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2004 MAY 5 - (NewsRx.com & NewsRx.net) -- Hybridon, Inc., (HBY) has completed a phase I trial of HYB2055 in healthy volunteer subjects.
In this trial, this drug candidate was safe and biologically active. HYB2055 is a second-generation immunomodulatory oligonucleotide (IMO) that combines a novel DNA structure, referred to as an Immunomer, and a synthetic CpR immunomodulatory motif.
"HYB2055 has exhibited an excellent safety profile over the 32-fold range of dosages evaluated in this phase I trial," said R. Russell Martin, MD, senior vice president of drug development at Hybridon. "Evidence of biological activity by several parameters was seen at all dose levels administered and we have already progressed to higher dosages in a separate, on-going phase I trial in oncology patients."
"Hybridon is developing HYB2055 as IMOxine for oncology applications and Amplivax as a lower dosage product for vaccine adjuvant use," added Stephen R. Seiler, Hybridon's CEO. "Initial results of our phase I cancer trial of IMOxine also have been encouraging. We expect to complete that trial and initiate a phase II trial in cancer patients later this year. The first phase I trial of Amplivax is anticipated to begin in the second quarter of 2004."
Hybridon presented a poster entitled "Immunological Activity of HYB2055, a TLR9 Agonist, in Healthy Volunteers" at the American Association for Cancer Research meeting. An earlier presentation at another meeting had described the safety results of the volunteer trial.
Twenty-eight males aged 18-45 years were ...
Source: HighBeam Research, Phase I healthy volunteer trial of HYB2055 completed.