CytRx Reports Completed Phase 1b/2 Progression-Free Survival and Overall Survival Aldoxorubicin Data in Second-Line Soft Tissue Sarcoma

On May 5, 2014 CytRx reported updated progression-free survival (PFS) and overall survival (OS) results from its completed Phase 1b/2 clinical trial (NCT01514188) of aldoxorubicin in patients with advanced soft tissue sarcoma (STS) (Press release CytRx, MAY 5, 2014, View Source;p=RssLanding&cat=news&id=1925718 [SID:1234500486]).
Data from the Phase 1b/2 trial demonstrated that aldoxorubicin administered at its maximum tolerated dose (350mg/m2) showed a substantial increase in median PFS in patients with advanced soft tissue sarcoma (n=13). Partial responses were observed in 5 of 13 patients (38%) and stable disease was observed in 6 of 13 patients (46%). Median PFS of 6.4 months was initially reported at ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper); in the final reported data, observed median PFS had nearly doubled to 11 months, and median OS was 17 months. Notably, following 8 cycles of aldoxorubicin, two patients experienced no progression of disease for 23 and 15 months, respectively, despite no further treatment. Aldoxorubicin was generally well tolerated with no observed cardiotoxicities and no drug-related deaths.

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Aldoxorubicin is currently being studied in a pivotal global Phase 3 clinical trial evaluating the efficacy and safety of aldoxorubicin as a second-line treatment for patients with STS under a Special Protocol Assessment with the FDA. CytRx is also conducting two Phase 2 clinical trials evaluating aldoxorubicin in patients with late-stage glioblastoma (GBM) and HIV-related Kaposi’s sarcoma.

New Japanese Patents Issued Covering Sapacitabine Pharmaceutical Formulations and Combination Treatments

On May 5, 2014 Cyclacel Pharmaceuticals reported that the Japanese Patent and Trademark Office issued two patents broadening the exclusivity of sapacitabine, the company’s lead clinical candidate (Press release Cyclacel, MAY 5, 2014, View Source [SID:1234500485]). Japanese Patent 5443763 claims novel pharmaceutical formulations of sapacitabine. Japanese Patent 5457196 claims methods of treating cancer comprising sapacitabine in combination with histone deacetylase (HDAC) inhibitors. Equivalent patents have been granted in the United States and other countries.

Advaxis to Initiate Clinical Development of ADXS-cHER2 Immunotherapy to Treat Pediatric Bone Cancer

On May 5, 2014 Advaxis reported that it intends to initiate a clinical development program with its product candidate, ADXS-cHER2, for the treatment of pediatric osteosarcoma (Press release Advaxis, MAY 5, 2014, View Source [SID:1234500483]). ADXS-cHER2 is an immunotherapy that targets the HER2 oncogene, which is overexpressed in certain solid-tumor cancers, including pediatric bone cancer and breast cancer. In a veterinarian clinical study, pet dogs with naturally occurring osteosarcoma treated with ADXS-cHER2 after the standard of care showed a statistically significant prolonged overall survival benefit compared with dogs that received standard of care without ADXS-cHER2. Both veterinary and human osteosarcoma specialists consider canine osteosarcoma to be the best model for human osteosarcoma.

(Press release, Dual Therapeutics, MAY 2, 2014, View Source [SID:1234503291])

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Advaxis Receives Orphan Drug Designation for Treatment of Invasive Cervical Cancer

On May 1, 2014 Advaxis reported that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead immunotherapy drug candidate, for the treatment of Stage II-IV invasive cervical cancer (Press release Advaxis, MAY 1, 2014, View Source [SID:1234500482]).