CAMBRIDGE, Mass., Oct. 26 /PRNewswire-FirstCall/ -- Hybridon, Inc. today announced that it had commenced patient enrollment of a Phase 2 trial of IMOxine(TM) (HYB2055) in renal cell carcinoma. IMOxine is a 2nd-generation immunomodulatory oligonucleotide (IMO(TM)) 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.
The Phase 2 trial is a two-stage, multi-center, open label study of IMOxine monotherapy in patients with metastatic or recurrent clear cell renal carcinoma. The primary objective is to determine tumor response by RECIST (Response Evaluation Criteria in Solid Tumors). Secondary objectives are safety, duration of response, time to progression, survival one year after the last IMOxine dose, and effect on Quality of Life. Dose levels of 0.16 and 0.64 mg/kg will be evaluated by weekly subcutaneous injection. The Company plans to recruit a minimum of 46 patients into the first stage of the trial.
Hybridon expects to announce more complete results from its Phase 1 trial of IMOxine in refractory cancer patients by the end of the year.
Hybridon, Inc. is a leader in the discovery and development of novel therapeutics based on synthetic DNA. The Company's focus is to develop therapeutics independently and with partners based on two proprietary technology platforms: i) Synthetic immunomodulatory oligonucleotide (IMOTM) motifs that act to modulate responses of the immune system; and ii) Antisense technology that uses synthetic DNA to block the production of disease-causing proteins at the cellular level.
The Company is conducting clinical trials in oncology patients with HYB2055 (IMOxine(TM)), a 2nd-generation IMO, and with GEM(R)231, a 2nd- generation antisense oligonucleotide targeted to protein kinase A, in combination with irinotecan. Hybridon also is collaborating on development of additional second-generation antisense oligonucleotides for the treatment of cancer and viral infections, and has completed a Phase 1 trial of HYB2055 in healthy volunteers. Hybridon has licensed Amplivax(TM) (an adjuvant application of HYB2055) as an adjuvant for IR103, a potential therapeutic and prophylactic vaccine for HIV infection being developed by The Immune Response Corporation.
This press release contains forward-looking statements concerning Hybridon that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Hybridon's actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in preclinical studies or early clinical trials will be indicative of results obtained in future preclinical studies or clinical trials, or warrant further clinical trials and product development; whether the Company will be able to enter into additional site agreements or recruit patients on a timely basis; whether products based on Hybridon's technology will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if such products receive approval, they will be successfully distributed and marketed; whether the patents and patent applications owned or licensed by Hybridon will protect the Company's technology and prevent others from infringing it; whether Hybridon's cash resources will be sufficient to fund product development; and such other important factors as are set forth under the caption "Risk Factors" in Hybridon's Quarterly Report on Form 10-Q filed on August 6, 2004, which important factors are incorporated herein by reference. Hybridon disclaims any intention or obligation to update any forward-looking statements.
Hybridon, Inc. Euro RSCG Life NRP
617-679-5500, x5526 212-845-4268
Tim Sullivan, Ph.D. Robert Stanislaro (media)
Brian Ritchie (investors)
Georgetown University Medical Center
Lindsey A. Spindle
CONTACT: Tim Sullivan, Ph.D. of Hybridon, Inc., +1-617-679-5500, ext.5526, or firstname.lastname@example.org; or Media, Robert Stanislaro, +1-212-845-4268,or Investors, Brian Ritchie, +1-212-845-4269, both of Euro RSCG Life NRP, bothfor Hybridon, Inc.; or Lindsey A. Spindle of Georgetown University MedicalCenter, +1-202-687-7707, or email@example.com