HemaQuest performed two different trials. In the first placebo-controlled clinical study, 32 healthy volunteers were given single doses of HQK-1001, ranging from two to 20mg/kg. This trial was followed by a second placebo-controlled study, in which 41 healthy volunteers received two weeks of daily doses of HQK-1001 ranging from five to 15mg/kg.
In both studies, there were no clinically significant adverse effects, and the incidence of mild side effects was similar in subjects receiving placebo or HQK-1001. Pharmacokinetic studies showed that single doses at, or above, 10mg/kg reached the targeted plasma drug levels, the company said.
According to the company, subjects treated with HQK-1001 in the multiple dose Phase I clinical trial provided preliminary evidence of its therapeutic potential, as demonstrated by statistically significant increases in young red blood cells, known as reticulocytes.
Ronald Berenson, HemaQuest’s president and CEO, said: These initial clinical studies provide the foundation for subsequent testing of HQK-1001 in patients with hemoglobin disorders, including sickle cell anemia and thalassemia in early 2009. If results of our Phase I clinical trials are confirmed in these upcoming studies, HQK-1001 may also be beneficial for treating other, common types of anemia characterized by reduced production of red blood cells.