Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Last week, CytRx Corporation (CYTR) announced encouraging data on its oncology candidate, aldoxorubicin, from a phase IIb study. The randomized, open-label phase IIb study compared the use of aldoxorubicin to doxorubicin in patients suffering from advanced soft tissue sarcomas. Doxorubicin is the current standard-of-care for this indication.
The study met its primary endpoint with aldoxorubicin increasing median progression-free survival by approximately 104% to 5.7 months, as compared to 2.8 months with doxorubicin. Additionally, patients in the aldoxorubicin arm showed 41% likelihood of surviving more than 2 years as compared to a 20% probability for patients in the doxorubicin arm. Aldoxorubicin also demonstrated a 27% reduction in the risk of death.
CytRx has already initiated a pivotal phase III study on aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy under the FDA’s special protocol assessment. The company intends to complete the enrollment process by the end of 2015. We note that earlier last week, the FDA lifted the partial clinical hold on aldoxorubicin allowing the company to enroll and dose new patients on aldoxorubicin (read more: CytRx Relieved as FDA Lifts Partial Hold on Oncology Drug). Data from the study should mature by mid-2016. If successfully developed and eventually approved, CytRx plans to launch aldoxorubicin for second-line soft tissue sarcoma in 2017.
We note that several companies including Johnson & Johnson (JNJ) are developing drugs targeting these indications.
Apart from soft tissue sarcoma, CytRx is also evaluating aldoxorubicin for several other indications including glioblastoma (phase II), Kaposi's sarcoma (phase II) and small cell lung cancer (phase IIb). The company is also evaluating aldoxorubicin in combination with Eli Lilly and Company’s (LLY) Gemzar (gemcitabine) and Bristol-Myers Squibb Company’s (BMY) Ifex (ifosfamide). We expect investor focus to remain on further updates on the pipeline.
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