What did happen charlie? Some of this I have to thank other posters for.
July 23, 1998
Techniclone Corporation (NASDAQ:TCLN) announced today that the Food and Drug Administration has allowed an amendment to the current Phase II/III Oncolym(R) clinical trial protocol to include patients that have failed or relapsed following treatment with other monoclonal antibodies for non-Hodgkin's Lymphoma.
2002
"We are pleased with the interest that researchers continue to show in working with our Lym-1 antibody in B-cell lymphoma," said Edward J. Legere, Peregrine's president and CEO. "We are actively pursuing potential licensing and development partners for the Oncolym (Lym-1) technology to advance clinical and commercial development. We believe Oncolym can be competitive in the B-cell lymphoma market place."
Oncolym is the trade name for the radioimmunoconjugate formed when the Lym-1 monoclonal antibody is attached to iodine-131, a radioactive form of iodine. To date, 126 patients were exposed to Oncolym in seven IND protocols. 114 patients have been treated with a therapeutic dose of Oncolym. In these trials, patients have achieved meaningful complete remissions ("CR") where there is no detectable tumor and partial remissions ("PR") where at least there is a 50% shrinkage of the tumor mass. An overall response rate (complete and partial responses) of 33.7% has been demonstrated in patients with aggressive Non-Hodgkin's Lymphoma. Radiation dosimetry demonstrates a tolerable safety index. Minor side effects such as thrombocytopenia (low platelet count) and leukopenia (low white blood cell count) have been observed. Clinical studies have revealed that the side effects appear to be reversible, manageable and to resolve without complications. To date, the 25 patients with an indolent form of NHL have been treated, of which 14 responders (56% response rate) with five CRs and nine PRs. In addition, 89 patients with an aggressive form NHL were treated, of which, there were 30 responders (33% response rate) with nine CRs and 21 PRs. Some patients treated with Oncolym have experienced durable complete remissions, the longest being about ten years.
Results: Lym-1 and rituximab showed significant direct and indirect antilymphoma effects. Lym-1 had a substantial, and statistically greater, effect than rituximab over longer intervals of time. In Raji and B35M cells, Lym-1 induced potent growth inhibition reflected by 90% and 94% reductions in viable cells, respectively, whereas rituximab induced 63% and 56% reductions. Concurrently, Lym-1 increased nonviable cells by 372% and 153% in these cells, respectively, whereas rituximab induced 139% and 43% increases. Lym-1-induced apoptosis was greater than that of rituximab in all cell lines tested. Lym-1, both the chimeric form and the mouse parent, mediate ADCC more effectively, in the presence of a total peripheral blood leukocyte (PBL) population, than does rituximab, although the results for CDC activity were mixed. Conclusions: In conclusion, Lym-1 had more potent direct and indirect cytotoxic effects than rituximab in lymphoma cells under conditions achievable in patients. Because the HLA-DR target antigen of Lym-1 is enriched on most B-cell lymphomas, these results support its complementary use in patients as an alternative to CD20 for monoimmunotherapy and for combination immunotherapy with rituximab, because the HLA-DR and CD20 antigens are physically and functionally coupled on human B cells.
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