CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today reported financial results for the 12 months ended December 31, 2013, and also provided an overview of recent accomplishments and upcoming milestones for its clinical development programs.
“CytRx achieved a number of important clinical milestones in the aldoxorubicin program in 2013, including the announcement of positive top-line results from our global Phase 2b clinical trial in soft tissue sarcoma (STS) and the initiation of two Phase 2 clinical trials in glioblastoma and Kaposi’s sarcoma,” said Steven A. Kriegsman, CytRx President and CEO. “We are entering 2014 on firm financial ground, having recently raised approximately $86 million, before deducting expenses, along with a cash balance of $38.5 million at year end 2013. With this strong balance sheet, we are well funded to execute on our corporate objectives for the foreseeable future.”
Mr. Kriegsman added: “Looking forward to 2014, we are well-positioned to commence our global Phase 3 pivotal trial of aldoxorubicin as a second-line treatment for STS, and are currently screening patients for entry in the trial. We are also expecting data readouts in the second half of the year from the ongoing Phase 2 clinical trial of aldoxorubicin in glioblastoma as well as updated results from our global Phase 2b trial of aldoxorubicin in first-line STS.”
2013 and Recent Highlights
Reported Positive Top-Line Results from Global Phase 2b Clinical Trial of Aldoxorubicin as First-Line Treatment for STS.
In December 2013, CytRx announced highly positive, top-line efficacy results from a multicenter, randomized, open-label global Phase 2b clinical trial. Aldoxorubicin demonstrated 80-100% superiority over doxorubicin in median progression-free survival (PFS), 6-month PFS and overall response rates (ORR). All efficacy results for the aldoxorubicin treatment arm were highly statistically significant compared with doxorubicin treatment.
Secured Special Protocol Assessment (SPA) from FDA for Global Pivotal Phase 3 Clinical Trial of Aldoxorubicin as Second-Line Treatment for Soft Tissue Sarcoma (STS).
In April 2013, CytRx announced it had reached an agreement with the U.S. Food and Drug Administration (FDA) under an SPA for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas who have relapsed or were refractory following prior treatment with chemotherapy. The SPA is a written agreement between the Company, as the trial’s sponsor, and the FDA regarding the design, endpoints and planned statistical analysis approach of the pivotal Phase 3 clinical trial to be used in support of a potential New Drug Application (NDA) for aldoxorubicin. In January 2014, the Company announced it has received approval from the FDA to amend the Phase 3 protocol to continue dosing patients with aldoxorubicin until disease progression (defined as an increase in the size of measurable tumors by 20% or the development of a new tumor lesion). This FDA decision reflects a level of comfort with the cardiac safety of aldoxorubicin as demonstrated in previous clinical trials. The Company believes that the additional treatment cycles create the potential for substantially improved Phase 3 efficacy results.
Initiated Phase 2 Clinical Trial of Aldoxorubicin in Patients with Unresectable Glioblastoma Multiforme.
In November 2013, CytRx announced the initiation of a Phase 2 clinical trial with the Company’s aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer. The open-label, multi-center study, which is expected to enroll up to 28 patients, is designed to investigate the preliminary efficacy and safety of aldoxorubicin in subjects with unresectable GBM whose tumors have progressed following prior treatment with surgery, radiation and temozolomide. The primary objective of this trial is to determine PFS and OS, and the principal secondary objective is an evaluation of the safety of aldoxorubicin in the study subjects.
Initiated Phase 2 Clinical Trial of Aldoxorubicin as a First-Line Treatment for AIDS-related Kaposi’s Sarcoma.
In January 2014, CytRx announced the initiation of a Phase 2 clinical trial to determine the preliminary efficacy and safety of aldoxorubicin for HIV-infected patients with Kaposi’s sarcoma (KS). This open-label study will be conducted at the Louisiana State University Health Sciences Center in New Orleans and is expected to enroll up to 30 patients.
Reported Highly Favorable Preclinical Data in a Model of Human Glioblastoma at ESMO 2013.
In September 2013 at the 2013 European Cancer Congress (ECCO/ESMO/ESTRO), CytRx presented preliminary preclinical study results which demonstrated that aldoxorubicin compared with doxorubicin produced statistically significant improvement in survival rates in animals with a human model of glioblastoma. Updated results are being presented at the American Association of Cancer Research (AACR) meeting in April, 2014.
Strengthened the Corporate Balance Sheet and Leadership Team.
In October 2013 and February 2014, CytRx successfully completed two public offerings of common stock securing gross proceeds of approximately $26 million and $86 million, respectively. CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures. In January 2014, the Company appointed Shanta Chawla, M.D. as Vice President, Clinical Development. Dr. Chawla brings more than 13 years of clinical research, operations and development experience, with a focus on oncology therapeutics and will support the Company’s upcoming global Phase 3 clinical trial of aldoxorubicin in STS.
Upcoming Major 2014 Milestones
Full Year 2013 Financial Results
- Initiate a global Phase 3 pivotal trial of aldoxorubicin as a second-line treatment for STS in the first quarter of 2014
- Announce preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin in Glioblastoma Multiforme in the second half of 2014
- Initiate a global Phase 2b clinical trial of aldoxorubicin as a second-line treatment for small cell lung cancer (SCLC) in the second half of 2014
- Announce OS results from its ongoing global Phase 2b clinical trial of aldoxorubicin as a first-line treatment for STS in the second half of 2014
- Expand the oncology pipeline by combining our novel linker platform technology with additional chemotherapeutic agents
CytRx reported cash, cash equivalents and short-term investments of $38.5 million as of December 31, 2013. On February 5, 2014, the Company completed a $86.0 million underwritten public offering, in which it sold and issued 13.2 million shares of common stock at a price of $6.50 per share. Net of underwriting discounts, legal, accounting and other offering expenses, the Company received proceeds of approximately $80.5 million.