CytRx Corporation Receives Orphan Drug Designation from FDA for INNO-206

Strategic Insights -

CytRx Corporation, a biotechnology company specializing in oncology, announced that the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) has granted INNO-206 orphan drug designation for the treatment of patients with soft tissue sarcomas. This designation provides CytRx with exclusive rights to market INNO-206 for the treatment of patients with advanced soft tissue sarcomas in the United States for a period of seven years, as well as tax credits related to clinical trial expenses and a possible exemption from the FDA-user fee.

Key Takeaways:

  • CytRx Corporation received orphan drug designation from the FDA for INNO-206 to treat patients with advanced soft tissue sarcomas.
  • INNO-206 is a novel conjugate of doxorubicin, a commonly prescribed chemotherapeutic, designed to improve efficacy and reduce adverse events through controlled release and preferential targeting of tumors.
  • CytRx plans to initiate a Phase 2b clinical trial with INNO-206 in patients with late-stage soft tissue sarcomas in the second half of 2011, following completion of an ongoing open-label Phase 1b clinical trial.
  • The FDA granted INNO-206 orphan drug designation for the treatment of patients with soft tissue sarcomas, which affects fewer than 200,000 individuals in the United States.
  • Patients with advanced soft tissue sarcomas who can no longer be treated with surgery have a poor prognosis, with a progression-free survival of around six to seven months and a median overall survival of approximately 18 months.
  • Combinations of chemotherapy drugs, including ifosfamide and doxorubicin, offer the highest response rates and longest time to progression in these patients, but have not significantly improved survival.

Statistics:

  • The FDA grants orphan product designation to a drug intended to treat a rare disease or condition, generally affecting fewer than 200,000 individuals in the country.
  • INNO-206 is the second FDA-approved drug for soft tissue sarcomas, following doxorubicin.
  • The second half of 2011 marks the planned initiation of Phase 2b clinical trial with INNO-206 in patients with late-stage soft tissue sarcomas.
  • Patients with advanced soft tissue sarcomas have a progression-free survival of around six to seven months and a median overall survival of approximately 18 months.
  • Combinations of chemotherapy drugs, including ifosfamide and doxorubicin, offer response rates and longest time to progression of 25% to 31% and 2.5 to 5 months, respectively.

Sources:

  • CytRx Corporation press release, April 2011.
  • CytRx Corporation website, http://www.cytrx.com.
  • FDA Orphan Drug Act, Section 526 of the Federal Food, Drug, and Cosmetic Act.