Results from AMRI's on-going Phase I clinical study of ALB 109564(a) published online

Jun 2 2010

AMRI (NASDAQ: AMRI) announced today that on-going results from its Phase I clinical study on its novel tubulin inhibitor, ALB 109564(a), were published on the website of the American Society of Clinical Oncology (abstract.asco.org/alb). These results indicate that ALB 109564(a) is well tolerated at the doses tested and shows preliminary evidence of clinical activity in disease types not typically treated with approved vinca alkaloids.

“These are encouraging results for this stage in the study”

The published abstract, "Novel tubulin inhibitor ALB 109564(a) in patients with solid tumors: A Phase I trial" (ID: e13119) describes the methodology of the study and results through December 2009. During this period, 28 patients were administered ALB 109564(a) with doses escalating by cohort from 1.2 mg/m² to 12 mg/m². Neither dose limiting toxicities nor serious adverse events specifically attributed to ALB 109564(a) were observed. Adverse events reported to be at least possibly related to the study drug were all non-serious (grade 1 or 2), the most frequently observed being constipation (5 cases).

"These are encouraging results for this stage in the study," said Bruce Dezube, M.D., associate professor of medicine, Harvard Medical School, a principal investigator of the trial. "We are optimistic that continued dose escalation will further establish the safety profile and help define the clinical utility for this promising new agent."

Of 21 patients evaluated for clinical activity through December 2009, 1 patient with alveolar small part sarcoma received over 21 cycles of study drug with continuing stable disease. In addition, 4 other patients had to this point shown stable disease after 2 cycles: one with colon cancer (4 cycles), one with non small cell lung cancer (4 cycles), one with anal cancer (over 7 cycles), and one with pancreatic cancer (over 5 cycles).

"These results are consistent with our beliefs that our agent would be differentiated by its ability to address additional tumor types," said Dr. Bruce Sargent, Ph.D., vice president, discovery research & development. "We are excited to report a stronger result than expected at this stage. Over 30 patients have now received ALB 109564(a) and dose-escalation continues; we are currently treating our eleventh cohort and have seen additional signs of clinical activity. The good tolerability to date means that we now project to enroll approximately 60 patients in the study. We expect to release further results from the study in the fourth quarter of 2010."

AMRI has filed several patent applications to protect the intellectual property associated with this compound, and plans to ultimately seek a licensee to commercialize this technology.