Early and accurate diagnosis of cancer, moving towards a solution. Highly sensitive serum-based cancer diagnostics; a solution in the developing world Kiarash Moshiri BSc. MED ST Abstract code: SAT.1.395-2 Disclosure of Interest: None Declared www.worldcancercongress.org
Safe Harbour Statement Statements in this presenta-on that are not strictly historical are forward- looking and involve a some degree of risk and uncertainty. These include, but are not limited to, statements related to Panacea s technology and product candidates (including Panacea s ability to iden-fy, develop and commercialize new products and product candidates, either independently or with collabora-on partners, and Panacea s -metable for doing so), lines of business, markets (including market size and Panacea s ability to iden-fy, develop and commercialize products to address those markets), opera-ons (including Panacea s ability to successfully nego-ate and enter into collabora-on partnerships), capabili-es, commercializa-on ac-vi-es, customer adop-on rates, industry condi-ons, future financial performance, and near- term and longer- term growth and prospects. Such statements are only predic-ons, and actual events or results may differ materially from those projected in such forward- looking statements. Factors that could cause or contribute to the differences include, but are not limited to, risks associated with Panacea s strategic focus, technologies and products (including Panacea s ability to iden-fy, develop and commercialize new products, either independently or with collabora-on partners, and market demand for these product and product candidates), dependence on patents and proprietary rights, protec-on and enforcement of its patents and proprietary rights, the commercial prospects of the industries in which Panacea operates and sells products, Panacea s dependence on manufacturing and/or license agreements, its ability to achieve milestones under exis-ng and future collabora-on agreements, the ability of Panacea s and its partners to commercialize its products (including by obtaining any required regulatory approvals) using Panacea s technologies, the -ming for launching any commercial products and projects, the ability of Panacea s and its collaborators to market and sell any products that it or they commercialize, the development or availability of compe--ve products or technologies, the future ability of Panacea to enter into and/or maintain collabora-on and joint venture agreements and licenses on a -mely basis or at all. These forward- looking statements speak only as of the date hereof, and Panacea expressly disclaims any intent or obliga-on to update these forward- looking statements. PRIVATE & CONFIDENTIAL
Contact Information Kiarash Moshiri 330 Highway #7 East, Suites #501 and #502 Toronto Canada Tel: 905-881-1049 Cell: 905-515-3434 Fax: 905-881-2241 kiarash@panaceaglobalinc.com
HAAH is a Cancer Biomarker Panacea discovered that HAAH is elevated in the sera of individuals with cancer We have developed a specific and sensitive immunoassay to detect HAAH in serum We have also developed sensitive qrt-pcr methods for detecting HAAH gene expression These assays may be applied as companion diagnostics in various scenarios where there is currently unmet medical need 4
Challenges associated with current Cancer Diagnostics! Current cancer diagnostics tools are not accurate enough! Results turnaround are slow! Associated costs are very high! Early and accurate cancer detection can result in better patient management and cost and Live Saving - Parise, C., et al. Breast cancer survival: The association of age within stage of disease.sutter Institute for Medical Research, Sacramento, CA; J Clin Oncol 29: ( 2011) - Ugnat, AM., et al. Survival of women with breast cancer in Ottawa, Canada: variation with age, stage, histology, PRIVATE & CONFIDENTIAL grade and treatment. 5
Early Cancer Detection and Survival Rate NJM
HAAH: Human Aspartyl (asparaginyl) B - Hydroxylase Panacea s developed diagnostic test is an ELISA-based assay detecting HAAH as an early stage cancer biomarker 7
Panacea Global! Offers a very high accuracy, reliability, fast (one day)results and significant cost-reduction in cancer diagnostic testing! An enzyme that is overexpressed in cancer cells 8
The HAAH Advantage PRIVATE & CONFIDENTIAL 9
Panacea s Highly Sensitive and Specific Test Test Cancer Type Sensitivity* Specificity* Breast Cancer 94% 91% Colorectal Cancer 99% 91% Lung Cancer 98% 90% Prostate Cancer 95% 91% * Accuracy is based on research done through Panacea Laboratories in collaborations with Brown University and Rhode Island Hospital. PRIVATE & CONFIDENTIAL 10
HAAH and Cancer Detection in 857 samples HAAH test scatter chart The scatter chart shows the result of HAAH test as a cancer biomarker on a group of 857 patients composed of 211 individuals known not to have cancer and 646 individuals who are diagnosed with cancer. The cancer group is composed of mix of individuals with different types of cancer (Breast, Prostate, Lung, Colon) in various stages from 1-4. Combining the 12 false positive and 34 false negative results, the test has less than 4.6% error even in such a large group of patients. The patient index PRIVATE & CONFIDENTIAL 11
120 100 HAAH and Cancer Detection in 298 samples 80 60 HAAH LEVEL 40 20 0-20 -40 0 50 100 150 200 250 300 350 298 patients 191 cancer patients different type and different stages 107 individuals known not to have cancer 9 false negative and 17 false positive Kiarash Moshiri and Mehran Bakhtiari - 2013-14
HAAH detected in serum of Prostate cancer pa-ents HAAH detected in serum of Prostate cancer patients/276 HAAH detected in serum of Prostate cancer patient! Results of a clinical study on prostate cancer in collaboration with Brown University! Sample of 233 men with biopsy proven prostate cancer! The test compares Panacea s diagnostics to the conventional PSA method PRIVATE & CONFIDENTIAL 13
Value Proposition: Prostate Cancer Turnaround: 3 6 months Cost per test: $4,000 - $7,000 Turnaround: 1 days Cost per test: $200! Common existing diagnostic modalities: (for suspicious! PSA test (sensitivity 30-40%) patients)! 9 5 % s e n s i t i v i t y v s. 6 4 %! Ultrasound! Digital rectal exam! CT Scan and MRI! Urine for cytology (existing) Collectively % sensitivity! Non-invasive procedure! If negative, stop cancer work- ups! Needle Biopsy! If positive, Biopsy PRIVATE & CONFIDENTIAL
HAAH detected in serum of Lung cancer patients/253 The high sensitivity and specificity of LC Detect has been demonstrated using samples from individuals with different stages of lung cancer, compared with samples from smokers not known to have cancer. PRIVATE & CONFIDENTIAL 15
Value Proposition: Lung Cancer Turnaround: 1 days Cost per test: $200 Turnaround: 3 6 months Cost per test: $15,000 - $20,000! Common existing diagnostic modalities:! CEA blood test (sensitivity 60%) (for suspicious patients)! 9 8 % s e n s i t i v i t y v s. 6 8 % (existing)! Chest X-ray! Sputum for cytology! CT Scan and MRI! Bronchoscope! Thoracotomy! Open lung Biopsy! Non-invasive procedure Collectively 68% sensitivity! If negative, stop cancer work ups! If positive, Biopsy PRIVATE & CONFIDENTIAL 16
HAAH detected in serum of Breast cancer patients/ 247 The excellent sensitivity and specificity of BC detect has been demonstrated using samples from 181 woman with different stages of breast cancer, compared with 32 samples from women not known to have cancer and 35 women with a history of breast cancer and known to be in remission. PRIVATE & CONFIDENTIAL 17
Value Proposition: Breast Cancer Turnaround: 1 days Cost per test: $200 Turnaround: 3 6 months Cost per test: $10,000 - $15,000! Common existing diagnostic modalities:! Breast Discharge (for suspicious patients)! 9 4 % s e n s i t i v i t y v s. 6 8 % (existing) Cytology! Breast Sonography! Mammography Collectively 68% sensitivity! Non-invasive procedure! If negative, stop cancer work! CT Scan and MRI! Breast Biopsy ups! If positive, Biopsy PRIVATE & CONFIDENTIAL 18
HAAH detected in serum of Colon cancer patients/ 145 CC Detect testing should begin at the age 40 and repeated with frequency consistent with American Cancer Society (ACS) recommendations for other colorectal screening tests according to their particular risk factors. PRIVATE & CONFIDENTIAL 19
Value Proposition: Colon Cancer Turnaround: 1 days Cost per test: $200 Turnaround: 3 6 months Cost per test: $15,000 - $20,000! Common existing diagnostic modalities:! OB Stool Exam (for suspicious patients)! 9 9 % s e n s i t i v i t y v s. 8 0 % (existing) (False Negative 9/10)! Colonoscopy! CT Scan and MRI Collectively 80% sensitivity! Non-invasive procedure! If negative, stop cancer work! Colon Biopsy ups! If positive, Biopsy PRIVATE & CONFIDENTIAL 20
UICC Global Partners 21
Our Collaborators and Partners Catalent Pharma Solutions Brown University & Rhode Island Hospital MDS Nordion Collaborators and Partners York University SGS MPI Research Princess Margaret Hospital Sunnybrook Research Institute UICC Charles RiverPathology Associates Bridge Laboratories 22
Intellectual Property Panacea Global has worldwide exclusive rights to patents covering HAAH-related proteins, antibodies, gene pathways for use in all diagnostic applications: US Patent number 6,783,758 issued 08/31/04 US Patent number 6,797,696 issued 09/28/04 US Patent number 6,812,206 issued 11/02/04 US Patent number 6,815,415 issued 11/09/04 US Patent number 6,835,370 issued 12/28/04 US Patent number 7,094,556 issued 08/22/06 US Patent number 7,413,737 issued 08/19/08 AUS Patent number 783327 issued 10/01/05 EU Patent number 1259813 issued 06/28/07 US Patent application number 09/436,184 pending US Patent application number 10/918,685 pending US Patent application number 11/020,965 pending US Patent application number 11/376,941 pending US Patent application number 11/668,421 pending 23
Intellectual Property (Continued) CA patent application number 2390374 pending EU patent application number 07008309.2 pending JP patent application number 2001-536582 pending AUS patent application number 2002303802 pending CA patent application number 2447367 pending EU patent application number 02731861.7 pending JP patent application number 2002-589650 pending AUS patent application number 2005/218044 pending US patent application number 12/055108 pending AUS patent application number 20042912910 pending NZ patent application number 547341 pending CA patent application number 2545893 pending EU patent application number 04819141.5 pending JP patent application number 2006-539985 pending CH patent application number 200480040411.8 pending Hong Kong patent application number pending US patent application number 12/175451 pending 24
Top Ten Medical Breakthroughs- Time Magazine 25