Clovis reports positive results for cancer drug

BOULDER – Biopharma Clovis Oncology Inc. is reporting positive findings midway through a study of a lung-cancer treatment.

Boulder-based Clovis (Nasdaq: CLVS) reported Thursday from a conference in Geneva, Switzerland, that its orally delivered drug, CO-1686, is providing benefits to patients suffering from lung cancer and is being well-tolerated as doses are increased.

One of 62 patients treated at therapeutic doses of CO-1686 discontinued the trial because of adverse events. The most common adverse events were hyperglycemia, nausea, diarrhea, decreased appetite and vomiting.

“CO-1686 provides meaningful and long-term benefit for patients who until now have had limited, if any, options,´ said Jean-Charles Soria, the European lead investigator for the study of CO-1686. “I am very enthusiastic about participating in the continued development of this agent.” Soria is a professor of Medicine and Medical Oncology at Paris University XI and cancer specialist at the Gustave Roussy Institute.

Patrick J. Mahaffy, president and chief executive of Clovis, said, “One of the issues with oncogene-targeted therapies is that while initial response rates can be promising, these responses can be short-lived. In contrast, as CO-1686 Phase 1 data extend and mature, we see both a consistency of response rate that is very encouraging as well as an impressive initial duration of clinical benefit.” Oncogene is a gene that normally directs cell growth. If altered, an oncogene can promote or allow the uncontrolled growth of cancer. Alterations can be inherited or caused by an environmental exposure to carcinogens.

Mahaffy said patients in general benefit from, and stay on, CO-1686 for a prolonged period of time.

“We are pleased that we can deliver this long-term benefit with very good tolerability. … We are increasingly optimistic about the potential of CO-1686 not only to deliver impressive response rates, but also meaningful progression-free survival in both first- and second-line patients.”

The Phase 1 dose-escalation portion of the study is being conducted in the United States, France and Australia. Approximately 100 patients have been treated with CO-1686 to date, with results from the first 62 patients being delivered at the conference.

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