On Septenber 3, 2015 CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that the Phase 2b clinical trial design of its clinical trial in small-cell lung cancer (SCLC) will be presented in the P3.07 Poster Session on SCLC at the 16th World Conference on Lung Cancer in Denver, Colorado, September 6 – 9, 2015 (Press release, CytRx, SEP 3, 2015, View Source;p=RssLanding&cat=news&id=2085122 [SID:1234507391]). Entitled "Phase 2 Study of Aldoxorubicin versus Topotecan for Relapsed/Refractory Small Cell Lung Cancer" (Poster # 1736), the poster will be available starting at 9:30 AM MDT, on September 9, 2015. Additionally, aldoxorubicin will be discussed in the Novel SCLC Therapies Mini Symposium (MS 16) on September, 8, 2015.
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"We are pleased to present the aldoxorubicin Phase 2b clinical trial design in SCLC at the World Conference on Lung Cancer," said Steven A. Kriegsman, Chairman and Chief Executive Officer. "We believe this will raise awareness of aldoxorubicin’s potential to treat patients with relapsed or refractory SCLC, a devastating disease with a large unmet need. In prior Phase 1 trials, we have seen encouraging evidence of SCLC patients with tumor shrinkage and prolonged stable disease. Our previous data in relapsed or refractory solid tumor patients indicates that the dose of aldoxorubicin being administered to these patients is well tolerated and without any treatment-limiting side effects. Up to 21 cycles (4.8 grams/m2) have been given to one patient with small cell lung cancer with minimal side effects and good anti-tumor activity."
The Phase 2b trial is currently enrolling 132 patients at 37 sites in the USA, Hungary and Spain. Patients with metastatic small cell lung cancer who have either relapsed or were refractory to prior chemotherapy will receive either aldoxorubicin or topotecan in a 1:1 randomization. The primary endpoint for the trial is progression-free survival. Overall survival and safety are secondary endpoints.
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 National Cancer Institute, more than 30,000 new cases were diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.
About Aldoxorubicin
The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose 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. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing 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. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far 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.