(NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today reported financial results for the three and six months ended June 30, 2013, and provided a clinical update.
“This is a pivotal time at CytRx with multiple near-term significant clinical results,” said Steven A. Kriegsman, CytRx President and CEO. “We are making preparations to begin in the coming months two late-stage clinical trials with aldoxorubicin, our improved version of the widely used chemotherapeutic doxorubicin, and expect to report data in the second half of 2013 from our global Phase 2b clinical trial testing aldoxorubicin head-to-head against doxorubicin as a first-line therapy for soft tissue sarcomas.”
“We plan to initiate a Phase 2b clinical trial later this year in patients with advanced, relapsed glioblastoma (brain cancer), following exciting, statistically significant efficacy data that we reported in July showing that aldoxorubicin induced tumor regression and significantly increased the lifespan of animals with intracranial implanted human glioblastoma,” said Mr. Kriegsman. “Our decision to rapidly move into the clinic was prompted by aldoxorubicin’s demonstrated ability to cross the blood-brain barrier and concentrate at the site of glioblastoma tumors. Effective treatment of glioblastoma is a major unmet medical need, and there is no therapy that prolongs life for this difficult-to-treat, deadly cancer after it relapses.
“Our global pivotal Phase 3 trial is expected to commence in the first quarter of 2014. This clinical trial will evaluate aldoxorubicin as a treatment for patients with soft tissue sarcomas which have progressed following prior treatment with chemotherapy. The Phase 3 pivotal trial is being conducted under a special protocol assessment (SPA) with progression free survival as the primary endpoint,” he added.
Recent Clinical Highlights
- In May - announced initial data from a Phase 1b clinical trial demonstrating that aldoxorubucin has distribution half-life of 20-24 hours following infusion, which is significantly longer than the five minute half-life of doxorubicin. The trial also indicated that aldoxorubicin’s distribution to healthy tissue was 250-fold less than that of doxorubicin. Aldoxorubicin showed prolonged clinical activity in two patients with small-cell lung cancer who had failed other therapies.
- In June - presented preliminary results from a Phase 1b clinical trial that showed that aldoxorubicin administered at 90% of its single agent dose could safely be delivered in combination with doxorubicin at 50% of its single agent dose to patients with advanced solid tumors. The presentation was made at the American Society of Clinical Oncology (ASCO) conference.
- In June - announced the completion of enrollment of 105 evaluable patients in the global Phase 2b clinical trial with aldoxorubicin as a first-line treatment for soft tissue sarcoma. This clinical trial allows for a head-to-head evaluation of efficacy and safety of aldoxorubicin and doxorubicin.
- In July - reported highly favorable data from a confirmatory preclinical trial of human glioblastoma that showed statistically significant efficacy of arimoclomol (prolonged survival) and highly specific uptake of drug in the tumor only and not normal brain tissue.
Second Quarter 2013 Financial Results
- 2H13 – initiation of Phase 2b clinical trial with aldoxorubicin in patients with relapsed glioblastoma.
- 2H13 – progression free survival and tumor response results from the global Phase 2b clinical trial directly comparing the efficacy and safety of aldoxorubicin and doxorubicin as a first-line treatment for patients with soft tissue sarcoma.
- 1Q14 – initiation of global Phase 3 pivotal clinical trial with aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma who have failed chemotherapy.
- Ongoing work in expanding the oncology pipeline by combining the novel linker platform technology with additional chemotherapeutic agents.
Net loss for the three months ended June 30, 2013 was $3.4 million, or $0.11 per share, compared with a net loss of $13.3 million, or $0.63 per share, for the three months ended June 30, 2012. In the second quarter of 2013, the Company recognized a non-cash gain of $2.9 million on warrant derivative liability, compared with a loss on warrant derivative liability of $8.5 million for the second quarter of 2012. The Company reported license revenue of $200,000 for the second quarter of 2013 and did not recognize revenue for the second of 2012.