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Biotech / Medical : CLTR COULTER PHARMACEUTICAL -- Ignore unavailable to you. Want to Upgrade?

To: LLCF who wrote (203)	4/5/1999 7:35:00 PM
From: Vector1	Read Replies (1) \| Respond to of 666

David, News to me. From what I understand is that documentation in connection with CLTR's outsourced antibody and radioactive congigate manufacturing caused the delay. The clinical trial portion of the filing is done and gathering dust. V1

To: LLCF who wrote (203)	4/10/1999 11:14:00 PM
From: Bob L	Read Replies (1) \| Respond to of 666

There is some basis for thinking the additional trials mean a delay in the filing. The trials are mentioned in the recent annual report. Maybe everyone has already read this, but for those who didn't pore over the report, here is an extract. Clinical Development of Bexxar Based on the foregoing results of the Phase I/II, Phase II dosimetry validation and Phase III pivotal clinical trials, the Company will rely on three additional clinical trials to support an application to the FDA for the initial marketing approval of Bexxar expected to be filed in 1999; (i) interim data from an ongoing expanded access clinical trial, (ii) interim data from an ongoing Phase II clinical trial to evaluate the extent to which the therapeutic benefit of Bexxar is derived from the combination of the Anti-B1 Antibody and the radioisotope, in comparison to the Anti-B1 Antibody alone; and (iii) to expand the use of Bexxar to other indications and to support the initial BLA, interim data from an ongoing Phase II clinical trial of Bexxar as a first-line treatment for patients with low-grade NHL and intends to conduct additional clinical trials in the future. The Company's collaboration agreement with SB provides for SB to participate in the administration, management and funding of certain current and future clinical trials. Expanded Access Clinical Trial. The Company currently is conducting a multi-center expanded access trial for patients with NHL who have failed prior chemotherapy. The program was established by the Company in response to requests from physicians and patients for continued access to Bexxar during the period prior to potential FDA marketing approval. The trial is expected to include approximately 100 community and academic oncology centers across the United States. Phase II Unlabeled Versus Labeled Antibody Clinical Trial. The Company is conducting a multi-center Phase II clinical trial in 78 patients with relapsed, low-grade and transformed low-grade NHL. Patients are randomized into two groups: one group receives Bexxar pursuant to the proprietary protocol; the other group receives two 485 mg doses of unlabeled Anti-B1 Antibody eight days apart in a treatment regimen that is parallel to Bexxar. The objective of this clinical trial is to assess the incremental clinical activity from radiolabeling the Anti-B1 Antibody as compared to the clinical activity of the unlabeled Anti-B1 Antibody alone. Administration of the unlabeled Anti-B1 Antibody has not been designed for use as a stand-alone therapy, nor has the treatment regimen been optimized for such use. This trial was the subject of an abstract presented at the 1997 American Society of Therapeutic Radiation Oncology meeting in October 1997. The Company's objective is to complete enrollment of patients in this clinical trial in 1999. Phase II First-Line, Stand-Alone Treatment Clinical Trial. The Company currently is conducting a single-center Phase II trial in up to 80 newly diagnosed low-grade NHL patients. An interim analysis of data from the first 32 patients presented at the American Society of Clinical Oncology meeting in May 1998 showed a 100% response rate with 71% achieving a complete response. Additionally, in nine of the patients, no evidence of NHL could be detected at molecular levels using PCR analysis. As of April 1998, 24 patients were in ongoing remission, with the longest duration being 18.5 months. Side effect were generally mild to moderate 12 <PAGE> 13 and self-limited. The Company believes that its Phase II trial of Bexxar for patients newly diagnosed with NHL is the first trial of radioimmunotherapy as a stand alone, first-line treatment for people with cancer. The Company's objective is to complete enrollment of patients in this clinical trial in the first half of 1999.