On April 20, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that three aldoxorubicin clinical trials have been accepted for poster presentations during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held at McCormick Place in Chicago, Illinois, from June, 3-7, 2016 (Press release, CytRx, APR 20, 2016, View Source;p=RssLanding&cat=news&id=2158694 [SID:1234511140]). The three clinical trials to be presented are:
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Title: Phase 2 study of aldoxorubicin in relapsed glioblastoma
Date/Time: June 4, 2016 1:00pm-5:00pm
Poster Session: Central Nervous System Tumors; Abstract 2027
Title: Phase 1b study of aldoxorubicin + gemcitabine in metastatic solid tumors
Date/Time: June 5, 2016 8:00am-11:30am
Poster Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics; Abstract: 2523
Title: Treatment of HIV-associated Kaposi’s sarcoma with aldoxorubicin
Date/Time: June 6, 2016 8:00am-11:30am
Poster Session: Sarcoma; Abstract: 11038
"Presenting the results from these three clinical trials at the ASCO (Free ASCO Whitepaper) Annual Meeting demonstrates the broad potential for aldoxorubicin and should raise awareness among oncologists," said Daniel Levitt, M.D., Ph.D., CytRx’s EVP and Chief Medical Officer. "Based on its unique ability to selectively bind serum albumin and preferentially release drug at the tumor site, aldoxorubicin has now shown clinical anti-cancer activity in several tumor types including our lead indication of advanced soft tissue sarcomas for which we expect top-line data in June from our pivotal Phase 3 trial."
Aldoxorubicin is CytRx’s lead anti-cancer drug candidate in clinical development utilizing its LADRTM (Linker Activated Drug Release) technology. A global, pivotal Phase 3 trial in patients with relapsed or refractory soft tissue sarcomas has fully enrolled and top-line results for the primary endpoint of progression-free survival are expected in June 2016. The trial is being conducted under a Special Protocol Assessment granted by the FDA. In addition, CytRx is conducting a randomized Phase 2b clinical trial in patients with second-line small cell lung cancer comparing aldoxorubicin topotecan. CytRx has completed enrollment of a Phase 2 trial with aldoxorubicin for patients with relapsed glioblastoma and continues to follow patients for survival. CytRx also conducted a Phase 2 trial with low doses of aldoxorubicin in patients with HIV-related Kaposi’s sarcoma. Aldoxorubicin is currently being tested in two Phase 1b trials in combination with other chemotherapies. The first trial is in combination with gemcitabine for metastatic solid tumors, and the second trial is in combination with ifosfamide as a first-line treatment for patients with soft tissue and bone sarcomas.
About Aldoxorubicin
The widely used chemotherapeutic agent 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. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing 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. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.