By Brady Huggett
BioTransplant Inc. merger partner, Eligix Inc., received clearance from the FDA to initiate a pivotal Phase III trial for its BCell-HDM Cell Separation System.
The trial is designed to serve as a basis for a premarket approval application, will involve 12 cancer centers in the United States, and is constructed to demonstrate elimination of potentially malignant B cells from autologous stem cell transplants for patients with low-or intermediate-grade non-Hodgkin¿s lymphoma.
¿It really is a do-no-harm in reconstitution endpoint,¿ said Elliot Lebowitz, president and CEO of BioTransplant. ¿The concept is that you will benefit the patients by removing the cancer cells from the autologous bone marrow you give back to the patients. The FDA is looking to see that you are not doing any harm by using the device.¿
The secondary endpoint, Lebowitz said, is checking that malignant B cells are actually depleted from the transplant.
Lebowitz was hesitant to put a firm time line on accrual or the trial¿s length, but said in the best case scenario, enrollment will take a year and there will be a year of follow up with patients.
BioTransplant, of Charlestown, Mass., received European Union authorization to affix the CE Mark to its BCell-HDM cell separation devices for the treatment of B cell malignancies in February. The $55 million merger with privately held Eligix, of Medford, Mass., announced in December, allows BioTransplant to market the first of several planned Eligix Cell Separation products in the European community. (See BioWorld Today, Dec. 12, 2000.)
Lebowitz said he expects the merger to close soon, and the strategy behind it has been fruitful so far.
¿The concept of the merger was to strengthen the product portfolio that BioTransplant currently has,¿ he told BioWorld Today. ¿And to have a product line that will have sales in Europe this year, and a Phase III trial in the United States.¿
BioTransplant¿s stock (NASDAQ:BTRN) rose 91 cents Monday, or about 17 percent, to close at $6.05.