Cellectar Biosciences Inc (NASDAQ:CLRB) announces the initiation of a Phase II clinical study of its lead phospholipid drug conjugate (PDC) CLR 131 in patients with multiple myeloma and other hematologic malignancies.
The study will be conducted in up to 15 centers in the United States for patients with a variety of orphan-designated relapse or refractory hematologic cancers. The study’s primary endpoint is objective response rate (ORR), with additional endpoints of progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a single 25.0 mCi/m2 dose of CLR 131, with the option for a second 25.0 mCi/m2 dose approximately 75-180 days later. Cellectar will receive approximately $2 million in a non-dilutive grant to help fund the trial from the National Cancer Institute and initial efficacy data are expected as early as the second half of 2017.
“I would like to thank the entire team at Cellectar whose diligent efforts enabled the company to initiate the Phase II trial a full quarter ahead of our original guidance. The prospect of extending patient survival with a one or two-dose treatment continues to drive a high sense of urgency for all involved in this study as we continue to focus on providing clinical benefit to patients who suffer from these difficult to treat conditions,” said Jim Caruso, president and CEO of Cellectar Biosciences. “Given the results from our Phase I trial of CLR 131 in multiple myeloma, we are enthusiastic about the potential outcomes of this Phase II trial, and look forward to reporting results as they become available.”
The hematologic cancers to be studied include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL).
In addition to the CLR 131 infusion(s), MM patients will receive 40 mg oral dexamethasone weekly for up to 12 weeks. Efficacy responses will be determined by the latest International Multiple Myeloma Working Group criteria. Efficacy for all lymphoma patients will be determined according to Lugano criteria.
Shares of Cellectar Biosciences closed yesterday at $2.30, up $0.02 or 0.88%. CLRB has a 1-year high of $5.05 and a 1-year low of $1. The stock’s 50-day moving average is $2.35 and its 200-day moving average is $1.98.
On the ratings front, Ladenburg Thalmann analyst Wangzhi Li initiated coverage with a Buy rating on CLRB and a price target of $2.70, in a report issued on December 21. The current price target represents a potential upside of 17% from where the stock is currently trading. According to TipRanks.com, Li has a yearly average return of 7.2%, a 40% success rate, and is ranked #2446 out of 4555 analysts.
Cellectar BioSciences, Inc. operates as a biopharmaceutical company. It engages developing phospholipid drug conjugates designed to provide cancer targeted delivery of oncologic payloads to cancer stem cells.