MOGN....Emperor...clothes...none...?
Single patient responses? Neutropenia?
Sorry, I miss the point where I should get all excited. I recall the old TNF days were not too dissimilar. I don't have any MOGN, NOT short either. Be interested what Peter sees in it.
From Russian Bear over on MOGN thread from their Feb 9 PR:
"With 49 patients already enrolled, full enrollment is imminent in MGI PHARMA's 50 patient Phase 2 clinical study to test the safety and efficacy of irofulven in the treatment of pancreatic cancer patients who have failed gemcitabine (Gemzar©) therapy. The primary clinical endpoint for this study is six-month survival, with secondary endpoints for objective tumor shrinkage, time to tumor progression and quality of life measures.
With many patients only recently enrolled, it is premature to speculate on overall response rates. However, the company is encouraged that objective responses have been observed in this Phase 2 study, similar to the partial response previously reported for a (NOTE "a" as in 1-RWR)pancreatic cancer patient in the initial Phase 1 study. Bone marrow suppression is the primary dose-limiting side effect in this patient group. Interim data from all three MGI PHARMA sponsored Phase 2 cancer studies have been submitted for presentation during the annual American Society of Clinical Oncology meeting being held May 20-23, 2000 in New Orleans.
In addition to the pancreatic cancer study, irofulven is in clinical trials in other types of cancer, including the following:
Ovarian cancer studies. Both MGI PHARMA and the National Cancer Institute are conducting Phase 2 ovarian cancer studies in patients who have failed prior therapies. Investigators have observed objective partial responses (defined as tumor size reduction of 50% or more) in both studies. Interim data from the NCI study has been submitted for presentation during the annual American Association for Cancer Research meeting being held April 1-5, 2000 in San Francisco.
Drug Combination Study. In the Phase 1 study combining irofulven and irinotecan (Camptosar©) therapy in cancer patients, a 47% reduction in tumor size was previously reported for a (Note another "a" as in 1-RWR) non-small cell lung cancer patient. The patient's response has improved to a 70% reduction in tumor size, with treatment continuing after eight cycles of treatment. This objective partial response provides clinical evidence (Gah! Biostatisticians will be spinning in their graves at 3000RPM!-RWR) that irofulven can be effectively combined with a topoisomerase I inhibitor. Reversible neutropenia has been the most significant side effect observed to date in this dose escalating study. Animal studies have previously shown significant synergistic antitumor activity with irofulven and irinotecan (Camptosar©) in human colon tumor xenografts (Cancer Research 59:1049-1053, 1999) and with topotecan (Hycamtin©) in human myeloid leukemia tumor xenografts (Leukemia 14:136-141, 2000). ( I think we already know about xenograft studies, which is why NERX is $19 and not $70-RWR)
NCI studies. The NCI has initiated eleven Phase 2 studies in eight different types of cancer with irofulven. Several studies have been closed to further enrollment because the efficacy requirements for trial expansion were not met in the first groups of patients.
``We have now confirmed clear objective evidence of irofulven's antitumor activity as monotherapy in Phase 2 studies in a variety of solid tumors, including prostate, pancreatic and ovarian. We look forward to reporting interim results from these trials at the upcoming cancer meetings,' observed Dr. John R. MacDonald, MGI PHARMA's vice president of research and development. ``Further, based on results from our Phase 2 studies, plus the NCI studies, around mid-2000 we expect to define our registration strategy for the next stage of irofulven's development.'
Irofulven (also designated MGI 114) is the lead drug in MGI PHARMA's acylfulvene family of proprietary anti-cancer compounds. It is a new chemical entity with a novel mechanism of action against cancer cells."
That's it. Voodoo stats and not much of a pipeline. Better bets out there to be had.
RWR |
