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  • CytRx, Inc. (CYTR) Reports Statistically Significant Results From Aldoxorubicin Phase 2b 0 comments
    Dec 11, 2013 3:03 PM | about stocks: CYTR

    CytRx, an biopharmaceutical innovator of oncology treatments, today announced extremely promising results in the global Phase 2b clinical trial of aldoxorubicin, the company's chemotherapeutic drug, as a first-line treatment for advanced soft tissue sarcomas (NYSEMKT:STS) versus the widely used chemotherapeutic agent doxorubicin. In premarket trading, the stock traded at a 65% premium to yesterday's close on over $12.4+ million dollar volume.

    The trial consisted of a multicenter, randomized, open-label clinical study. In this 123-subject, 31-center global Phase 2b clinical trial, subjects with advanced soft tissue sarcomas were administered either 350 mg/m2 of aldoxorubicin (83 subjects) or 75 mg/m2 of doxorubicin (40 subjects) every 3 weeks for up to 6 cycles. Subjects were followed every 6 weeks with CT scans to monitor tumor size. The primary endpoint was progression-free survival (NYSE:PFS) as determined by both investigators at study sites and by a blinded radiology review performed at an independent central laboratory. Secondary endpoints included overall response rates (complete and partial) and PFS at 6 months for each group, and overall survival, which will be reported when the clinical trial is complete.

    Consistent with the trial protocol, CytRx used two approaches to evaluate the efficacy of aldoxorubicin compared to doxorubicin in patients with soft tissue sarcomas: assessment by the study investigators, as well as assessment by a blinded central laboratory review.

    As determined by both the trial investigators and by blinded central radiology review, subjects treated with aldoxorubicin demonstrated highly statistically significant better clinical outcomes than those receiving standard doxorubicin therapy for their soft tissue sarcomas. In the Phase 2b clinical trial aldoxorubicin was found to be safe and well tolerated. All adverse events in subjects treated with aldoxorubicin were consistent with the known side effects of doxorubicin, resolved before the administration of the next dose and did not require treatment discontinuation. There were no treatment-related deaths in the aldoxorubicin group.

    "These results are extraordinary for a single agent treating these chemotherapy-resistant tumors," said study principal investigator Sant Chawla, M.D. of the Sarcoma Oncology Center in Santa Monica, California. "Aldoxorubicin is the first and only single agent to surpass doxorubicin as a first-line treatment for soft tissue sarcomas."

    Dr. Chawla added, "Previous results from this trial presented at the Connective Tissue Oncology Meeting in October indicated that subjects treated with aldoxorubicin demonstrated no significant cardiotoxicity whereas doxorubicin shows cardiotoxicity at certain cumulative dose levels. No subjects left the study due to aldoxorubicin side effects. These findings together suggest that aldoxorubicin could become the treatment of choice for soft tissue sarcomas. Yet this drug's potential extends much further because doxorubicin in particular and anthracyclines in general are indicated as first- or second-line therapy for many other common cancers including breast, ovarian, small-cell lung, multiple myeloma, acute myelocytic leukemia and more. As such, the ability of aldoxorubicin to safely administer high doses of doxorubicin holds tremendous therapeutic potential to oncologists and their patients worldwide."

    CytRx President and CEO Steven A. Kriegsman commented, "Aldoxorubicin is a major advance for treating soft tissue sarcomas. We extend gratitude to the investigators who so adeptly managed the conduct of this trial and to the patients and their families who participated in it. These data prove that by applying our proprietary linker technology to target the release of doxorubicin directly at the site of cancer we are able to safely increase the dosage of doxorubicin by approximately three and one-half to four times with tremendous clinical benefit to the patient."

    For more information, visit: cytrx.com

    MissionIR provides investor relations services to publicly traded companies in exchange for compensation. This article may be part of our efforts to widen a client's exposure. To read our full disclaimer, visit http://disclaimer.missionir.com

    Stocks: CYTR
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