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Aton Pharma, Inc. Announces Promising Phase I Trial Results From SAHA At American Association For Cancer Research/National Cancer Institute/EORTC International Conference; Initiates Clinical Trials Agreement With CTEP

10/19/2005 5:08:53 PM

TARRYTOWN, N.Y., Nov. 20 /PRNewswire/ -- Aton Pharma, Inc., a privately- held biopharmaceutical Company with the mission to discover and develop novel therapeutics for cancer and other diseases, today announced that it had presented results from the oral phase 1 clinical trial on SAHA, its lead product candidate, at the AACR/NCI/EORTC International Conference on "Molecular Targets and Cancer Therapeutics" in Boston, Massachusetts. The Company also announced that it has entered into a Clinical Trials Agreement with the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) to collaborate on the clinical development of SAHA.

Nicholas G. Bacopoulos, Ph.D., President and CEO of Aton said, "Aton is making important contributions to the clinical exploration of histone deacetylase inhibitors in cancer patients. We are excited about the encouraging results from our Phase I trial, as well as the growing interest in SAHA shown by CTEP, the organizers of this important conference, and the oncology community in general. The results reported by our academic collaborators support our continued efforts to bring SAHA to cancer patients as expeditiously as we can."

Aton is conducting its comprehensive phase 1 trial in patients with refractory solid tumors, lymphomas, and leukemias in collaboration with W. Kevin Kelly, D.O., and other leading investigators at Memorial Sloan-Kettering Cancer Center (MSKCC).

The primary objective of the study is to define a safe daily oral dosing regimen for patients with either solid tumors or hematological malignancies. Secondary objectives include evaluation of the pharmacokinetic profile of oral SAHA, determination of the oral bioavailability of SAHA in a fasting and non-fasting state, assessment of the biological effects of SAHA on normal and malignant tissue, and documentation of anti-tumor effects of the treatment.

Study investigators reported a reduction in measurable disease among some patients with solid tumors as well as hematologic malignancies (including one complete remission). Side effects consisted mainly of the constitutional symptoms of diarrhea, anorexia, dehydration and fatigue. However, the effects subsided after the patients stopped taking the drug.

"We continue to be encouraged by the strong evidence of anti-tumor activity in both hematologic malignancy and solid tumor patients. The collaboration with CTEP, in addition to our ongoing phase 2 program, will allow us to further evaluate the safety and efficacy of SAHA," said Carolyn Paradise, M.D., Senior Vice President and CMO.

The agreement with CTEP, also announced today, supports development of SAHA in several clinical trials both as a single agent and in combination with other therapies. CTEP is soliciting for a single-agent pediatric phase 1 study of SAHA and single-agent phase 2 studies. Program priorities for the initial round of phase 2 studies include non-Hodgkin's lymphoma, renal cell carcinoma, bladder cancer, breast cancer, lung cancer, mesothelioma, glioma, and thyroid cancer. CTEP is also soliciting for phase 1 studies of SAHA in combination with 5-fluorouracil (5-FU) and other possible agents which may include anthracycline, platinum, taxane, imatinib mesylate, retinoids, trastuzumab, gemcitabine, hypomethylating agents, radiation therapy, and agents that block the function of Bcl-2. Priority will be given to proposals with correlative studies directed at gaining insight into the molecular mechanisms involved in the induction of apoptosis in tumors by SAHA.

Victoria Richon, Ph.D., co-founder of Aton Pharma, Inc. and Executive Director of Biology, will also give an invited presentation at the AACR/NCI/EORTC International Conference entitled "Development of Histone Deacetylase Inhibitors", as part of a plenary session tomorrow on "Emerging Targets in the Clinic."

About Aton Pharma, Inc.:

Aton Pharma, Inc. is a privately held biopharmaceuticals company that is engaged in the discovery and development of innovative therapeutics, in the emerging field of chromatin science, for cancer and other diseases with an unmet medical need. Two of the company's HDAC inhibitors, SAHA and pyroxamide, are currently in clinical trials in cancer patients. For additional information, please see the company's website at

About CTEP:

The mission of the Cancer Therapy Evaluation Program (CTEP) is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. CTEP accomplishes this mission by funding an extensive national program of cancer research and by sponsoring clinical trials to evaluate new anti-cancer agents, with a particular emphasis on translational research to elucidate molecular targets and mechanisms of drug effects. For additional information, please visit the CTEP website at

Questions regarding the solicitation may be addressed to: James Zwiebel, M.D., Associate Chief, Biologics Evaluation Section Investigational Drug Branch, CTEP, NCI Phone: 301-496-8798 E-mail: CONTACT: Emma Reeve Vice President and Chief Financial Officer 914-347-2900

Aton Pharma, Inc.

CONTACT: Emma Reeve, Vice President and Chief Financial Officer of AtonPharma, Inc., +1-914-347-2900

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