September 3, 2008 - Gaithersburg, Maryland - Panacea Pharmaceuticals, Inc. today announced the issuance of U.S. Patent Number 7,413,737 covering antibodies against human aspartyl (asparaginyl) beta-hydroxylase (HAAH), a proprietary human cancer biomarker and therapeutic target. These antibodies were developed in collaboration with the Massachusetts Institute of Technology (MIT) and Panacea has exclusive, worldwide rights to this patent for development of human cancer diagnostics and therapeutics. Panacea is developing PAN-622, an all-human sequence anti-HAAH monoclonal antibody covered under this patent, as a cancer therapeutic antibody drug and anticipates the start of Phase 1 clinical trials in early 2009.
HAAH is a cancer molecular marker that has been detected by immunohistochemical staining in a broad range of cancers; this marker was originally discovered at the Rhode Island Hospital / Brown University. Research done both at Panacea and in collaboration with Brown University / Rhode Island Hospital has established HAAH as an excellent drug target for cancer therapy as well as a marker for cancer diagnosis. HAAH over-expression has been observed in more than twenty different cancers, and HAAH has been shown to be highly specific for cancer and absent in adjacent non-affected tissue as well as tissue from cancer-free individuals. In cancer, HAAH is found on the cell surface and in normal cells found in minute quantities inside the cell. As such, HAAH is an excellent therapeutic target. Panacea has demonstrated the efficacy of PAN-622, an all-human sequence anti-HAAH monoclonal antibody, in animal models of cancer. In these experiments PAN-622 inhibited tumor growth in 90 percent of animals, with 40 percent showing no visible tumor. Tumors did not re-grow beyond the period of drug administration. Due to its all human sequence, PAN-622 is anticipated to have low toxicity in humans. And PAN-622 is currently being manufactured under cGMP at high yields. Clinical trials of PAN-622 will be initiated in early 2009, with an initial indication for the treatment of liver cancer. In addition, the presence of HAAH protein in serum has been demonstrated to be highly sensitive and specific for cancer in hundreds of patients with a range of cancer types, and Panacea has developed serum diagnostic tests measuring HAAH for prostate lung, breast and colon cancer.
PAN-622 and other antibodies covered under U.S. Patent Number 7,413,737 were developed in collaboration with MIT using a proprietary yeast display technology. More detailed information is included in Yeung YA, Finney AH, Koyrakh IA, Lebowitz MS, Chanbari HA, Wands JR, Wittrup KD. Isolation and characterization of human antibodies targeting human aspartyl (asparaginyl) beta-hydroxylase. Hum Antibodies, 16(3-4):163-176, 2007.
"We are excited about receiving notice of the issuance of the patent covering antibodies against HAAH, and particularly PAN-622, our all-human sequence monoclonal antibody against HAAH," noted Hossein Ghanbari, Ph.D., Chairman, CEO and CSO at Panacea Pharmaceuticals. "We are quickly advancing PAN-622 toward clinical trials and we are confident that this monoclonal antibody will prove to have tremendous potential as a cancer therapeutic agent."
"HAAH is an excellent target for monoclonal antibody cancer therapeutics, and we have developed several high affinity antibodies against HAAH with good promise as cancer therapeutics", commented K. Dane Wittrup, Ph.D., Carbon P. Dubbs Professor of Chemical Engineering & Bioengineering at the Massachusetts Institute of Technology. "PAN-622 as an all-human sequence monoclonal antibody is particularly exciting, and its efficacy in preclinical mouse models of cancer is quite encouraging."
In addition to PAN-622, Panacea is developing an antibody-toxin conjugate utilizing PAN-622. Panacea has demonstrated that anti-HAAH antibodies are internalized upon binding to the cell surface of cancer cells. In addition, cytotoxicity as measured by a cell proliferation assay has been demonstrated following internalization of a PAN-622-toxin conjugate. This fact, coupled with the exclusivity of the surface expression of HAAH to cancer cells, suggests the potential clinical utility of PAN-622 for the specific delivery of cytotoxic agents to cancer cells.
About Panacea Pharmaceuticals, Inc.
Panacea Pharmaceuticals, Inc. is a privately-held biopharmaceutical company focused on the development and commercialization of therapeutics and diagnostics for diseases with substantial, unmet clinical needs. The Company's product development strategy is based on novel therapeutic agents and approaches for cancer treatment, as well as acute and chronic neurodegenerative conditions, such as hypoxia-induced neurological insult, Parkinson's Disease, and Alzheimer's Disease. Panacea has an extensive patent portfolio covering its neurodegenerative and oncology technologies. Panacea Laboratories is a division of Panacea Pharmaceuticals, Inc.
About Panacea's Oncology Platform
In addition to the cancer therapeutic PAN-622, Panacea offers: PC Detect®, a diagnostic test used in conjunction with PSA and digital rectal exam to identify patients with prostate cancer; LC Detect® , a diagnostic test to aide in the detection of patients with lung cancer; BC Detect®, a diagnostic test to aide in the detection of recurrence of breast cancer; CC Detect®, a diagnostic test to aide in the detection of colo-rectal cancer; and TK Sense®, which determines whether white blood cells from patients with chronic myelogenous leukemia (CML) are sensitive or resistant to imatinib, the therapy of first choice for CML patients, prior to initiation of therapy. Each of these tests is offered as a laboratory service performed by Panacea Laboratories (www.panacea-labs.com), a division of Panacea Pharmaceuticals, Inc.
Additional information about the Company is available at www.PanaceaPharma.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.
Stephen N. Keith, MD, MSPH
President & Chief Operating Officer
Phone 240-243-8000; FAX 240-4650