|Onko-Sure & General Cancer Screening in India|
|By Umesh Bhatia, Ph.D. CEO of Jaiva Technologies & NuVax Therapeutics, Inc.|
|Thursday, 03 March 2011 03:08|
An Expert Briefing by Umesh Bhatia, Ph.D. The scientist, entrepreneur and business executive tasked with widespread depolyment of Radient Pharmaceuticals' patented and FDA approved in-vitro diagnostic (IVD) test used in the detection of cancer.
General cancer screening in India using Onko-Sure
JTI announced in January that it plans to target over 2.2 million people in potentially high cancer prone districts of northern India in phase I of its previously launched cancer education and screening program in India. The launch of GDL's cancer education and screening program in India, includes two distinct launch strategies. The first comprises of a widespread deployment of GDL's mobile cancer screening laboratory units where Indian-based physicians and other medical staff travel to local towns to provide counseling and education, along with patient screening using RPC’s Onko-Sure® IVD cancer test. The second program is focused on Company collaboration with Indian government agencies to establish GDL-sponsored cancer screening and testing facilities directly on-site in government hospitals. Physician-referred general cancer screening is being conducted at these hospitals with the goal of administering RPC's Onko-Sure® IVD cancer tests to cancer patients contacted through the program. The goal of both strategies is to reduce the incidence of cancer in India, and through each program, patients will be provided with registered health cards that will track a patient's health records for future reference and statistical analysis. Based on response to initial program outreach, GDL now estimates Onko-Sure test kit usage could potentially reach 25,000 in FY 2011. These estimates are subject to change based on final results of the 64-point questionnaire and these figures have the potential to increase if GDL's results show more than 50% of the patients at high-risk when screened through the 64-point questionnaire.
GDL is the current exclusive distributor for RPC’s Onko-Sure Cancer Test in India
GDL received exclusive rights to market and sell Onko-Sure (previously known as DR-70) in India from RPC via JTI in 2008. Typically, approval to sell a diagnostic test in most countries requires regulatory approval. GDL applied to the Indian Drug Control Agency and the Indian Health Ministry and received approval from the agency about a year later in June 2009 to sell Onko-sure in India as a pan-cancer marker.
Guar Diagno’ previous success in manufacturing, marketing and sales of pharmaceutical products make selling Onko-Sure a sure thing
GDL has been in the pharmaceutical and IVD distribution business for 20 years. It operates a GMP certified manufacturing plant in Northern India and has developed its own products and brands such as: OCSTOCALCUIM (veterinarian supplement); AYUFORTE (male enhancement product), NEPHRONIC (urinary tract infections), ZYRON (iron and calcium supplement) and several others pharmaceutical products. GDL has a strong marketing and sales team in Northern part of India and its products are well known in the Indian medical community. GDL has developed strong ties with the government and public health officials in several Indian states and have spent over a year working with them very closely on the use of Onko-Sure as a general cancer screen. It has been an moving experience on both sides and the good news overall is that the health officials are in agreement that India needs to be proactive in its health approach in general including efforts to curb the incidence of cancer in the country. Despite some delays, the GDL team is now in the process of setting up the required infrastructure for the screening programs and expect to be in full-swing by Q2/Q3 2011. An initial Onko-Sure order for the broad cancer screening programs is anticipated by the end of Q1 2011.
Various approvals for the use of Onko-Sure to detect different cancers
Incidentally, in the US the Onko-Sure is currently only approved for monitoring colorectal cancer. EU nations, Vietnam and Taiwan have approved Onko-Sure for use as a pan cancer test. Why only colorectal cancer in the U.S.? The apparent reason is that the US FDA does not have a mechanism to approve across the board cancer indications, which, turns out to be major disadvantage in the U.S. regulatory system. If we look at the Onko-Sure test data for the last 20 years, there is substantive evidence that Onko-sure is effective in identifying various types of cancer and these clinical results were generated by several independent labs around the world. The fact that the US FDA is not currently approving pan cancer tests is a loss for American cancer patients. A single simple blood test like Onko-Sure, that can tell you if you could have increased risks for 19 different cancer types and frequently identifies in stage 1 or 2 before any visible symptoms, is a fantastic cancer screening and diagnostic tool. Its clear to me, that Onko-sure can save lives through early cancer detection.
Early cancer detection in private hospitals in India
GDL has taken this concept of early detection and developed mass screening programs in certain potentially cancer prone areas in India. But the road has been tedious. When we first introduced the product in India to the Oncologists and though leaders in the field, there was a genuine and unanimous concern: Have you done a study in the Indian population? This concern was valid, since we know that, in general, data from one genetic pool may not translate to another. Therefore, Gaur Diagno embarked on completing several small Onko-Sure blind studies in 2010 with key cancer centers such as the: Rajiv Gandhi Cancer Hospital, Batra Hospital and Research Center, Moolchand, Delhi Hospitals and the Healthcare Global Enterprises (HCG). The results were across the board relaying the same message: ”There is a good correlation between the clinical picture of cancer patients and the Onko-sure test”. Then GDL completed another joint study with scientists at the Super Religare laboratories (formerly a Ranbaxy company), which is India’s largest competitor in the diagnostic business. Again the results were fantastic. The clear importance of these pilot studies is that in multiple healthcare institutes, Onko-sure was put to the test and the results consistently showed that Onko-sure works extremely well as a pan cancer marker. Scientifically speaking, when independent labs deliver the same conclusions a very robust and unequivocal finding emerges. As a consequence of these pilot studies, both GDL and Religare have now executed a long-term collaboration where Religare, with the assistance of GDL, will drive sales of Onko-sure to the private hospitals and doctors sector eventually deploying 400 sales people to the task.
Early cancer detection in government sponsored programs in India
The big play for GDL is not the private hospitals and doctors; rather it’s government sponsored mass cancer screening programs. The joint effort with the government and health agencies in India is providing institutional based mechanisms, which are instrumental to curb the incidence of cancer. The initial area targeted is for approximately 200,000 individuals in Northern India, where apparently the rates of cancer are high around certain pockets in the region. The program involves setting up day camps in villages and providing counseling and education regarding the importance of early detection and the lifestyle changes that reduce the chance of developing cancer. The focus is on identifying those individuals who may be susceptible to developing cancer prior to running an Onko-sure test. To reduce the rates of false positives a questionnaire screening tool is used to determine if an individual has a high risk of developing cancer. These high risk individuals are then tested with Onko-sure.
The government and NGO’s (non-profit organizations) underwrite the cost of these tests for those individuals whose income lies below a standard poverty line and would not otherwise be able to afford the test. In addition, the government and health agencies provide facilities, staff of doctors and nurses and transportation. GDL in turn runs the entire program, sets up the lab in the government hospital and tabulates and reports results of the screening. Those individuals who are not below the poverty line, will be charged a largely subsidized fee for the test and part of the profits go back to the government, who in turn used the funds to increase the availability of treatments or to improve their infrastructure for those who are below the poverty line. One of the issues in such a program that we were facing is how does the government provide treatment to those who score positive and are dependent on government facilities. Where would the funding come from? We solved the problem to some extent by providing some funds back to the health and government agencies through the income generated in these programs. GDL anticipates that it will gradually expand these programs in most of the states in India. There has been a very good response to our program. GDL will also work to collaborate with the World Health Organization (“WHO”), which could provide support at various levels for the development of a nationwide screening program.
Its important to note that without Onko-sure, it would be extremely cumbersome and not practical to carry out these screening programs. Just think about it. We have several major cancers: Breast, cervical, lung, colon etc. If our team is testing people in the villages we’ll have to do a mammogram, pap smear, X-ray and on and on. This would require us to haul these machines with us in our vans which is not practical and still there are other cancers that would go undetected. But that’s what I like about Onko-sure, it provides a first pass in telling us if someone has or maybe is in the risk zone of developing cancer. I’m not aware of any other test that can reliably detect several types of cancers in a single test.
NuVax cancer therapeutics
We’re very excited to be working on cancer treatments. NuVax Therapeutics is a newly formed Radient subsidiary company developing cancer immune-gene therapeutics. We are planning human clinical trials for cancers such as virus induced lymphomas, multiple myeloma, pancreatic and lung cancer. Our initial phase I results are quite promising and many analysts and doctors in the immunotherpay space have taken notice. From a valuation perspective, there are comparable high valuations in the space: e.g. Dendreon ($5B) and Biovex ($1B). We anticipate NuVax’s developments could deliver significant value to both shareholders of RPC and NuVax. We will have more to report about NuVax and our approach to cancer treatment very soon.
Dr. Bhatia is a scientist, entrepreneur and business executive. He is currently President and CEO of NuVax Therapeutics, Inc. and Jaiva Technologies, Inc. He was previously an investment executive and banker at Breakwater Investments and US Capital Corp focusing in the small and lower middle markets. Dr. Bhatia was educated and trained under Nobel laureate Dr. Walter Gilbert at Harvard University and has published over 40 peer reviewed scientific publications and patents. He has worked at various levels, both in large and in small pharmaceutical and biotech firms. His tenure includes Novartis and Incyte Pharmaceuticals and has been involved in several start-ups either as CEO or as an senior advisor.