomic tools for cancer detection, diagnosis, prognosis, treatment selection, and follow-up.

More information is available at http://www.PanaceaPharma.com and http://www.ProteusDx.com.

Except for historical information presented in this press release, matters discussed herein may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward- looking statements are based on the opinions and estimates of management only as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance, or achievements expressed or implied by such statements. Factors that might cause such a difference include, but are not limited to, uncertainties related to our access to capital, the progress, costs, and results of any clinical trials undertaken by us, progress of our research and development projects, and uncertainties related to whether our product candidates would ultimately achieve commercial success. We do not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise unless required by law.

Contact:
Panacea Pharmaceuticals, Inc.
Kasra Ghanbari, President
Phone 240-243-8000 x108
FAX 240-465-0450
Kasra@PanaceaPharma.com

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Dr. Weeks Clinic:  This blood test is worth doing BEFORE you get needle biopsy.  Ask your doctor about this test. – Test for Prostate Cancer in the Works – Study Shows New Blood Test More Accurate Than PSA Test By Charlene Laino WebMD Health News Reviewed by Louise Chang, MD Feb. 14, 2008 (San Francisco)…
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