On September 7, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that it has reached its enrollment target of 132 patients for the company’s global Phase 2b clinical trial of aldoxorubicin in patients with previously treated small cell lung cancer (SCLC) (Press release, CytRx, SEP 7, 2016, View Source [SID:1234514980]). The Phase 2b study is a randomized, comparative trial being conducted at 41 sites in the United States, Hungary and Spain. Schedule your 30 min Free 1stOncology Demo! "Patients with metastatic small cell lung cancer who have relapsed or are refractory to first-line chemotherapy have few treatment options," said Steven A. Kriegsman, Chairman and CEO of CytRx. "Aldoxorubicin represents a potential new therapy to combat this aggressive form of cancer. The Phase 2b trial uses a lower dose of aldoxorubicin than our Phase 3 trial in soft tissue sarcoma, which may improve the tolerability and potentially allow patients to stay on treatment longer. We look forward to reporting the trial results once they are available."
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Because of the unmet medical need for patients with second-line SCLC, if the global Phase 2b clinical trial results are positive, CytRx intends to meet with the U.S. FDA to discuss the regulatory pathway for the submission of a New Drug Application for aldoxorubicin in this patient population.
Trial Design
The multicenter, randomized, open-label, global Phase 2b clinical trial enrolled 132 patients with metastatic SCLC who either did not respond to, or who progressed following treatment with one systemic therapy. Trial patients were randomized 1:1 to be treated with aldoxorubicin at a dose of 230mg/m2 (170mg/m2 of doxorubicin equivalents) or standard dose topotecan. The primary endpoint of the study is progression-free survival, and secondary endpoints include overall survival, response rates and safety.
About Small Cell Lung Cancer
An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year. In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use. The five-year survival rate is less than 7%, in part, because an estimated 70% of patients have extensive disease at diagnosis. According to the American Cancer Society, more than 33,000 new cases will be diagnosed in the USA in 2016. GlobalData estimates the 2016 incidence of SCLC in Europe and Asia to be greater than 32,000 and 175,000, respectively.
About Aldoxorubicin
Aldoxorubicin is a rationally-engineered cytotoxic which combines doxorubicin, a widely used chemotherapeutic agent, with a novel linker molecule that binds directly and specifically to circulating albumin, the most abundant protein in the bloodstream. Protein-hungry tumors concentrate albumin, which facilitates the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. Typically, doxorubicin is delivered systemically and is highly toxic, which limits dosing to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Using this acid-sensitive linker technology, aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4 times). To date, there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2. Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized, global Phase 2b clinical trial in first-line STS.