solbec ann phase 2 targets, page-2

An interesting point to note about the phase 2 target selection is that Imoxine , the treatment used in conjunction with Coramsine to achieve the spectacular success against mesothelioma in the recent mouse tests, is currently in a phase 2 trial against renal cell carcenoma as a single agent.
Hybridon Initiates Phase 2 Trial of Its Oncology Drug Candidate, IMOxine™ CAMBRIDGE, MA, October 26, 2004 – Hybridon, Inc. (AMEX: HBY) today announced that it had commenced patient enrollment of a Phase 2 trial of IMOxine™ (HYB2055) in renal cell carcinoma. IMOxine is a 2nd-generation immunomodulatory oligonucleotide (IMO™) that functions as an agonist of TLR9, a Toll-like receptor in certain cells of the immune system. “In our Phase 1 trial involving 23 refractory solid tumor cancer patients, preliminary results showed that IMOxine was well tolerated and had stimulatory effects on various immunology parameters across the dose range of 40 to 640 micrograms/kg administered subcutaneously once per week,” said Tim Sullivan, Ph.D., Vice President of Development Programs at Hybridon. “Based on the encouraging Phase 1 results observed to date, we are initiating a Phase 2 trial of IMOxine in patients with renal cell carcinoma. The initial site is now open to patient enrollment at the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center. We are currently at various stages of initiation with approximately 10 additional sites.” “Cancer patients in the Phase 1 trial experienced no dose-limiting toxicity with IMOxine treatment,” said John L. Marshall, M.D., Principal Investigator of the Phase 1 study and Director, Developmental Therapeutics and Associate Professor of Medicine at the Lombardi Comprehensive Cancer Center. “Two of the three renal cell patients had clinically relevant stable
disease in the Phase 1 study, including one patient who continues into the tenth month of IMOxine treatment.” “Patients with metastatic renal cell carcinoma often have compromised clinical status, making it difficult for them to tolerate currently accepted immunotherapy with interleukin-2 and interferon-alpha” said Asim Amin, M.D., Ph.D., Principal Investigator of the Phase 2 study at the Lombardi Comprehensive Cancer Center and Assistant Professor of Medicine at Georgetown University Medical Center.