cytrx corp (CYTR) Key Developments
CytRx Corporation Announces Results from its Ongoing Phase 2 Clinical Trial with Aldoxorubicin for the Treatment of Unresectable Glioblastoma Multiforme
May 21 15
CytRx Corporation announced positive updated results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme, a deadly form of brain cancer. The open-label, multisite trial is designed to investigate the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide. Study subjects have received between 1 and 14 cycles of aldoxorubicin, with 4 subjects continuing to receive aldoxorubicin treatment. Subjects received either 350 mg/m2 (260 mg/m2 doxorubicin equivalent) (n=6) or 250 mg/m2 (185 mg/m2 doxorubicin equivalent) (n=12) of aldoxorubicin intravenously on Day 1, and every 21 days thereafter until discontinuation. Notably, 2 subjects (11%) diagnosed with tumor progression following aldoxorubicin treatment (1 and 5 cycles, respectively) demonstrated no microscopic evidence of tumor tissue, a pathological complete response, when tissue was examined after resection. Fourteen of 18 subjects discontinued aldoxorubicin treatment, although there is a significant possibility that some of the patients experienced pseudo-progression.Â Pseudo-progression refers to post-treatment imaging changes in the tumor where the tumor appears larger compared to the pre-treatment baseline images. These changes can be misleading in that the tumor appears to get worse (true progression), when in fact the changes may be the result of tumor destruction and related swelling around the tumor bed. Following discontinuation of aldoxorubicin treatment, 10 of 14 subjects received treatment with bevacizumab for 1 to 14 cycles. Deaths have occurred in only 4 of 18 subjects (22%) to date, with survival duration so far of up to 10 plus months. Aldoxorubicin was well tolerated at both dose levels with all adverse events consistent with known doxorubicin toxicities, but not cardiotoxity.Â Grade 3 or 4 adverse events were comprised primarily of neutropenia, anemia and fatigue and occurred mainly in the 350 mg/m2 dose group and were resolved before the next dose. Only two aldoxorubicin-related serious adverse events have occurred in the trial, and both resolved successfully. The primary objective of this Phase 2 trial is to determine progression-free survival (PFS) at 6 months and overall survival (OS) in patients with recurrent glioblastoma multiforme.Â The principal secondary objective is to evaluate the safety of aldoxorubicin in study patients as assessed by the frequency and severity of adverse events. Only patients who have not received prior treatment with bevacizumab are eligible to participate in the trial. The clinical trial is expected to enroll up to 28 patients randomly assigned equally to receive either 350 mg/m2 (260 mg/m2 doxorubicin equivalent) or 250 mg/m2 (185 mg/m2 doxorubicin equivalent) of aldoxorubicin intravenously on Day 1, and every 21 days thereafter until evidence of tumor progression, unacceptable toxicity or withdrawal of consent. Tumor response is monitored every 6 weeks by MRI until disease progression occurs. The trial is being conducted at the John Wayne Cancer Center/Sarcoma Oncology Center in Santa Monica, CA, City of Hope in Duarte, CA, the Louisiana State University Health Sciences Center in New Orleans, LA, and Texas Oncology in Austin, TX. This Phase 2 study follows positive confirmatory results reported in 2013 from a preclinical study in which aldoxorubicin demonstrated statistically significant efficacy (p<0.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals. In that study, animals treated with aldoxorubicin had median survival of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline. In addition, because aldoxorubicin uptake was confined to the tumor in the brain rather than normal brain tissue, the principal investigator concluded that aldoxorubicin has the potential to safely shrink glioblastoma tumors, which could dramatically prolong patient survival.
CytRx Corporation Announces Interim Analysis from its Two Ongoing Phase 1b Aldoxorubicin
May 4 15
CytRx Corporation announced an interim analysis from its two ongoing phase 1b aldoxorubicin combination studies pairing aldoxorubicin with either gemcitabine or ifosfamide. Both studies combine standard doses of gemcitabine or ifosfamide with escalating doses of aldoxorubicin. The combinations appear to be well tolerated, and even at the lowest dose level of aldoxorubicin (170 mg/m2), impressive tumor responses have been observed so far in patients with bone cancer (osteosarcoma) and a variety of soft tissue sarcomas. As such, aldoxorubicin has the potential when used in combination with other cancer agents to become an important new weapon against chemotherapy resistant cancers. The first study is an open-label, Phase 1b clinical trial investigating the preliminary safety and activity of ascending doses of aldoxorubicin plus ifosfamide/mesna for the first-line treatment of patients with locally advanced, unresectable, and/or metastatic sarcomas, including bone cancer. Interim results from seven evaluable patients show that the combination of aldoxorubicin plus ifosfamide/mesna was well tolerated. One bone cancer patient achieved a complete tumor response following five treatment cycles. The company expects to complete dose escalation in this trial in the second half of 2015, and to begin adding sarcoma patients at the maximum well-tolerated dose combination. The second trial is an open-label, Phase 1b clinical trial investigating the preliminary safety and activity of ascending doses of aldoxorubicin plus gemcitabine in patients with advanced, unresectable, metastatic solid tumors that have either relapsed or were refractory to treatment following at least one prior chemotherapy or immunotherapy regimen, and for which no standard approved therapy exists. Interim results from seven patients show that the combination of aldoxorubicin plus gemcitabine was well tolerated. Tumor shrinkage was observed in three of seven patients following two treatment cycles. One patient with advanced dedifferentiated chondrosarcoma (cartilage/bone cancer), chronic severe pain and inability to function normally demonstrated meaningful quality of life improvements, including stopping prescription narcotic pain medications and returning to full-time work. The Company expects to complete dose escalation in this trial in the second half of 2015, and to begin adding patients with either relapsed pancreatic or ovarian cancer at the maximum well-tolerated dose combination.
CytRx Corporation Announces Board Changes
May 1 15
CytRx Corporation announced that it has increased the number of directors of the company from five to six and appointed Eric J. Selter as a member of Board of Directors. The board also appointed Mr. Selter as the Chairman of the Audit Committee and as a member of the Compensation Committee of Board. Such positions include Chief Operating Officer since 2000, Senior Vice President since 2006, and Secretary from 2006 to 2011, then again from 2013 to present.
CytRx Corporation Reports Unaudited Financial Results for the First Quarter Ended March 31, 2015
May 1 15
CytRx Corporation reported unaudited financial results for the first quarter ended March 31, 2015. For the quarter, the company’s net loss was $17,524,550, or $0.31 per diluted share, compared with a net gain of $4,664,518, or $0.08 per diluted share, for the quarter ended March 31, 2014. Loss before other loss was $15,693,977 against $10,118,922 a year ago.
CytRx Corporation Reports Earnings Results for the Year Ended December 31, 2014
Mar 17 15
CytRx Corporation reported earnings results for the year ended December 31, 2014. For the year, the company reported licensing revenue of $100,000, compared to $300,000 for the year ended December 31, 2013. Loss before other income for the year ended December 31, 2014 was $49.60 million, compared to a loss before other income of $27.59 million for the year ended December 31, 2013. Interest income for the year ended December 31, 2014 was $305,331, compared to $137,676 for the year ended December 31, 2013.