Infinity Pharmaceuticals to report IPI-145 pro... - CLL Support

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Infinity Pharmaceuticals to report IPI-145 progress at ASCO 2013


Infinity Pharmaceuticals are reporting phase I trial results on how their PI3K oral inhibitor performed on people with relapsed or refractory CLL or SLL at the American Society of Clinical Oncology's 2013 meeting, which commences on 31st May in Chicago.

From the Wall Street Journal report of first quarter 2013 financial results and company update:

"Infinity today announced that an investigator-sponsored Phase 1b, open-label, dose-escalation study of IPI-145 in approximately 70 people with B-cell NHL, CLL and T-cell lymphoma is open for enrollment. The study is designed to evaluate the safety, pharmacokinetics and clinical activity of IPI-145 in combination with rituxan (a monoclonal antibody therapy), bendamustine (a chemotherapy) or both rituxan and bendamustine"

"Infinity also announced that IPI-145 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL."

"Infinity is also evaluating IPI-145 in inflammatory indications and has made important progress advancing studies of IPI-145 in rheumatoid arthritis and asthma."

I expect this is where they hope to profit from IPI-145. If they are successful in this and IPI-145 CLL trials prove successful, then this could be another drug in the CLL treatment arsenal.

Some company background from Oncology Business Review from February this year comparing Infinity with Pharmalytics (Ibrutinib):

"The company presented ASH 2012 showing suggestive data that IPI-145 has a therapeutic profile that is similar to both ibrutinib and idelalasib, with activity shown in CLL/SLL, mantle cell lymphoma, indolent non-Hodgkin lymphoma, and, unlike the other two agents, PTCL (a potential differentiating factor for the compound)."

Be interesting to see if the early promise is borne out by what is presented at ASCO. Now if only the extra competition brought down the prices...


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Here's a report of what Infinity presented to ASCO:

"The early data from this Phase 1 study of IPI-145 continue to be encouraging. IPI-145 was well tolerated and showed rapid clinical activity in patients with CLL, with a median time to response of 1.9 months," commented Ian Flinn, M.D., Ph.D., director, hematologic malignancies program, Sarah Cannon Research Institute.

"Data presented today showed that IPI-145 was well tolerated, with a safety profile consistent with co-morbidities seen in patients with advanced hematologic malignancies. There have been no dose-related trends in adverse events at the doses evaluated from 8 mg BID to 75 mg BID in either the total safety population or in patients with CLL."

"IPI-145 is clinically active in patients with CLL, with a rapid onset of response as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) IWC criteria(2) and a rapid resolution of lymphocytosis. Among the 22 patients evaluable for response, there were 12 partial responses (55 percent IWCLL partial response rate) and an additional seven nodal responses. The median time to response was 1.9 months (range:1.8 - 5.6 months). Ten of the 12 partial responses were at doses less-than or equal to 25 mg BID."

"Among four patients evaluable with 17p del, there were two partial responses, one stable disease, and one progression due to Richter's transformation. Among six patients evaluable with a p53 mutation, there were four partial responses and two nodal responses."

" Infinity also today announced that it has initiated a new expansion cohort within its ongoing Phase 1 study to evaluate the safety, activity and pharmacokinetics (PK) of IPI-145 dosed at 25 mg twice daily (BID) as treatment for patients with newly diagnosed, high-risk CLL."


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