Preliminary Results from VioQuest Pharmaceuticals' Phase I Trial of Novel Akt Inhibitor VQD-002 in Patients with Advanced Leukemias Demonstrate Promising Clinical Activity
"VQD-002's activity among patients with advanced relapsed or refractory acute myeloid leukemia is encouraging as there is no standard treatment regimen for such patients, who generally have a very poor prognosis," said Farhad Ravandi, M.D., Associate Professor of Medicine, Department of Leukemia at University of Texas M.D. Anderson Cancer Center and a principal investigator for the Phase I trial. "To date, we've seen significant reductions in peripheral blood myeloblasts among some patients with advanced leukemias that were refractory to prior regimens. In addition to other hematological improvements, VQD-002 has been well tolerated. Patient accrual and dose escalation in this trial are ongoing."
The Phase I trial is designed to assess the safety, tolerability and pharmacokinetics of VQD-002 and to establish a recommended Phase II dose for further studies among patients. To date, a total of 28 patients have been enrolled at two clinical sites. Eighteen patients are evaluable for toxicity and response, eight patients are evaluable for toxicity only, and two patients are not evaluable.
A complete treatment cycle is 28 days in duration and consists of VQD-002 administered intravenously on days 1, 8, and 15. Cohorts of 3 patients received escalating doses of VQD-002 at 15, 25, 35, and 45 mg/m2. Enrollment to higher doses is ongoing. Patients had progressive disease despite receiving a median of 3 prior treatment regimens (range 1-4).
Preliminary results from the trial show that patients with relapsed, refractory acute myeloid leukemia (AML) experienced a decrease in peripheral blood myeloblasts, a measure of clinical activity. In particular, four patients treated at the 25 mg/m2 or 35 mg/m2 dose level of VQD-002 experienced up to 50 percent reductions in peripheral blast cells. Additional hematological improvements included two patients achieving major improvements in platelet count lasting 7 and 36 days, respectively, and four patients achieving major improvements in neutrophil count lasting a median of 19 days while on therapy. VQD-002 was well-tolerated at the doses studied.
"We are pleased with these interim results from our Phase I trial of VQD-002 among AML patients," said Michael D. Becker, President and Chief Executive Officer of VioQuest Pharmaceuticals. "We are seeing promising anticancer activity in both preclinical and clinical studies of VQD-002 and making excellent progress in defining a dose and schedule for further clinical development of this novel compound. The distinct mechanism of VQD-002, combined with the encouraging preclinical and clinical data to date, support rapidly moving our drug into mono- and combination-therapy Phase II trials in 2008."
The poster presentation titled "Phase I Study of Triciribine Phosphate Monohydrate, a Specific Inhibitor of Akt Phosphorylation, in Adult Patients with Advanced Hematologic Malignancies" was presented at the ASH meeting during a session titled "Acute Myeloid Leukemias: Therapy, excluding Transplantation I." Related abstract #913 appears in the journal Blood, Volume 110, issue 11, November 16, 2007.
VQD-002 (triciribine phosphate monohydrate, or TCN-P), a tricyclic nucleoside that inhibits the phosphorylation of Akt, has demonstrated anti-tumor activity against a wide spectrum of cancers. Amplification, overexpression, and/or activation of Akt, also named protein kinase B, have been detected in a number of human malignancies, including prostate, breast, ovarian, colorectal, pancreatic, and hematologic cancers. Activation of Akt is associated with cell survival, malignant transformation, tumor invasiveness, and chemo-resistance; whereas inhibition of Akt activity causes cell death. These attributes make Akt an attractive target for cancer therapy.
Acute myeloid leukemia (AML) is a cancer that starts in cells that would normally develop into different types of blood cells. AML starts in the bone marrow, but in most cases moves quickly into the blood. It can sometimes spread to other parts of the body including the lymph nodes, liver, spleen, and central nervous system. According to the American Cancer Society, about 44,000 new cases of leukemia will be diagnosed in the United States during 2007. About 1 out of 3 will be AML, and most AML patients will be adults. About 9,000 deaths from AML will occur in the United States during 2007, and almost all will be in adults. AML is generally a disease of older people and is rare before the age of 40. The average age of a patient with AML is about 67 years.
About VioQuest Pharmaceuticals
VioQuest is a New Jersey-based biotechnology company dedicated to becoming a recognized leader in the successful development of novel therapies that benefit cancer patients by in-licensing and advancing clinical stage drug candidates. VioQuest's oncology portfolio includes VQD-002 (triciribine phosphate monohydrate), a targeted inhibitor of Akt phosphorylation, which is currently being tested in Phase I clinical trials in both solid and hematological malignancies; Lenocta(TM) (sodium stibogluconate), an inhibitor of protein tyrosine phosphatases, which is currently in a Phase IIa trial for solid tumors; and Xyfid(TM) (1% topical uracil), which is expected to enter Phase II development in 2008 for the treatment and prevention of Hand-Foot Syndrome, a common side effect from certain chemotherapy treatments.
This press release contains forward-looking statements that involve risks and uncertainties that could cause VioQuest's actual results and experiences to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These forward-looking statements concern the timing, progress and results of the clinical development, regulatory processes, and potential clinical trial initiations of VioQuest's product candidates. These statements are often, but not always, made through the use of words or phrases such as anticipates, expects, plans, believes, intends, and similar words or phrases. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. These statements are subject to various risks and uncertainties and include VioQuest's need for additional capital to fund its clinical development programs, the possibility that the results of clinical trials will not support VioQuest's claims, the possibility that VioQuest's development efforts relating to its product candidates will not be successful, the inability to obtain regulatory approval of VioQuest's product candidates, VioQuest's reliance on third-party researchers to develop its product candidates, its lack of experience in developing and commercializing pharmaceutical products, and the possibility that its licenses to develop and commercialize its product candidates may be terminated. Additional risks are described in VioQuest's Annual Report on Form 10-KSB for the year ended December 31, 2006. VioQuest assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Posted: December 2007