LOS ANGELES, Nov. 3, 2015 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today reported financial results for the three months ended September 30, 2015, and also provided an overview of recent accomplishments and upcoming milestones.
“Enrollment in our pivotal global Phase 3 clinical trial of aldoxorubicin in soft tissue sarcoma (STS) continues to progress quite favorably, and is on track to be completed next quarter as planned, with data expected in the second half of 2016,” said Steven A. Kriegsman, Chairman and CEO of CytRx. “The third quarter saw the publication in the prestigious peer-reviewed journal JAMA Oncology of our positive global Phase 2b clinical trial results with aldoxorubicin in first line STS, and poster presentations regarding aldoxorubicin in Kaposi’s sarcoma and small cell lung cancer. Together, these results and presentations continue to strengthen the case for aldoxrobucin’s potential to become an important new treatment available for oncologists and their patients.”
Third Quarter 2015 and Recent Highlights
Announced the Publication of Phase 2b Clinical Trial Results for Soft Tissue Sarcoma in the Peer-Reviewed Journal JAMA Oncology. In September 2015, JAMA Oncology, the prestigious peer-reviewed Journal of the American Medical Association (JAMA), published a paper entitled “First-Line Aldoxorubicin vs Doxorubicin in Metastatic or Locally Advanced Unresectable Soft-Tissue Sarcoma: A Phase 2b Randomized Clinical Trial.” This paper discusses the design, methodology and results from CytRx’s completed multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in patients with metastatic or locally advanced unresectable STS. The results suggest that aldoxorubicin is the first single-agent therapy to show significantly superior efficacy over doxorubicin. Additionally, patients treated with aldoxorubicin did not exhibit evidence of acute cardiotoxicity. The full article can be accessed here.
Presented Posters on Aldoxorubicin for Kaposi’s Sarcoma (KS) and Small Cell Lung Cancer (SCLC). In July 2015, interim data on from the Phase 2 clinical trial of aldoxorubicin as a treatment for Kaposi’s sarcoma were presented at the 18th International Workshop on Kaposi’s Sarcoma Herpesvirus (KSHV) and Related Agents. Aldoxorubicin treatment resulted in tumor shrinkage and reductions of KS viral load. Importantly, tumor biopsies demonstrated that aldoxorubicin was present in the KS tumors. In September 2015, at the 16th World Congress on Lung Cancer in Denver, Colorado, CytRx presented the design for the ongoing comparative global Phase 2b trial in patients with metastatic SCLC who have either relapsed or were refractory to prior chemotherapy. The global Phase 2b trial is currently enrolling 132 patients at 37 sites in the USA, Hungary and Spain.
Upcoming Presentation of Additional Results from the Phase 1b/2 Clinical Trial Combining Aldoxorubicin with Ifosfamide/Mesna. At the 20th Annual Connective Tissue Oncology Society (CTOS) Annual Meeting in Salt Lake City, Utah, on November 4-7, CytRx will present the trial design and current results of its combination dose escalation trial in patients with metastatic soft and non-soft tissue sarcomas. To date, 7 subjects received 170 mg/m2 aldoxorubicin, and 3 subjects received 250 mg/m2 aldoxorubicin (125 or 185 mg/m2 doxorubicin equivalents), administered intravenously every 4 weeks. All patients also received 1 gram/m2/day ifosfamide/mesna administered as a continuous infusion for up to 14 days, every 4 weeks. As of September 30, 2015, 8 subjects demonstrated tumor shrinkage, with 3 subjects having documented partial responses. Six subjects are still receiving treatment. Grade 3 or 4 adverse events included neutropenia (90%), anemia (70%), nausea or vomiting (10%) and febrile neutropenia (10%). No subject exhibited cardiotoxicity by echocardiogram.
Expansion of Phase 1b Clinical Trial Combining Aldoxorubicin with Gemcitabine. CytRx recently added two additional treatment cohorts as part of the ongoing trial evaluating aldoxorubicin and gemcitabine in patients with metastatic solid tumors. This trial aims to find the optimal doses of each drug when given together, and to preliminarily evaluate the efficacy of the combination therapy. Nineteen patients have been randomized to date and results are expected in 2016.
Upcoming Milestones
- Complete enrollment in the first quarter of 2016 in the ongoing pivotal global Phase 3 clinical trial of aldoxorubicin as a second-line treatment for STS under a Special Protocol Assessment, or SPA, granted by the FDA, with PFS data announced in the second half of 2016
- Report updated results on the ongoing Phase 2 clinical trial of aldoxorubicin in patients with unresectable glioblastoma multiforme this quarter
- Complete enrollment in the aldoxorubicin global Phase 2b trial in second-line SCLC in the second quarter of 2016, with results in the second half of 2016
- Announce a new oncology pipeline drug candidate utilizing CytRx’s novel LADR technology this quarter
Third Quarter 2015 Financial Results
CytRx reported cash, cash equivalents and short-term investments of $70.8 million as of September 30, 2015.
Net loss for the three months ended September 30, 2015 was $7.1 million, or $0.11 per share, compared with a net loss of $5.6 million, or $0.10 per share, for the three months ended September 30, 2014. The increase of $1.5 million in net loss during the current three-month period resulted primarily from a reduction in the gain on warrant derivative liability, which was $3.5 million in the current quarter, as compared to $7.3 million in the comparative 2014 period, for a difference of $3.8 million.
Research and development (R&D) expenses were $8.5 million for the third quarter of 2015, and included development expenses of $6.8 million for aldoxorubicin and $0.4 million for CytRx’s German laboratory operations. The remaining $1.3 million of R&D expenses were primarily related to research and development support costs, including non-cash employee stock option expenses.. R&D costs were $10.6 million for the third quarter of 2014.
General and administrative (G&A) expenses were $2.2 million for the third quarter of 2015, compared with $2.4 million for the second quarter of 2014. G&A expenses for the third quarter of 2015 included non-cash employee stock-compensation expense of $0.5 million, compared to $0.4 million for the same period in 2014.
About Soft Tissue Sarcoma
Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.
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 will be diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.
About Glioblastoma Multiforme
Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. The median survival after diagnosis is approximately 14 months, despite patients subsequently receiving surgical resection, radiotherapy and chemotherapy.
To read full press release, please click here.
Help employers find you! Check out all the jobs and post your resume.
