Sri Lanka Country Report Oncology: Early detection, saves lives Therapeutic capacity presentation series. V.1.0

Transcription

1 Sri Lanka Country Report Oncology: Early detection, saves lives Therapeutic capacity presentation series. V.1.0

2 Country Overview Size: 65,610 sq km Population: 21,324,791 Population growth rate: 0.904% Population: Not genetically homogeneous and stable in terms of internal migration Life Expectancy: Male 75 Female 77 Literacy rate: 92.38% (M: 94.5%, F: 90.6%) Business Language: English Per Capita Income: USD 2053 Per Capita GDP (PPP): USD 4,500 Growth Rate: 6.4% Inflation Rate: 2.4% Form of government: Executive Presidency / Parliament Administrative Units: Nine provinces

3 Cancer prevalence In 2012, 14.1 million newly diagnosed cases were reported, globally million people living with cancer within 5 years of diagnosis, globally. in 2012, 57% of newly diagnosed cases, 65% of death due to cancer and 48% of the 5-year prevalent cancer cases occurred in less developed countries.

4 Trends in incidence of cancer in selected countries in 2012 Age-standardized rate (W) per 100,000 men Age-standardized rate (W) per 100,000 women

5 Trends in mortality from cancer in selected countries in 2012 Age-standardized rate (W) per 100,000 men Age-standardized rate (W) per 100,000 women

6 Risk of developing and dying from cancers in males and women The lifetime risk of developing or dying from cancer refers to the chance a person has, over the course of his or her lifetime of being diagnosed with or dying from cancer The graphs below indicate the comparison between males and females lifetime risks of developing and dying from certain cancers The information is from the US National Cancer Institute s Surveillance Epidemiology and End Results (SEER) Database, and is based on incidence and mortality data for the United States from 2010 through 2012.

7 Life time risk of developing cancer (%) Risk of developing cancers in males and women 45 Risk of developing cancers in males and females Male Female

8 Life time risk of dying from cancer (%) Risk of dying from cancers in males and women 25 Risk of dying from cancer in males and females Male Female

9 Cancer: A disease burden in Sri Lank? According to the World Health Organization (WHO), Sri Lanka has the highest NCD burden in Southeast Asia. In the past decade, the prevalence of cancer has increased in Sri Lanka. According to the latest published National Cancer Incidence data in 2010, one in every 10 Sri Lankans carries a life time risk of developing cancer. A total of 16,963 new cancer patients were registered for treatment during the year 2010, comprising males 7,993 and females 8,970. In Sri Lanka, the number of cancer patients has steadily risen in the past few years to an extent where it has become the second highest cause of hospital deaths in the country.

10 Cancer: A disease burden in Sri Lank? The crude incidence rate (CR) for all cancers was 82.1 per 100,000 population. The most common cancer among females is breast cancer with a CR of The male cancer with the highest incidence is cancer of the lip, oral cavity and pharynx CR=18.4. The cancer with the highest life time risk of developing among females is breast cancer 1 in 40 females. The highest life time risk observed for males 1 in 40 males for lip, oral cavity and pharyngeal cancers. According to the published data of the Registrar General s Department, 6438 male deaths and 5398 female deaths have occurred due to neoplasms. Out of those 6371 male and 5349 female deaths were due to cancer. A gradual increase in the proportionate mortality ratio for neoplasms could be observed from 2001 to 2010 (7.1 in 2001 to 9.1 in 2010). Source: Cancer incidence data (2010)

11 Number of cases diagnosed with cancer Male Female Total Male Female Total Male Female Total Male Female Total Male Female Total Male Female Total Cancer in Sri Lanka: Statistics Cancer incidence by gender, Source: Cancer incidence data (2010)

12 Cancer in Sri Lanka: Statistics Source: Cancer incidence data (2010)

13 Cancer in Sri Lanka: Statistics Source: Cancer incidence data (2010)

14 Cancer in Sri Lanka: Statistics Source: Cancer incidence data (2010)

15 Cancer in Sri Lanka: Statistics Source: Cancer incidence data (2010)

16 Cancer diagnosis of common cancers (2010)

17 Treatment of cancers (2010)

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19 RemediumOne: Oncology Trial Successful managing a multicenter study in Sri Lanka Experienced investigators Efficient and clearly defined regulatory review process Experienced coordinators Experienced allied health staff High rate of protocol compliance Robust project delivery system and quality assurance

20 RemediumOne: Delivery System Project Management Recruitment & Retention Performance Management Data Management Administration Safety & Compliance

21 Our Hands-On Clinical trial experience different therapeutic area RemediumOne: Growth underpinned by robust quality and safety focus Clinical trials hands-on experience Completed and On Going Trials Vaccine trial Respiratory trial Nephrology trial Pediatric trial Opthalmology trial Autoimmune trial Cardiovascular trial Oncology trial Diabetes trial Rheumatology trial Gastroenterology trial Years

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23 RemediumOne: Overcoming cancer in Sri Lanka Oral cavity cancer Colorectal cancer Metastatic breast cancer No, of sites: 02; 02 Tertiary care hospital Status: On-going Recruitment target: 50; recruitment completion planned for Dec 2017 Experienced staff ranging from 02 PIs, 02 Co-Is, 08 Sub-Is, 03 study nurses, 06 surgeons, 03 pathologists, 02 pharmacists, 03 radiologists, 01 radiographer, 02 radiophysician and 03 study coordinators. No, of sites: 01; 01 Tertiary care hospital Status: On-going Recruitment target: 29; recruitment completion planned for Dec 2017 Experienced staff ranging from 01 PIs, 04 Sub-Is and 02 study coordinators No, of sites: 01; 01 Tertiary care hospital Status: On-going Recruitment completed: 26 Apr 2013 Experienced staff ranging from 01 PIs, 04 Sub-Is, 01 study nurses and 02 study coordinators

24 RemediumOne: Oral cavity cancer study timeline E N R O L L M E N T R A N D O M I Z E Group 1: Multikine 5X/week X3 week +CIZ Group 2: Multikine 5X/week X3 w/o +CIZ Group 1: Standard of Care Group S** U R G E R Y RTx Radiotherapy Gy, 30 fractions over 6-7 Weeks*** -OR- CRTx ****High Risk: Concurrent radiochemotherapy Gy, fractions, over 6-7 weeks + IV cisplatin (100mg/m 2 ) 1X/week X 3 weeks (week 1, 4 and 7) on days 1, 22 and 43 of radiotherapy course given within +/- 3 days for each scheduled day of administration of chemo during the radiotherapy period. Month 1 Month 2 Long Term Follow-up CIZ: Cyclophosphamide 300 mg/m2 (x1, IV, Day -3); Indomethacin 25mg tid, po (Day 1 to approximately 24 hours prior to surgery) + Zinc (as Multivitamin) po Id daily (from day 1 to approximately 1 day prior to surgery) ** Surgery: complete surgical resection of primary tumor and any positive lymph nodes. *** Radiotherapy is to be given per protocol at a total of 60 Gy to 70 Gy (in fractions over a 6-7 week period) **** High risk subjects are defined as those with: positive surgical margins, 2 or more clinically positive nodes, or extracapsular nodal spread (any or all of the above).

25 RemediumOne: Colorectal study timeline 05 years follow-up Long Term Follow-up Patient Randomization Aspirin 200 mg OD for 3 years Placebo 200 mg OD for 3 years 3 monthly follow-up for 3 years 6 monthly follow-up for 2 years Year 7 Year 12 Colon/Rectal cancer subgroups Surgery Standard Therapy At least 3 months Randomize

26 Access to potential investigator centers Jaffna Teaching Hospital Anuradhapura General Hospital Kurunegala Teaching Hospital Batticaloa Teaching Hospital Kandy Teaching Hospital Provincial General Hospital, Badulla National Cancer Institute National Hospital of Sri Lanka Provincial General Hospital, Ratnapura KarapitiyaTeaching Hospital

27 Study Status VISION (Our aspiration) To become the most valued partner to our Clinical Development and Life Sciences clients and a role model to our industry. VALUES (what we believe) CLIENT FOCUS ACCOUNTABLE RESPECT ENDURE Responsible, responsive attitude to our clients Ownership, honesty and integrity Honest, transparent, fair in our actions and communication Perseverance and belief in enduring partnerships inquiries@remediumone.com

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