Cell Therapeutics Inc. (CTIC) received a boost with the European Medicines Agency (EMEA) validating the expanded Pediatric Investigation Plan (PIP) filed by the company in July this year for its lead candidate pixantrone. The candidate is being developed for the treatment of relapsed or refractory, aggressive non-Hodgkin’s lymphoma (NHL) in patients who have not responded to other treatment options. The PIP provides the outline of the process the company intends to follow to study the drug in children.
The validation of the PIP is an important step toward the submission of a Marketing Authorization Application (MAA) and the subsequent approval for pixantrone. Following the validation, the Pediatric Committee (PDCO) of the EMEA will scrutinize the PIP and comment on or approve the content of the plan. The approval of the PIP will enable the company to submit the MAA for its lead candidate in Europe later in the year. The pediatric program intends to evaluate the safety and efficacy of pixantrone compared to chemotherapy drug doxorubicin in children (aged between 6 months and 18 years).
We remind investors that Cell Therapeutics submitted the updated, expanded PIP in July this year following the recommendation of the PDCO to expand the original PIP, which was submitted in September 2009. The pediatric body asked Cell Therapeutics to include the candidate’s potential but unconfirmed benefit to children in reducing the long-term cardiotoxicity (side-effect) associated with current medications. The recommendation, made in April this year, followed discussions regarding the data pertaining to pixantrone and the desire to explore the potential benefits of pixantrone in children suffering from hematologic cancer.
Earlier in the year, pixantrone was denied approval by the US Food and Drug Administration (FDA) due to lack of sufficient clinical data. Following the denial, the company submitted a proposal for a new study for the candidate in aggressive NHL to the US agency earlier in the month.
Cell Therapeutics is a Zacks #3 Rank (Hold) company, which indicates that the stock is expected to perform in line with the overall US equity market for the next 1–3 months. Our long-term Neutral stance on the company indicates that the stock is expected to replicate its short-term performance, but over 6+ months. Consequently, we advise investors to retain the stock for the period.
The lack of estimate revisions by the analysts covering Cell Therapeutics implies a lack of directional pressure on the stock. This further supports our short-term and long-term stance on the stock.