Panacea announces selection of PAN-622 - a fully human sequence monoclonal antibody against HAAH - as its lead cancer therapeutic product.

Panacea Pharmaceuticals, Inc. (Gaithersburg, MD) announced the selection of PAN-622 -- a fully human sequence monoclonal antibody against HAAH -- as its lead cancer therapeutic product. Developed in collaboration with the Massachusetts Institute of Technology, PAN-622 has demonstrated high affinity and excellent efficacy in animal models of cancer. Having a fully human sequence, PAN-622 is anticipated to have significantly fewer adverse effects compared to chimeric or humanized monoclonal antibodies. Initial human clinical trials with PAN-622 are anticipated to begin in early 2009.

Human Aspartyl (Asparaginyl) Beta-Hydroxylase (HAAH) is an enzyme that modulates signaling factors such as Notch, and is over-expressed in malignant cells. HAAH is present specifically on the cancer cell surface and on the infiltrating edge of tumors; surface expression of HAAH also makes it accessible to drugs or antibodies that are not capable of crossing cellular membranes. Alterations in cellular function due to its overexpression and translocalization are consistent with the cancer phenotype, and include increased cellular proliferation, motility and invasiveness. When HAAH expression is silenced in cancer cells or its enzymatic activity is neutralized on the cell surface, the cancer cells revert to a normal phenotype. HAAH overexpression and its surface expression has been detected in more than 20 different cancer types and in >99% of all tumor samples tested to date (n > 1000). HAAH is not present in significant amounts in adjacent non- transformed tissue as well as normal tissue (n > 500). Therapeutics directed against HAAH, particularly monoclonal antibodies, are likely to be effective in treating a broad range of cancers with minimal adverse effects.

In vitro, Panacea has shown that monoclonal antibodies against HAAH inhibit cell growth in a dose-dependent fashion, inhibit cell motility more than 6-fold and reduce invasion from 26% to 0.1%. Similarly, in a xenograft model of human liver cancer, anti-HAAH antibodies inhibited tumor growth in all animals, with 40% showing no visible tumor. In an animal model of metastatic human colon cancer, treatment with anti-HAAH antibodies inhibits metastasis. To date, PAN-622 has demonstrated the best performance in xenograft models of human liver cancer as measured by inhibition of tumor growth, and thus has been selected as Panacea's lead anti-cancer drug candidate. In recent experiments, nude mice were injected subcutaneously with a human liver cancer cell line and tumors were allowed to grow for 3 days prior to the initiation of treatment. Animals were treated three times per week with PAN-622 or a non-relevant human IgG for four weeks. Mice were observed for a three weeks after the cessation of treatment. PAN-622 inhibited tumor growth in all animals by about 90%, with 40% showing no visible tumor. Tumors did not re-grow in these animals in the period after treatment cessation.

"PAN-622 has demonstrated excellent inhibition of tumor growth in animal models of cancer, and as a cancer-specific therapeutic, should have a low toxicity and adverse effect profile," commented Hossein Ghanbari, Ph.D, Founder, Chairman, CEO and CSO at Panacea Pharmaceuticals. "We are confident that the performance of PAN-622 in animals will be replicated in humans, and quite excited about the potential for this product to effectively treat a broad range of cancers."

HAAH was discovered by researchers at Brown University (Providence, RI) and the Rhode Island Hospital. Panacea holds worldwide exclusive rights to develop and commercialize therapeutic and diagnostic products based on HAAH, and as such owns the rights to PAN-622. PAN-622 is manufactured in high yield under cGMP guidelines, and should enter Phase 1 clinical trials in early 2009 with an initial indication for the treatment of hepatocellular carcinoma.

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.

Panacea 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.

Panacea Pharmaceuticals, Inc.

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