San Francisco Bay Area Chapter of the American Statistical Association Meeting

Title:	RRx-001: Resensitization to Irinotecan Hypothesis in Refractory CRC Subjects with ≥2 Prior Failures Stochastic Model Strategy & Analysis
Presenter:	Dr. Nacer Abrouk PhD, Department of Biostatistics, Innovexe Inc. Palo Alto, California
Time:	April 27th, 4:30 - 6pm (4:30-5pm networking, 5-6pm presentation with Q&A)
Location:	M106 at the School of Medicine courtyard at Stanford: 291 Campus Drive, Medical Center, Alway building, ground floor, on the Dean's courtyard. Parking is free after 4 pm and there should be more available space at that time. Map

Abstract

RRx-001, a novel oxidizing and epigenetic agent, has shown promise as a single agent in a Phase I trial and is currently in Phase II trials, both alone and in combination with immunotherapy (Nivolumab), chemotherapy and radiation therapy. These results demonstrate that inhibition of the

PD-1/PD-L1 axis in combination with RRx-001 can significantly increase the CR rate in a preclinical model of myeloma. Experiments are ongoing to optimize this treatment regimen, study the effects of the combined treatment on the tumor immune microenvironment, and the study of the efficacy of this combined therapy in other tumor types. Results from this ongoing work will be presented, and have near-term translational potential.

Current clinical data from a Phase 2 study in Colorectal Cancer (CRC) will be used to demonstrate the use of stochastic modeling in testing the resensitization hypothesis. The following items will be discussed:

1. CRC stochastic models.

2. Statistical analysis of clinical CRC data.

3. Illustration of challenges & potential solutions.

4. Translational potential conclusion, discussion & future work directions.

Bio for Dr. Nacer Abrouk:

Founder & CEO of Innovexe LLC, a silicon valley bio-informatics company specializing in bio-pharmaceutical drug development. Study to Evaluate the Efficacy and Safety of TI-001 (intranasal oxytocin) at Three Dose Levels for the Preventive Treatment of Chronic Migraine.

Executive professional with extensive hands-on experience in bio-pharmaceutical R&D. Regulatory (FDA/EMA/Health Canada) filing in pain, gastroenterology, oncology, diabetes, cardiovascular, anemia, anti-infective, medical devices.

Most recent NDA filing & approval (October 2014, AstraZeneca: Movantik, opioid-induced constipation). Study # TRIG-P203

Served on corporate executive committees, contributed to regulatory & business development strategies. Significant experience in joint Phase 2 development programs and partnership strategic arrangements. Specifically, AstraZeneca, Baxter, Pfizer, Alpharma, King Pharm, J&J, Pain Therap.

Academic experience includes a tenured Associate Professorship of Statistics, Rose-Hulman Institute of Tech. Investigational Product TI-001 Active Ingredient Oxytocin Sponsor EpicentRx Inc.

Previously-held corporate positions include VP of Biometrics, Nektar Therap, VP of Biometrics, Durect Corp, Director, J&J, Amgen, Pfizer/Parke-Davis/Warner-Lambert, Tenured Assoc. Professor of Statistics, Rose-Hulman Institute of Tech.

Successful submissions & marketed drugs: Movantik, Duragesic, Jurnista, Ionysys, Priligy, Aranesp, Neulasta, , Rezulin.