By Grant Zeng, CFA
In early December 2016, Critical Outcome Technologies (TSX:COT.V) (OTC:COTQF) appointed Alison Silva as the Company’s new Chief Executive Officer (CEO) effective January 1, 2017. Ms. Silva served before the appointment on the Board of Directors and as President.
Alison has worked with COT.V in various roles since 2013, during which time she has been integral in shaping the Company’s orphan drug development strategy. Ms. Silva joined COTI’s Board of Directors and management team in May 2015 and has been the Company’s President since July 2016. Prior to joining COT.V, she was Co-founder, Executive Vice President and Chief Operating Officer of Synlogic, a company focused on the discovery and development of programmed therapeutic probiotics. Alison is also Co-founder of The Orphan Group, a specialty consulting company that helps companies develop and implement orphan drug strategies and manage their product lifecycles.
Alison has a diverse 16-year background in biotech with a career of rising responsibility. Specifically, Ms. Silva’s expertise spans U.S. corporate and clinical operations as COO of SLA Pharma; Drug and Business Development as VP at Marina Biotech and Cequent Pharmaceuticals; and various positions at Pfizer, Massachusetts General Hospital, and the University of Massachusetts. Alison holds a Bachelor’s degree from Clark University and a Master’s degree from Clark University and UMass Medical Center.
We welcome the appointment of Alison Silva as the new CEO of the company. We believe the new CEO, with such a diverse background in the biotech industry, will lead the company to a new level. More specifically, we believe the appointment will accelerate the clinical development of the company’s lead compound COTI-2 and lead to a rapid expansion in the US.
Phase I Study of COTI-2 Advances to Fourth Cohort
At the end of 2015, COT.V, together with its collaborator MD Anderson, initiated a Phase I clinical trial to evaluate COTI-2 for the treatment of patients with gynecological cancers including ovarian cancer, fallopian tube cancer, endometrial cancer, cervical cancer, and peritoneal cancer (NCT02433626).
This Phase I trial is a single arm, single center, open-label study of COTI-2 in female patients with platinum-resistant, recurrent ovarian (including fallopian tube or primary peritoneal cancer), endometrial, or cervical cancer. COTI-2 will be self-administered as a single agent, orally, once daily for 5 days followed by 2 treatment-free days each week. 1 cycle will be defined as 4 weeks of treatment as described (5 days on, 2 days off per week). Participants will remain on treatment until they experience a lack of benefit.
The primary endpoints will be safety and tolerability. Secondary endpoints include clinical response and progression free survival (PFS). The trial will enroll up to 46 patients.
Treatment of the first cohort commenced on February 15, 2016.
The company commenced treating patients in the second cohort on April 18, 2016. Treatment of the second cohort will continue to evaluate COTI‐2’s safety profile at a dosage level twice that of the first cohort. Prior to initiating cohort two, the independent Dose Escalation Committee reviewed the safety data from all patients in the first cohort and unanimously approved moving to dosing the next cohort.
On June 3, 2016, the company activated a second treatment site at the Lurie Cancer Center at Northwestern University in Chicago, Illinois. This will broaden the base of patients who can potentially qualify for the study with the goal of expediting the enrollment of patients into the trial and thus allowing the overall trial to move forward on a timelier basis.
On July 12, 2016, COT.V commenced dosing women in the third cohort of the Phase I clinical trial of COTI‐2 intended for the treatment of gynecological cancers. There were no significant adverse events attributed to treatment in any of the cohort 3 patients. Accordingly, the independent Dose Escalation Committee granted a favorable opinion to move ahead with the fourth cohort of patients.
On Jan 10, 2017, COT.V announced that the Company has commenced dosing women in the fourth cohort of the ongoing Phase I clinical trial of COTI‐2. The first two patients in cohort 4 have begun receiving COTI‐2 at a dosage level of 1.7 mg/kg, an increase from the 1.0 mg/kg level of cohort 3. The objective of the fourth cohort is to continue to evaluate the safety and tolerability of COTI‐2.
We expect top line data to be available in mid-2017.
COT.V is also planning clinical trials in Canada and the US for the treatment of patients with recurrent head and neck squamous cell cancer. The Company will file an Investigational New Drug application with the US FDA and is also completing a Clinical Trial Application for submission to Health Canada.
The next step with COTI-2 will be the initiation of a Phase II trial for ovarian cancer in 2017 following the conclusion of the Phase I trial. The logic of choosing ovarian cancer is because as many as 95% of ovarian cancer patients have a p53 gene mutation, and the market for ovarian cancer treatment in the US will well surpass $1 billion.
COTI-2 received an orphan-drug designation for ovarian cancer by the FDA in June 2014.
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