ImClone Systems Inc. and Alfacell Corp. each reported Phase II dataMonday showing their anti-cancer agents extended survival whencompared to historical controls.
The data were presented at the 32nd American Society of ClinicalOncology (ASCO) Annual Meeting in Philadelphia, which wraps uptoday.
ImClone, of New York, reported data on small cell lung cancer(SCLC) patients treated with BEC-2, an anti-idiotypic monoclonalantibody designed to mimic a glycolipid antigen found on the surfaceof many tumor cells. It is being developed in collaboration withMerck KGaA, of Darmstadt, Germany. The therapeutic vaccine isdesigned to prevent tumors from growing in patients who first weretreated with chemotherapy or surgery.
ImClone President and CEO Samuel Waksal said four of six treatedpatients remain disease free three and a half years after receiving thevaccine. Average median survival for a patient-matched SCLCreference group was 16.2 months. Waksal said the data werestatistically significant at a p=0.005 level.
Waksal said a Phase III study of BEC-2 for SCLC is expected tobegin in 1997. The company is contemplating a trial in which 300chemotherapy-treated patients will be given either vaccine or noadditional treatment. The endpoint will be time to progression.
That pivotal study also will be run in Europe. Merck, which hasmarketing rights to BEC-2 outside North America, will pay 60percent of development costs in the U.S. and Europe.
ImClone also has completed a pilot study of BEC-2 in malignantmelanoma. Waksal said those data did not reach statisticalsignificance but showed a trend toward prolonged survival. Specificdevelopment of BEC-2 in that indication will be made after SCLCplans are finalized.
Alfacell, meanwhile, presented data from 20 malignant mesotheliomapatients who were treated weekly with Onconase, an RNase proteinthat has been used to treat a variety of tumors in more than 350patients. Malignant mesothelioma is a cancer occurring in the liningof the lungs, chest and abdomen often associated with asbestosexposure.
The company said 13 of 20 evaluable patients in the ongoing studydemonstrated objective clinical activity and had a median survivaltime of two years. Of those, three patients achieved partial responsesand 10 demonstrated stabilization of disease. Most malignantmesothelioma patients die within six to 12 months, the company said.
Alfacell, of Bloomfield, N.J., will keep the study open until the startof Phase III trials, which could get under way in six months, said GailFraser, the company's chief financial officer. The company already isin a pivotal study comparing Onconase and tamoxifen to the standardchemotherapy regimen for pancreatic cancer patients.
Fraser said the company will expand studies beyond the initial twoindications once it arranges financing or brings on a marketingpartner.
Separately Alfacell presented in vitro findings showing Onconaseinhibited the cell activator cyclin D3, and induced expression of thecell cycle inhibitor p27KIP1, which resulted in inhibition of tumorcell growth and proliferation.
In other news from ASCO:
* Sugen Inc., of Redwood City, Calif., reported on interim data froma Phase I dose-escalating study of the signal tranduction inhibitor,SU-101. To date, of the 24 patients with refractory brain cancer whocompleted their initial cycle of therapy, 13 have continued intoextended therapy based on stable disease or better. Radiographicimprovement was seen in three patients.
* Immunomedics Inc., of Morris Plains, N.J., reported data frombreast cancer patients being diagnosed with the imaging agent, CEA-Scan. The company already received an approvable letter for theproduct as an imaging agent for colorectal cancer. The diagnostic wasused on 42 patients with inconclusive mammography findings,requiring surgical biopsies. CEA-Scan was able to predict thosebreast lesions that were not cancerous, showing a specificity (truenegative rate) of 92 percent. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.