Spectral Diagnostics Inc.

Transcription

1 Spectral Diagnostics Inc. ANNUAL AND SPECIAL GENERAL MEETING JUNE 25, 2012

2 CAUTIONARY STATEMENT Certain statements contained in this presentation constitute forward-looking information within the meaning of securities laws. Forward-looking information may relate to our future outlook and anticipated events or results and may include statements regarding our future financial position, business strategy, budgets, litigation, projected costs, capital expenditures, financial results, taxes and plans and objectives. In some cases, forward-looking information can be identified by terms such as may, will, should, expect, plan, anticipate, believe, intend, estimate, predict, potential, continue or other similar expressions concerning matters that are not historical facts. These statements are based on certain factors and assumptions regarding, among other things, expected growth, results of operations, performance, and business prospects and opportunities. While we consider these assumptions to be reasonable based on information currently available to us, they may prove to be incorrect. Forward looking-information is also subject to certain factors, including risks and uncertainties that could cause actual results to differ materially from what we currently expect. These factors include, among other things, the availability of funds and resources to pursue development projects, the successful and timely completion of clinical studies, and the ability to take advantage of business opportunities, the granting of necessary approvals by regulatory authorities, and general economic, market and business conditions. For more exhaustive information on these risks and uncertainties you should refer to our most recently filed Annual Information Form which is available at Forward-looking information contained in this presentation is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time. 2

3 MAIN POINTS In January 2012 we indicated that we would release an update in June when sufficient data was available Our enrolment rate per site is greater than expected as compared to other sepsis trials Our request for more sites was granted by the FDA The theranostics approach has now reinforced our view that we are selecting the right patients for our trial The composite mortality rate is higher than expected, therefore, more evaluable events have occurred than we originally anticipated 3

4 EUPHRATES Design: Blinded, randomized controlled trial of standard care versus PMX cartridge plus standard care Setting: Intensive Care Units in approximately 60 centers US and Canada Population: Approximately 306 evaluable patients with septic shock 4

5 THE EUPHRATES TRIAL Primary Objective: +28-day mortality in subjects with severe sepsis with hypotension including those subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge twice within 24 hours, versus subjects who receive standard medical care alone Clintrials.gov identifier: NCT

6 INCLUSION CRITERIA 1. Age 18 years old 2. Documented or suspected infection with definitive or empiric antibiotics 3. Evidence of at least 1 new onset organ dysfunction that is considered to be related to current sepsis illness: Positive pressure ventilation and intubated (ET tube or trach) Thrombocytopenia (<150,000 or 50% reduction from prior) Acute oliguria (<0.5ml/kg/hr for 6 hours) despite adequate fluid 4. Hypotension requiring vasopressor support: Requirement for at least one of the vasopressors below at the dose shown for at least 2 continuous hours & a maximum of 30h: Norepi 5 mcg/min Dopamine 10 mcg/kg/min Phenylephrine 25 mcg/min Epinehrine 5 mcg/min Vasopressin >0.03 units/min Vasopressin (any dose) in combination with 1 vasopressor listed above 5. The patient must have received intravenous fluid resuscitation of 30mL/kg administered within 24hours of eligibility 6. EAA 0.6 6

7 SAMPLE SIZE BASED ON 28 DAY MORTALITY ENDPOINT Assumptions: A sample size ratio of 1:1 between the two treatment groups Interim analysis to be conducted A significance level of 5% Power (80%) Analysis based on two-sided Fishers exact test Control arm mortality = 35% Mortality improvement = 15% 7

8 THE EUPHRATES TRIAL- SO FAR The assumption that 50% of the patients that would meet EAA >0.6 has been correct The assumption that the composite mortality rate would be 27.5% (35% placebo and 20% treated) has been exceeded and is running closer to 40% The laboratory experience with running the EAA has been positive with few technical issues The blinded aspect of the trial has been successful Using the Toraymyxin column in ICU s in the US has not proven to be a problem The FDA has approved the expansion of the trial to 60 sites including sites in Canada The rate of recruiting at our sites has been good but more sites are needed to meet timelines 8

9 THE EUPHRATES TRIAL Therefore, we have our strategy for completing the trial Why do we currently believe that it will be positive? 9

10 SUMMARY OF CHALLENGES FOR SEPSIS TRIALS Sepsis is a complex disease with many stages Patient care may vary greatly between different hospitals for both the placebo arm as well as the treatment arm The therapeutic intervention may not be efficient or effective Very heterogeneous patient population with different disease process underlying similar clinical presentation 10

11 LANDSCAPE OF SEPSIS TRIALS SINCE OUR TRIAL STARTED The Access Trial, sponsored by Eisai, was completed but failed to meet primary or secondary endpoints in January 2011 The Prowess Shock Trial was completed in October 2011 but failed to meet primary endpoints of a reduction in mortality and resulted in the removal of Xigris from the market, the only drug specific for treatment of septic shock The Oasis Trial, sponsored by Agennix, was halted and then stopped for safety issues in February of

12 MORTALITY OUTCOMES AT 28 DAYS IN TRIALS OF SEVERE SEPSIS MORTALITY Control Treatment Composite EGDT, Rivers, NEJM % 33.30% (41.20%) * statistically significant but single center EUPHAS, JAMA % 32.00% (42.50%) * statistically significant but stopped early (all in shock and on VP) Eli Lilly, Prowess (APC) Phase III 30.80% 24.70% (27.75%) *statistically significant but stopped early (1690/2280 planned) Eritoran (Phase II) 33.00% 26.60% (29.80%) *(high dose) 32.0 (low dose) NS (p=0.08 ) TAK 242 Inhibit Toll-4 (n=242) 24.00% 22.00% (23.00%) Oasis Trial, Eritoran (Phase III) Final 25.00% 27.00% (26.00%) Prowess Shock ( Lilly) Final 24.00% 26.00% (23.00%) Oasis Trial (Agennix) 18.00% 24.00% (21.00%) interim analysis, halted Low Placebo Mortality Results In Negative Trial 12

13 Changing the Sepsis Paradigm Objective: To transform the diagnosis of sepsis from a physiologic syndrome into one or more biochemical disorders John Marshall, J.L. Vincent, K. Reinhardt International Sepsis Forum Biomarker Conference 13

14 THE EUPHRATES TRIAL Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock 14

15 THE EUPHRATES TRIAL Screened* 141 Randomized 54 subjects Screen Fail 87 subjects EAA < 0.60 : 73 EAA 0.60 : 14 Sham perfusion PMX cartridge *Screened = met all clinical criteria for septic shock and signed consent for EAA 15

16 EUPHRATES MORTALITY RATES Randomized patients composite mortality - 38% Patients meeting clinical criteria - 30% (but low EAA values) Overall study mortality, 141 patients - 33% 16

17 RATIONALE FOR CHANGE OF TIMING FOR INTERIM ANALYSIS Strengths of EUPHRATES Trial: Patient Selection Using EAA as entry criteria which enriches the study population to those most likely to benefit from the intervention Stable Composite Mortality Rate Higher than estimated (27.5%); true (40.0%) 17

18 PLANS FOR PMA SUBMISSION All pre-clinical data being accumulated Manufacturing process being upgraded to meet FDA standards New manufacturing plant has been built in Japan in order to meet the expected North American demand 18

19 CORPORATE STATUS We expect to have sufficient cash to get to proposed interim analyses Now listed on the OTC:QX Daily trading volume increased over the past year Have engaged Equicom, Renmark and MSL Schwartz for IR and PR activities 19

20 GUIDANCE We currently expect to know the FDA status of the proposed interim analysis plan by the end of Q3 of this year 40 sites are expected to be enrolling by December, 2012 Dates for the interim analysis are expected to be predictable in Q4 of this year Target trial completion end of 2014, which is subject to certain factors and assumptions, including: Site initiation, site enrolment, and interim analysis dates We expect to have sufficient cash through to interim analysis Partnering opportunities may increase with interim data 20