CytRx Nominates Next Clinical Drug Candidate DK049

Positive Data Support Plans for Phase I Clinical Trial in Humans

IND Filing Planned for 2H 2016 for New Chemical Entity Using LADR™ Technology

Dec 07, 2015, 09:00 ET from CytRx Corporation

LOS ANGELES, Dec. 7, 2015 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that it has selected its next drug, designated DK049, for clinical development in 2016.  DK049 was created using CytRx's novel LADR™ (Linker-Activated Drug Release) technology that allows the drug to bind to albumin in the body's bloodstream and controls its release at the site of the tumor. The LADR™ technology used with DK049 employs a two-stage linker that utilizes both pH sensitivity and acts enzymatically to allow release of its cytotoxic drug payload which extends the duration of exposure in tumors. Prolonged inhibition of tumor growth has been demonstrated in human tumor xenograft models of pancreatic cancer, non-small cell lung cancer and ovarian cancer at doses that lack apparent toxicity.  As an example of the LADR™ technology's capability, human ovarian tumor xenograft models received 85% less drug than a known chemotherapy comparator, yet at the end of the study, DK049-treated tumors were an average 13 times smaller than the chemotherapy-treated animals.  These data have been submitted for presentation at the American Association of Cancer Research Annual Meeting in April 2016. Additionally, CytRx has applied for patents for both its LADR™ technology and DK049 itself.

"We believe that our LADR™ technology is the next advancement in linker-controlled drug release to be used with both antibody-drug conjugates and albumin-binding approaches, " commented Dr. Felix Kratz, Vice President of Drug Discovery at CytRx. "The ability to adjust the structure and composition of our linkers allows CytRx to attach a variety of lethal agents that include modified standard chemotherapies as well as highly potent agents currently used in antibody-drug conjugates."

"In only its first year, our Drug Discovery Group has created a technology that is capable of providing CytRx with a clinical pipeline for years to come," said Steven A. Kriegsman, Chairman and CEO of CytRx Corporation. "Their creation of DK049 was accomplished very rapidly due to the intelligent drug design and experience of Dr. Kratz's group. We are confident that their progress with the LADR™ technology will be a key value driver for CytRx in the future."

CytRx's LADR™ technology has several advantages over current linkers:

  • It allows prolonged drug exposure with accumulation at the site of the tumor.
  • The linker reduces drug release in healthy cells.
  • The controlled release allows delivery of payloads that are 10-1000 times more potent than standard chemotherapies.
  • The LADR™ conjugates can evade traditional drug resistance mechanisms.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin, its improved version of the widely used chemotherapeutic agent doxorubicin.  CytRx is also seeking to expand its pipeline of 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 anti-cancer therapies.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. 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 relating to the outcome, timing and results of CytRx's clinical testing of aldoxorubicin and preclinical testing of its LADR™ linker technology platform, the outcome, timing or results of CytRx's clinical testing of aldoxorubicin, the risk that any future pre-clinical or human testing of compounds based on the LADR™ technology platform might not show efficacy or reduced side effects of those compounds, risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 2 and Phase 3 clinical development of aldoxorubicin for SCLC and STS, respectively, and the preclinical and clinical development of compounds based on the LADR™ technology platform, risks related to lawsuits that have been brought against the Company and its officers and/or directors for alleged violations of the securities laws, and the 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.

Company Contact: CytRx Corporation David J. Haen Vice President, Business Development and Investor Relations (310) 826-5648, ext 304

Investor Relations: Alexander Capital, LP (855) 288-ALEX (2539)


SOURCE CytRx Corporation