Los Angeles, CA, United States
Los Angeles, CA, United States

CytRx Corp. is a biopharmaceutical research and development oncology company based in Los Angeles, California.The CytRx oncology pipeline includes three programs in clinical development: bafetinib, tamibarotene and INNO-206. The company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia , a pharmacokinetic clinical trial in brain cancer and the PROACT Phase 2 clinical trial in advanced prostate cancer. With its tumor-targeting pro-drug candidate INNO-206, CytRx is conducting a safety trial with plans to initiate Phase 2 proof-of-concept clinical trials as a treatment for soft-tissue sarcomas and pancreatic cancer. CytRx's pipeline also includes tamibarotene, which it is testing in patients with non-small-cell lung carcinoma and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia .Arimoclomol is an experimental drug developed by CytRx. The orally administered drug is intended to treat amyotrophic lateral sclerosis , also known as Lou Gehrig's Disease.Steven Arthur Kriegsman is the President and CEO. Wikipedia.

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Daniel Levitt, M.D., Ph.D., Chief Operating Officer and Chief Medical Officer of CytRx, commented, "The data from both of these important clinical trials evaluating aldoxorubicin in sarcomas, along with our several other completed clinical and preclinical studies, will form the basis of our planned New Drug Application submission to the U.S. Food and Drug Administration, and we are pleased to share these more mature and detailed results in this peer-reviewed forum with the medical and scientific communities." Details for the presentations at ASCO 2017: Title: Phase III study of aldoxorubicin vs investigators' choice as treatment for relapsed/refractory soft tissue sarcomas Presenter: Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, and Principal Investigator Abstract #: 11000 Session Title: Oral Abstract Session: Sarcoma Location: S100bc Date and Time: Friday, June 2, 2017; 3:00pm-6:00pm CT Summary:  This multicenter, randomized, open-label Phase 3 trial enrolled 433 patients at 79 sites.  The data summarized here are as of August 2016.  In patients with leiomyosarcoma and liposarcoma (n=246), aldoxorubicin demonstrated median progression-free survival (PFS) of 5.32 months, compared to a median PFS of 2.96 months for investigator's choice therapy, a statistically significant improvement of 2.36 months (p=0.007; hazard ratio (HR)=0.62, 95% CI 0.44-0.88), representing a 38% reduction in the risk of tumor progression.  In patients treated in North America plus Australia (n=312), aldoxorubicin demonstrated a median PFS of 4.21 months, compared to a median PFS of 2.96 months for investigator's choice therapy, a statistically significant improvement of 1.25 months (p=0.023, HR=0.71, 95% CI 0.53-0.96).  In the overall intent to treat (ITT) trial population (n=433), aldoxorubicin performed better than investigator's choice demonstrating a median PFS of 4.11 months, compared to a median PFS of 2.96 months for investigator's choice therapy, narrowly missing statistical significance (p=0.087; HR=0.81, 95% CI 0.64-1.03).  All responses in this study were determined by an independent, blinded central lab assessment of scans. Key safety findings included that aldoxorubicin caused no clinically significant cardiac, renal, or hepatic toxicities.  Aldoxorubicin administered at 350mg/m2 per cycle showed no cardiotoxicity up to 40 cycles.  Importantly, left ventricular ejection fraction (LVEF) below 50% of expected values were reported in 4.2% of patients treated with aldoxorubicin, compared to 19.1% for patients receiving investigator's choice.  Additionally, ≥20% decreases in LVEF from baseline were reported in 3.8% of patients treated with aldoxorubicin, compared to 8.5% for patients receiving investigator's choice.  For the global trial population, the most commonly reported (≥10%) Grade ≥3 adverse events were neutropenia, anemia, febrile neutropenia, stomatitis and decreased white blood cell count, and were manageable with standard supportive care.  The non-cardiac Grade ≥3 adverse events associated with aldoxorubicin were similar to doxorubicin despite exposure up to 3-4 times the standard doxorubicin dose. Updated data relating to the trials other secondary endpoints, including objective response rate (ORR), disease control rate (DCR), overall survival, and other safety parameters were in line with what has previously been reported by CytRx and will be included in the oral presentation being given at ASCO 2017. Following conclusion of Dr. Chawla's presentation, a PDF copy of the oral presentation slides will be available at http://cytrx.com/investors/presentations. Title: Administration of aldoxorubicin and 14 days continuous infusion of ifosfamide/Mesna in metastatic or locally advanced sarcomas Presenter: Frederick C. Eilber, M.D., Director of the UCLA Sarcoma Translational Research Program within the Jonsson Comprehensive Cancer Center Abstract #: 11051 Session Title: Poster Session: Sarcoma Location: Hall A Poster board#: 374 Date and Time:  Sunday, June 4, 2017; 8:00am-11:30am CT Summary:  This ongoing open-label Phase 1/2 clinical trial is designed to assess the preliminary safety and activity of aldoxorubicin plus I-M as a first- or second-line treatment in patients with STS.  Patients were administered 1 of 2 dose levels of aldoxorubicin (170mg/m2 or 250mg/m2 [125mg/m2 or 185mg/m2 doxorubicin equivalent]) on Day 1, then I-M (1g/m2 of each per day) was administered for up to 14 days as a continuous infusion.  Chemotherapy cycles were repeated at 28 day intervals, but I-M was limited to a maximum of 6 cycles to avoid cumulative bone marrow toxicity.  Aldoxorubicin was continued per investigator decision in either responding or stable disease (SD) patients.  Patients were followed for tumor response by CT scans and echocardiogram for cardiac toxicity every 8 weeks along with standard labs. Of the 44 evaluable patients as of May 10, 2017, 16 patients (36%) achieved a partial response (PR), 25 patients (57%) achieved SD, with 20 patients (45%) achieving SD for ≥4 months, for an overall disease control rate (DCR) of 82% (PR+SD≥4).  Twenty-two of 44 (50%) patients received at least 6 cycles of aldoxorubicin (>1,300 mg/m2 cumulative doxorubicin equivalent).  As of the data cutoff date, the median PFS had not been reached.  The most commonly reported Grade ≥3 adverse event (AEs; >20%) were neutropenia and anemia.  Reported serious adverse events (SAEs) included febrile neutropenia (14%, n=6), anemia (5%, n=2), thrombocytopenia (2%, n=1), stomatitis (2%, n=1) and pyrexia (2%, n=1).  No clinically significant cardiotoxicity has been observed and no patients had a clinically significant decrease in LVEF or QTc prolongation, despite administration of median cumulative doses of doxorubicin equivalents of 1364-1965mg/m2.  No treatment related deaths occurred.  These results support the thesis that aldoxorubicin can be administered safely and for prolonged periods with continuous infusion I-M and achieves high response rates and SD, with substantial tumor necrosis.  Based on these results, the decision was made to stop further aldoxorubicin dose escalation and continue to enroll only in the 250mg/m2 cohort. Following conclusion of the poster presentation, a PDF copy of the poster will be available at http://cytrx.com/investors/presentations. Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue.  It can arise anywhere in the body at any age.  STS remains a high unmet medical need because of the difficulty in treating the more than 50 types of this aggressive cancer.  According to the American Cancer Society, in 2016 more than 12,300 new cases were diagnosed in the U.S. and approximately 5,000 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. Aldoxorubicin is a rationally-engineered cytotoxic which combines doxorubicin, a widely used chemotherapeutic agent, with a novel linker molecule that binds directly and specifically to circulating albumin, the most abundant protein in the bloodstream.  Protein-hungry tumors concentrate albumin, which facilitates the delivery of the linker molecule with the attached doxorubicin to tumor sites.  In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. Typically, doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Using this acid-sensitive linker technology, aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4 times). To date, there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 6,500 mg/m2 of doxorubicin equivalents. Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized clinical trial in first-line STS. 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 expanding 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. 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 preparation and submission of an NDA for aldoxorubicin for the treatment of STS and FDA acceptance and review of any NDA, the risk that CytRx may be unsuccessful in obtaining FDA approval or, if approval is obtained, in commercializing aldoxorubicin in the United States or elsewhere, 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. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cytrx-to-present-global-phase-3-aldoxorubicin-clinical-data-in-patients-with-soft-tissue-sarcomas-at-the-2017-american-society-of-clinical-oncology-annual-meeting-300459626.html


"We are excited to forge this new relationship with NantCell. They are committed not just to bringing aldoxorubicin to the market for patients with soft tissue sarcomas, but to expand aldoxorubicin's potential use in combination with both immuno-oncology and cell based therapies to better serve patients suffering from cancer," said Steven A. Kriegsman, CytRx's Chairman and Chief Executive Officer.  "This license and strategic investment will put aldoxorubicin in the hands of a committed partner who pioneered the development of albumin based chemotherapeutics, and will allow CytRx to continue to create new ultra-high potency drug candidates based on our LADR™ technology platform. Aldoxorubicin will clearly benefit from the first-hand experience of the NantCell management team led by Dr. Patrick Soon-Shiong, who developed and gained regulatory approval under a 505(b)(2) pathway and commercialized Abraxane®, an albumin-mediated cytotoxic agent which currently grosses approximately $1 billion in annual sales." "Aldoxorubicin's distinct profile makes it the first anthracycline to allow for continuous dosing without increasing cardiac toxicity which would be beneficial for the 17 indications for which doxorubicin is currently approved and other indications where it could provide benefit," stated Dr. Soon-Shiong, NantCell's Chairman and Chief Executive Officer.  "We aim to rapidly incorporate aldoxorubicin into multiple treatment protocols for major tumor types like breast and brain cancers as well as sarcomas." Under the terms of the license agreement, NantCell made a strategic investment by purchasing $13 million of CytRx common stock at $1.10 per share, representing approximately a 92% premium to CytRx's most recent market price.  CytRx is entitled to receive up to an additional $343 million in milestone payments related to regulatory approvals and commercial milestones for aldoxorubicin.  In addition, CytRx will receive increasing double-digit royalties for sales of aldoxorubicin for soft tissue sarcomas and mid to high single digit royalties for all other indications.  NantCell will be responsible for all future development, manufacturing and commercialization expenses.  CytRx also issued NantCell a warrant to purchase up to 3 million shares of common stock at $1.10 over the next 18 months. Aldoxorubicin is a rationally-engineered cytotoxic which combines doxorubicin, a widely used chemotherapeutic agent, with a novel linker molecule that binds directly and specifically to circulating albumin, the most abundant protein in the bloodstream.  Protein-hungry tumors concentrate albumin, which facilitates the delivery of the linker molecule with the attached doxorubicin to tumor sites.  In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. Typically, doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Using this acid-sensitive linker technology, aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4 times). To date, there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 6,500 mg/m2 of doxorubicin equivalents. Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized clinical trial in first-line soft tissue sarcomas. In addition, CytRx has amended its long-term loan facility and will make a payment of $5 million to the lender upon the closing of the exclusive global license and strategic investment for aldoxorubicin. CytRx was represented by Skadden, Arps, Slate, Meagher & Flom LLP on the global license and strategic investment. NantCell, an entity controlled by Dr. Patrick Soon-Shiong, is an immuno-oncology company focused on the discovery of innovative antibody, T cell and NK cell based treatments by developing molecularly targeted therapeutics, based on the proteomic profile of the patient's tumor, independent of the cancer's anatomical type. NantCell's mission is to make obsolete the standard method of clinical trial design of "trial and error" and replace it with a level of quantitative predictability based on both the genomic and proteomic profile performed a priori. The Company will tap into comprehensive "omic" analytic tools and "big data" generated from supercomputing to develop molecularly designed drugs in this era of genomics and proteomics and identify patients and their tumor signature at the most granular cellular, DNA and protein levels. Patients entering clinical trials would be identified after a comprehensive "omic" analysis from tissue to cell to DNA to RNA to protein to peptide to drug, and tested based on this molecular profile to maximize clinical outcome and minimize side effects.  Through these integrated diagnostic methods, the company is pursuing the vision of treating the biology of cancer rather than the anatomy, and drive the immune system inherited by all to defeat cancer.  For more information please visit www.nanthealth.com and follow Dr. Soon-Shiong on Twitter @Dr.PatSoonShiong. 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.  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.


News Article | August 3, 2017
Site: www.prnewswire.com

"We are very proud of the tireless work undertaken over the past several months to secure a high-value, strategic partnership with NantCell Inc. which charts the best path forward for aldoxorubicin, through both expansion into multiple tumor types beyond soft tissue sarcomas (STS) and innovative combinations with immuno-oncology and cell-based therapies," said Steven A. Kriegsman, CytRx's Chairman and CEO.  "We believe NantCell has the vision and expertise to maximize aldoxorubicin's potential and bring it to the patients and physicians who need it.  Looking ahead for CytRx, we are rapidly expanding our pipeline of ultra-high potency oncology candidates at our laboratory in Freiburg, Germany, using our 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." Entered an Exclusive Global Licensing Agreement and Strategic Investment with NantCell for Aldoxorubicin. Last week, CytRx and NantCell, Inc. (a private subsidiary of NantWorks, LLC) executed a global strategic licensing agreement giving exclusive rights to NantCell to develop and commercialize aldoxorubicin for all indications.  The NantCell team is led by Dr. Patrick Soon-Shiong, who developed, gained regulatory approval under a 505(b)(2) pathway, and commercialized Abraxane®, an albumin-mediated cytotoxic agent which currently grosses approximately $1 billion in annual sales.  Under the terms of the agreement, NantCell purchased $13 million of CytRx common stock at a per share price of $1.10 representing approximately a 92% premium to the current market price.  CytRx is eligible to receive up to an additional $343 million in regulatory and commercial milestones, plus increasing double-digit royalties on sales in aldoxorubicin's lead indication of soft tissue sarcomas, and mid to high single-digit royalties for any additional indications.  CytRx also issued NantCell a warrant to purchase up to 3 million shares of common stock at $1.10 over the next 18 months. Amended Long-Term Loan Facility.  In conjunction with the NantCell transaction, CytRx amended its long-term loan facility and made a payment of $5 million to the lender upon the closing of the exclusive global license and strategic investment for aldoxorubicin. Appointed Dr. Shanta Chawla Senior Vice President of Drug Development. In June 2017, CytRx announced the appointment of Shanta Chawla, M.D., as the Senior Vice President of Drug Development. Dr. Chawla has served as Vice President of Clinical Development for three years and will assume the leadership of CytRx's clinical and regulatory functions. Presented Aldoxorubicin Clinical Trial Data in Patients with Soft Tissue Sarcomas (STS) at the 2017 American Society of Clinical Oncology Annual Meeting (ASCO).  In June 2017, CytRx presented results from its global Phase 3 clinical trial evaluating aldoxorubicin versus investigators' choice in patients with relapsed and refractory STS (n=246) at ASCO 2017.  An oral presentation given by Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica and principal investigator, described how aldoxorubicin demonstrated median progression-free survival (PFS) of 5.32 months, compared to a median PFS of 2.96 months for investigator's choice therapy, a statistically significant improvement of 2.36 months (p=0.007; hazard ratio (HR)=0.62, 95% CI 0.44-0.88), representing a 38% reduction in the risk of tumor progression.  In patients treated in North America plus Australia (n=312), aldoxorubicin demonstrated a median PFS of 4.21 months, compared to a median PFS of 2.96 months for investigator's choice therapy, a statistically significant improvement of 1.25 months (p=0.023, HR=0.71, 95% CI 0.53-0.96).  In the overall intent to treat (ITT) trial population (n=433), aldoxorubicin performed better than investigator's choice demonstrating a median PFS of 4.11 months, compared to a median PFS of 2.96 months for investigator's choice therapy, narrowly missing statistical significance (p=0.087; HR=0.81, 95% CI 0.64-1.03).  All responses in this study were determined by an independent, blinded central lab assessment of scans. Presented Aldoxorubicin and Ifosfamide/Mesna Combination Trial Data in Patients with Metastatic or Locally Advanced Sarcomas at ASCO. In June 2017, CytRx presented updated data from its ongoing Phase 1/2 clinical trial combining aldoxorubicin with ifosfamide/mesna in patients with first-line soft tissue sarcomas at ASCO 2017.  Of the 44 evaluable patients as of May 10, 2017, 16 patients (36%) achieved a partial response (PR), 25 patients (57%) achieved SD, with 20 patients (45%) achieving SD for ≥4 months, for an overall disease control rate (DCR) of 82% (PR+SD≥4).  Twenty-two of 44 (50%) patients received at least 6 cycles of aldoxorubicin (>1,300 mg/m2 cumulative doxorubicin equivalent).  As of the data cutoff date, the median PFS had not been reached. Completed $15 Million Financing.  In May 2017, CytRx closed the sale of 30 million shares of common stock in a public offering at a price of $0.50 per share, resulting in net proceeds of approximately $14.0 million after deducting placement agent's fees and other estimated offering expenses.  Additionally, the Company received approximately $2.8 million from the exercise of warrants resulting in a total raise of $16.8 million in the second quarter.  Subsequent to the end of the second quarter, 6.3 million warrants with a strike price of $0.70 expired on July 19, 2017. CytRx reported cash, cash equivalents and short-term investments of $55.0 million as of June 30, 2017. Subsequent to the close of the quarter, CytRx entered into a global strategic licensing agreement for aldoxorubicin with NantCell Inc., and received a strategic investment of $13.0 million.  Concurrent with the closing of the aldoxorubicin license agreement, CytRx amended its existing long-term loan and made a payment of $5 million to the lender. On May 2, 2017, CytRx completed a public offering of 30 million shares of its common stock at a price of $0.50 per share.  The net proceeds to CytRx from the offering, after deducting placement agent's fees and other estimated offering expenses, were approximately $14.0 million.  In addition, CytRx received $2.8 million in proceeds from the exercise of warrants in the second quarter of 2017. Net loss for the quarter ended June 30, 2017, was $14.4 million, or $(0.10) per share, compared with a net loss of $18.3 million, or $(0.27) per share, for the quarter ended June 30, 2016, a reduction of $3.9 million.  During the second quarter of 2017, the Company recognized a non-cash loss of $4.3 million on the fair value adjustment of warrant derivative liability related to warrants issued in 2016, compared to a non-cash gain of $0.9 million during the second quarter of 2016 related to now expired warrants. Research and development (R&D) expenses were $6.2 million for the second quarter of 2017, and included development expenses of $3.7 million for aldoxorubicin, approximately $0.9 million for pre-clinical development of new albumin-binding, ultra-high potency cancer drugs (German lab), and approximately $1.6 million for non-cash expenses and general operation of our clinical programs.  This is a reduction of approximately 50 percent compared to R&D expenses of $12.5 million for the second quarter of 2016. General and administrative (G&A) expenses were $3.1 million for the second quarter of 2017, compared with $6.1 million for the second quarter of 2016, a reduction of $3 million. 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 LADR™ 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.


News Article | May 10, 2017
Site: www.prnewswire.com

"Finally, we look forward to presenting the more detailed and updated global Phase 3 STS results to the medical community at the upcoming 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.  This Phase 3 trial, along with the combination trial of aldoxorubicin with ifosfamide/mesna, continue to build upon the body of clinical data supporting aldoxorubicin's potential as a new and better treatment for patients with STS," Mr. Kriegsman commented. Strengthened the Balance Sheet with $15 Million in Financing and $2 Million in Warrant Proceeds.  In early May 2017, CytRx completed the sale of approximately 30 million shares of common stock in a public offering at a price of $0.50 per share, resulting in net proceeds to the Company of approximately $13.9 million after deducting placement agent's fees and other estimated offering expenses.  Additionally, the Company received approximately $1.9 million from the exercise of warrants resulting in a total raise of $15.8 million subsequent to March 31, 2017. Concluded Phase 3 Trial Evaluating Aldoxorubicin in Relapsed or Refractory STS.  Based on its goal to submit a rolling NDA, subject to approval from the FDA, the Company has concluded its Phase 3 study evaluating aldoxorubicin compared to investigator's choice in patients with relapsed or refractory STS. Aldoxorubicin Clinical Trial Data in Patients with STS Selected for Oral Presentation at the 2017 American Society of Clinical Oncology Annual Meeting (ASCO).  In April 2017, CytRx announced that an abstract describing results from its global Phase 3 clinical trial evaluating aldoxorubicin versus investigators' choice in patients with relapsed and refractory STS was selected for an oral presentation at ASCO 2017, taking place June 2-6, 2017 in Chicago.  The oral presentation (abstract #11000) will be given by Principal Investigator, Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, on Friday, June 2, 2017 between 3:00-6:00 pm CT.  In addition to the STS presentation, a poster (abstract #11051) highlighting updated data from CytRx's ongoing Phase 1/2 clinical trial combining aldoxorubicin with ifosfamide/mesna in patients with first-line soft tissue sarcomas will also be presented by Frederick C. Eilber, M.D., Director of the UCLA Sarcoma Translational Research Program within the Jonsson Comprehensive Cancer Center, on Sunday, June 4, 2017 between 8:00-11:00 am CT. Announced FDA Agreement on Regulatory Pathway to Approval for Aldoxorubicin in STS.  In April 2017, CytRx announced that it had reached an agreement with the FDA on the pathway for a NDA submission for aldoxorubicin as a treatment for STS.  The Company's goal is to submit a rolling NDA under section 505(b)(2) to the FDA in the fourth quarter of 2017.  The commercial launch of aldoxorubicin is projected for 2018 in the U.S.  Aldoxorubicin has received Orphan Drug Designation from the FDA for the treatment of STS, which provides for several benefits including seven years of market exclusivity after approval, certain R&D related tax credits and protocol assistance from the FDA.  CytRx also plans to discuss with the European Medicines Agency a path to filing a Marketing Authorization Application.  European regulators granted aldoxorubicin Orphan Medicinal Product Designation for STS which confers ten years of market exclusivity among other benefits. On May 2, 2017, CytRx completed a public offering of 30 million shares of its common stock at a price of $0.50 per share.  The net proceeds to CytRx from the offering, after deducting placement agent's fees and other estimated offering expenses, were approximately $13.9 million.  In addition, CytRx received $1.9 million in proceeds from the exercise of warrants in April and May 2017. Net loss for the quarter ended March 31, 2017, was $11.0 million, or $(0.10) per share, compared with a net loss of $12.6 million, or $(0.19) per share, for the quarter ended March 31, 2016.  During the first quarter of 2017, the Company recognized a non-cash loss of $0.03 million on the fair value adjustment of warrant derivative liability related to warrants issued in 2016, compared to a non-cash loss of $0.2 million during the first quarter of 2016 related to now expired warrants. Research and development (R&D) expenses were $6.8 million for the first quarter of 2017, and included development expenses of $4.0 million for aldoxorubicin, approximately $0.6 million for pre-clinical development of new albumin-binding, ultra-high potency cancer drugs (German lab), and approximately $2.2 million for general operation of our clinical programs.  R&D expenses were $8.2 million for the first quarter of 2016. General and administrative (G&A) expenses were $3.0 million for the first quarter of 2017, compared with $4.0 million for the first quarter of 2016. 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 expanding 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. This press release contains forward-looking statements. Such statements are not promises or guarantees, and involve numerous risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements.  These risks include: the timing and final results of CytRx's clinical testing of aldoxorubicin; timing of CytRx's preparation and submission of an NDA for aldoxorubicin for the treatment of STS and FDA acceptance and review of any NDA; the risk that CytRx may be unsuccessful in obtaining FDA approval or, if approval is obtained, in commercializing aldoxorubicin in the United States or elsewhere; risks related to CytRx's need for and ability to raise additional capital or enter into strategic partnerships to fund its ongoing working capital needs and development efforts; 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 relating to preclinical testing of CytRx's LADR™ linker technology platform; risks related to pending lawsuits against CytRx and its officers and directors; and the other risks and uncertainties described in CytRx's Annual Report on Form 10-K for the year ended December 31, 2016 filed with the Securities and Exchange Commission. 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. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cytrx-reports-first-quarter-2017-financial-results-300455045.html


Glass Lewis is widely recognized as one of the leading independent proxy voting and corporate governance advisory firms, and its recommendations are relied upon by thousands of major institutional investment firms, mutual funds and other fiduciaries throughout the United States. In its report dated September 20, 2017, Glass Lewis stated, "We agree with the board that it is in the best interest of the Company to reduce the number of shares of common stock outstanding and thereby attempt to proportionally raise the per share price of the Company's common stock....  A higher stock price may help to increase investor interest, attract and retain employees."1 In response to the favorable recommendation, Dr. Louis Ignarro, Nobel Laureate and Lead Director of CytRx said, "We are pleased that Glass Lewis, a highly regarded, independent, leading proxy advisory firm understands the importance of maintaining a NASDAQ Global Market listing and increasing our common stock price to a level that allows us to attract a broader and more diverse shareholder base." CytRx stockholders are urged to vote as Glass Lewis recommends by voting "FOR" the proposed reverse stock split.  Stockholders with questions may call Saratoga Proxy Consulting LLC at (888) 368-0379 or (212) 257-1311 or by email at info@saratogaproxy.com. 1Permission to use quotation was neither sought nor obtained. If you are a stockholder of record at the close of business on August 28, 2017, you can vote your shares in one of two ways: either by proxy or in person at the special meeting. If you chose to submit a proxy, you may do so by telephone, via the internet or by mail. If you hold shares of CytRx common stock in multiple accounts, you should vote your shares as described in each set of proxy materials you receive. CytRx highly recommends stockholders vote electronically or by phone without delay. Please have your proxy card with you while voting. You may transmit your proxy voting instructions via the Internet by accessing www.proxyvote.com and following the instructions. You may also transmit your proxy voting instructions by calling the telephone number specified on the proxy card. If you chose to vote via the Internet or phone, you do not have to return the proxy card. For stockholders who still need assistance voting their shares, or have questions regarding the special meeting, please contact CytRx's proxy solicitation firm, Saratoga Proxy Consulting, either by telephone: (888) 368-0379 or (212) 257-1311 or by email: info@saratogaproxy.com. This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed reverse stock split. STOCKHOLDERS ARE URGED TO READ CAREFULLY AND IN ITS ENTIRETY THE DEFINITIVE PROXY STATEMENT AND ANY AMENDMENTS FILED WITH THE SEC, AND OTHER RELEVANT MATERIALS, BECAUSE THEY DO AND WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY AND THE PROPOSED REVERSE STOCK SPLIT.  The definitive proxy statement was mailed to stockholders of record as of August 28, 2017.  The amended definitive proxy statement will be mailed to shareholders on or about September 13, 2017.  Stockholders may obtain free copies of the Company's definitive proxy statement, any amendments to the proxy statement and its other SEC filings electronically by accessing the SEC's home page at http://www.sec.gov.  Copies can also be obtained, free of charge, upon written request to CytRx Corporation, Attn: Corporate Secretary, 11726 San Vicente Blvd., Suite 650, Los Angeles, CA 90049. This press release may constitute soliciting material under SEC Rule 14a-12, and CytRx and its directors, executive officers, and advisors may be deemed to be participants in the solicitation of proxies from the holders of CytRx common stock in respect of the proposed reverse stock split.  Investors may obtain additional information regarding the interest of those participants by reading the Company's definitive proxy statement, any amendments to the definitive proxy statement and other relevant proxy materials, and the Company's annual reports on Form 10-K and quarterly reports on Form 10-Q, as filed with the SEC. 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 plans for regaining compliance with the NASDAQ rules and higher share price of our common stock; 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, Inc.; 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.


When the reverse stock split becomes effective, every six (6) shares of CytRx's pre-split common stock, will automatically be converted into one (1) share of post-split common stock.  The reverse stock split will affect all issued and outstanding shares of the Company's common stock immediately prior to the effective time of the reverse stock split, all employee stock options, as well as all other outstanding options and warrants. Accordingly, the Company's approximately 165.8 million pre-split shares of common stock outstanding will be combined into approximately 27.6 million post-split shares outstanding.  Following the reverse stock split, the 250 million authorized shares of common stock will be reduced to approximately 41.7 million shares.  The five million authorized preferred shares will be converted into approximately 0.8 million preferred shares.  There are no preferred shares currently outstanding. CytRx requested and was granted a hearing before a NASDAQ Hearings Panel to present its plan to regain compliance with the minimum $1.00 bid price requirement, which will be based upon the proposed reverse stock split.  The Company's common stock will continue to trade on NASDAQ under the symbol "CYTR" pending the conclusion of the hearing process. Additional information including frequently asked questions and answers concerning the proposed reverse stock split can be found on CytRx's website at www.cytrx.com/investors. If you are a stockholder of record at the close of business on August 28, 2017, you can vote your shares in one of two ways: either by proxy or in person at the special meeting. If you chose to submit a proxy, you may do so by telephone, via the internet or by mail. If you hold shares of CytRx common stock in multiple accounts, you should vote your shares as described in each set of proxy materials you receive. CytRx highly recommends stockholders vote electronically or by phone without delay. Please have your proxy card with you while voting. You may transmit your proxy voting instructions via the Internet by accessing www.proxyvote.com and following the instructions. You may also transmit your proxy voting instructions by calling the telephone number specified on the proxy card. If you chose to vote via the Internet or phone, you do not have to return the proxy card. For stockholders who still need assistance voting their shares, or have questions regarding the special meeting, please contact CytRx's proxy solicitation firm, Saratoga Proxy Consulting, either by telephone: (888) 368-0379 or (212) 257-1311 or by email: info@saratogaproxy.com. This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed reverse stock split. STOCKHOLDERS ARE URGED TO READ CAREFULLY AND IN ITS ENTIRETY THE DEFINITIVE PROXY STATEMENT AND ANY AMENDMENTS FILED WITH THE SEC, AND OTHER RELEVANT MATERIALS, BECAUSE THEY DO AND WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY AND THE PROPOSED REVERSE STOCK SPLIT.  The definitive proxy statement was mailed to stockholders of record as of August 28, 2017.  The amended definitive proxy statement will be mailed to shareholders on or about September 13, 2017.  Stockholders may obtain free copies of the Company's definitive proxy statement, any amendments to the proxy statement and its other SEC filings electronically by accessing the SEC's home page at http://www.sec.gov.  Copies can also be obtained, free of charge, upon written request to CytRx Corporation, Attn: Corporate Secretary, 11726 San Vicente Blvd., Suite 650, Los Angeles, CA 90049. This press release may constitute soliciting material under SEC Rule 14a-12, and CytRx and its directors, executive officers, and advisors may be deemed to be participants in the solicitation of proxies from the holders of CytRx common stock in respect of the proposed reverse stock split.  Investors may obtain additional information regarding the interest of those participants by reading the Company's definitive proxy statement, any amendments to the definitive proxy statement and other relevant proxy materials, and the Company's annual reports on Form 10-K and quarterly reports on Form 10-Q, as filed with the SEC. 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 plans for regaining compliance with the NASDAQ rules and higher share price of our common stock; 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, Inc.; 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.


SOUTH PLAINFIELD, NJ--(Marketwired - Feb 9, 2017) -  PolarityTE™, Inc. ( : COOL) today announced it has appointed Steve Gorlin to the Board of Directors. Mr. Gorlin has extensive experience building successful biotechnology companies, and is a leader in regenerative medicine, pharmaceutical drug and medical device research and development. "We are extremely excited to announce Steve Gorlin as a new member of the PolarityTE™ Board of Directors. With over 40 successful years in the field, he remains a leader and serial entrepreneur in regenerative medicine, biotechnology, and wound care. Having founded and managed a variety of cell therapy, pharmaceutical, and medical device companies, including MiMedx, EntreMed, Hycor, Medivation, Medicis and NantKwest, he is without a doubt a truly valuable innovator," said Denver Lough, MD, PhD, Chairman and CEO. Newly appointed board member, Steve Gorlin, remarked, "I could not be more enthusiastic to join the Polarity team and Board of Directors. I look forward to bringing the revolutionary regenerative technology of Polarity to every patient that it can benefit. Upon learning about the platform and team behind this company, I knew I was staring at a winner. The passion of Dr. Lough and his team is palpable, which is always a critical ingredient to any business endeavor, and especially in biotechnology. I understand why he and Dr. Swanson left their plastic surgery training program at Johns Hopkins to pursue this technology, because it is clear that they have the potential to impact many more lives with Polarity than they ever could achieve as surgeons." During December 2016 PolarityTE entered into an Agreement and Plan of Reorganization to acquire certain intellectual property rights developed by Dr. Lough. Completion of the acquisition is subject to a number of conditions, including stockholder approval. There can be no assurance that the conditions will be met or that the acquisition will be successful. The Acquisition, and our business generally, is subject to a number of risks that are more fully described under "Risk Factors" that appear in our filings and reports with the SEC. About Steve Gorlin Over the past 40 years, Mr. Gorlin has founded several biotechnology and pharmaceutical companies, including Hycor Biomedical, Inc. (acquired by Agilent), Theragenics Corporation, CytRx Corporation, Medicis Pharmaceutical Corporation (sold to Valeant for approximately $2.6 billion), EntreMed, Inc., MRI Interventions (MRIC), MiMedx, and Medivation, Inc. Mr. Gorlin has served on the Business Advisory Council to the Johns Hopkins School of Medicine and has previously served on The Johns Hopkins BioMedical Engineering Advisory Board. He also serves on the Board of the Andrews Institute. He founded a number of non-medical related companies, including Perma-Fix, Inc., Pretty Good Privacy, Inc. sold to Network Associates, Judicial Correction Services, Inc. sold to Correctional Healthcare, and NTC China. He started The Touch Foundation, a nonprofit organization for the blind and was a principal financial contributor to the founding of Camp Kudzu for diabetic children. He presently serves as the Vice Chairman of NantKwest, and serves on the Board of NTC China, Inc. About PolarityTE™, Inc. PolarityTE™, Inc. is the owner of a novel regenerative medicine and tissue engineering platform developed and patented by Denver Lough MD, PhD. This radical and proprietary technology employs a patients' own cells for the healing of full-thickness functionally-polarized tissues. If clinically successful, the PolarityTE™ platform will be able to provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient's own tissue substrates for the regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves. It is because PolarityTE™ uses a natural and biologically sound platform technology, which is readily adaptable to a wide spectrum of organ and tissue systems, that the company and its world-renowned clinical advisory board, are poised to drastically change the field and future of translational regenerative medicine. More information can be found online at www.polarityte.com. Forward Looking Statements Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this release relate to, among other things, the Company's ongoing compliance with the requirements of The NASDAQ Stock Market and the Company's ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. They are generally identified by words such as "believes," "may," "expects," "anticipates," "should'" and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company's beliefs and assumptions as of the date of this release. The Company's actual results could differ materially due to risk factors and other items described in more detail in the "Risk Factors" section of the Company's Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.


Patent
CytRx | Date: 2013-12-13

The invention relates to reconstituted formulations comprising an anthracycline compound, ethanol, and water. The invention also relates to injectable compositions comprising the reconstituted formulation and Lactated Ringers solution. Additionally, the invention relates to methods of using the formulations and compositions.


Patent
CytRx | Date: 2014-06-04

The present invention relates to a method of treating brain cancer comprising administering a therapeutically effective substance to a patient, wherein the therapeutically effective substance comprises: (I), or a pharmaceutically acceptable salt thereof, wherein X is a moiety that can be cleaved hydrolvtically or enzymaticaily in the body of the patient in a pH-dependent manner.


NEW YORK, March 2, 2017 /PRNewswire/ -- In today's pre-market research, Stock-Callers.com presents these Biotech equities for review: Halozyme Therapeutics Inc. (NASDAQ: HALO), CytRx Corp. (NASDAQ: CYTR), Cara Therapeutics Inc. (NASDAQ: CARA), and Keryx Biopharmaceuticals Inc....

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