ImClone Systems Inc. (NASDAQ: IMCL) has announced that its Phase 1 clinical trial of IMC-A12, itss fully human IgG1 anti-insulin-like growth factor-1 receptor monoclonal antibody plus the mTOR inhibitor temsirolimus, has opened for enrollment in patients with advanced solid malignancies and lymphoma.
This study is being carried out at the M.D. Anderson Cancer Center in Houston, Texas and the Barbara Anne Karmanos Cancer Institute/Wayne State University in Detroit, Michigan. This study is a component of an initial stage of at least 10 Phase 1 and 2 clinical trials of IMC-A12. It is designed to specifically target the human IGF-1R to block a signaling pathway that enhances tumor cell proliferation and survival.
In 2007, ImClone completed enrollment into two Phase 1 studies of IMC-A12 with favorable safety and pharmacokinetic profiles, as well as preliminary evidence of anti-tumor activity as a single agent when administered either weekly or every two weeks.
In addition to this Phase 1 study of IMC-A12 plus temsirolimus, Phase 2 studies of IMC-A12 in patients with advanced prostate, pancreatic, colorectal, liver, and head and neck cancers, as well as a series of Phase 1/2 studies in pediatric malignancies, have begun to enroll patients.
June 25, 2008
Pharmacyclics Inc. (NASDAQ: PCYC) is seeing shares surge today after it said that its Phase 1/2 trial of motexafin gadolinium plus antibody targeted radiation therapy demonstrated a high complete response rate in patients with non-Hodgkin’s lymphoma. The results of the study showed a 46% complete response rate in patients with multiply recurrent non-Hodgkin’s lymphoma who were treated with motexafin gadolinium in combination with Yttrium-90 Ibritumomab Tiuxetan, an approved antibody-targeted radiation therapy.
Patients were treated with a standard dose of Zevalin administered with 2.5 to 5.0 mg/kg of MGd given for six days. Of the 28 evaluable patients in the study, 46% showed a complete response and 11% more showed a partial response. Rituximab refractory patients showed an overall response rate of 86%, with a 64% complete response rate and a median time to progression of 14 months.
Adverse events seen were related to bone marrow suppression, an expected side effect of treatment with Zevalin.
This data was part of a presentation at the International Conference on Malignant Lymphoma. Shares are up some 19% at $1.25 today on more than 5-times volume. Its 520week trading range is $0.55 to $3.28 and its market cap is a mere $32.5 million even after the run. As of last quarter, it had roughly $21 million in liquidity from cash and equivalents.
June 5, 2008