LOS ANGELES, Oct. 2, 2017 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today provided a business update and highlighted the Company's future plans.
Aldoxorubicin for the Treatment of Soft Tissue Sarcomas and Other Oncology Indications
During 2017, CytRx has made significant strides in advancing its lead oncology asset aldoxorubicin from a late-stage clinical asset to a partnered, pre-New Drug Application (NDA) candidate in the U.S. In July 2017, CytRx announced a strategic licensing transaction with NantCell, Inc., for the global rights to aldoxorubicin. Dr. Patrick Soon-Shiong, the CEO and founder of NantCell, developed, obtained regulatory approval for, and commercialized Abraxane®, another albumin-mediated cytotoxic agent which currently generates approximately $1B in annual sales. CytRx believes that Dr. Soon-Shiong's track record and expertise with albumin-mediated agents will prove invaluable as NantCell works to obtain regulatory approval for aldoxorubicin, with the goal of commercialization thereafter.
"In addition to the initial indication of soft tissue sarcomas, NantCell is planning to develop aldoxorubicin in combination with immuno-oncology agents and cutting edge natural killer (NK) cell-based therapies in multiple tumor types, including breast and brain cancers," said David Haen, CytRx's Vice President of Business Development and Investor Relations. "NantCell is a true innovator in the field of oncology and brings a deep appreciation for the clinical benefit that aldoxorubicin can offer patients. We are confident that placing the asset in their hands will maximize both its future clinical and commercial potential."
CytRx has been actively working with the NantCell team to transition the aldoxorubicin program, including both completed and ongoing studies. Both teams are diligently working toward the preparation of the NDA for aldoxorubicin as a new treatment for soft tissue sarcomas, as well as getting additional clinical trials underway. CytRx looks forward to seeing aldoxorubicin enter NantCell-initiated clinical trials in the near future.
LADR™ Technology Platform and CytRx's Future Oncology Pipeline
CytRx's internal R&D activities at its expanded laboratory in Freiberg, Germany, are now focused on developing new drug candidates generated from its proprietary LADR™ (Linker Activated Drug Release) discovery platform.
Ongoing preclinical data is being generated for several LADR™-derived ultra-high potency compounds, and CytRx researchers have obtained partial and complete responses in a variety of solid tumor animal models to date. Additional in vivo efficacy and toxicology testing is underway, and CytRx's goal is to file one or more new patent applications during the fourth quarter of 2017. The Company also hopes to nominate the next LADR™ candidate for clinical development by the end of 2017 and to submit these important preclinical data for presentation at an upcoming scientific meeting in 2018. CytRx is extremely eager to move these programs forward and is taking great care to select the correct clinical candidates in order to optimally position these molecules for success once they enter clinical trials.
CytRx's strategy is to pursue a two-pronged approach to advancing its ultra-high potency LADR™ conjugates. Once a candidate is selected for clinical testing, the Company will conduct the necessary preclinical studies to enable an Investigational New Drug (IND) application filing, with the goal of taking the first LADR™-discovered, ultra-high potency conjugate into clinical trials during 2018. If the selected conjugate is successful in early-stage clinical studies although there can be no guarantee, CytRx hopes to seek Breakthrough Designation from the FDA. In parallel with internally advancing its LADR™-discovered conjugates, the Company also plans to explore pre-clinical strategic alliances with large pharmaceutical partners where a collaboration could demonstrate the utility of the LADR™ platform.
Corporate and Financial
For a non-revenue-generating, development-stage life science company, a strong balance sheet will always be a key concern. CytRx ended the second quarter of 2017 with $55 million in cash. Subsequent to the close of the second quarter, the NantCell transaction brought in an additional $13 million through their purchase of CytRx common shares at $1.10 per share, an approximately 92% premium to the Company's stock price at that time. The Company also restructured and paid down $10 million of its existing debt during the third quarter.
Mr. Haen concluded, "The grim reality is that 5-year survival rates for many cancers are still well below 50%. As a result, the Company's long-term goals have not changed, and that is to develop breakthrough oncology drugs to help provide new therapies for patients with cancer."
About CytRx Corporation
CytRx Corporation is a biopharmaceutical company specializing in research and clinical development of novel anti-cancer drug candidates that employ linker technologies to enhance the accumulation and release of drug at the tumor. Aldoxorubicin, CytRx's most advanced drug conjugate, is an improved version of the widely used chemotherapeutic agent doxorubicin and has been out-licensed to NantCell, Inc. CytRx is also rapidly expanding its pipeline of ultra-high potency oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx's expertise in albumin biology and linker technology for the development of a new class of potential breakthrough anti-cancer therapies.
This press release contains forward-looking statements. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks and uncertainties relating to: the ability of NantCell, Inc., to obtain regulatory approval for its products that use aldoxorubicin; the ability of NantCell Inc. to manufacture and commercialize products or therapies that use aldoxorubicin; the amount, if any, of future milestone and royalty payments that we may receive from NantCell; our ability to develop new ultra-high potency drug candidates based on our LADRTM technology platform; and other risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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