Posted by: Pekka Simula | July 26, 2010

Personalizing medicine and clinical development: Advanced Therapy Access Program

The drug development industry has been slow to adapt development of personalized medicine – for obvious reasons: Regulations will not change overnight. Still, the US Department of Health and Human Services estimate that less than 60% of patients benefit from prescribed drugs. Not a very impressive customer satisfaction poll result. Can’t we do any better?

I believe that the Advanced Therapy Access Program (ATAP) of Oncos Therapeutics is a glimpse to the future of drug development. Many other industries have already successfully implemented adaptive approaches over the past decades. As a global first, Oncos has introduced ATAP as an adaptive approach to clinical R&D.

ATAP is intended for cancer patients who seek experimental treatments after routine therapies have failed. Therefore strict ethical principles apply. For instance, patients may only enroll in ATAP if they have a progressing disease after those routine therapies. All therapeutic and diagnostic interventions are planned with the benefit of the patient in mind. However, in a perfect marriage of patient needs and improvement of the science, all data is collected and analyzed carefully which helps improve the approach further. Patient’s informed consent and medical inclusion and exclusion criteria are most important. Under conditions carefully monitored by regulatory authorities, 200 patients representing 18 cancer types have been treated in ATAP with 9 different oncolytic adenoviruses, often in combination with drugs that enhance the oncolytic effect. Thus, the overall number of different treatment combinations is several dozen. How many clinical trials would it have taken to learn as much of safety and efficacy – on a personalized level?

The benefits of ATAP compared to a traditional clinical development are enormous. The treatment course is planned and adjusted for each patient based on individual needs and signs of efficacy, with a variety of therapeutics and combinations to choose from, for truly personalized care. The oncologists learn more with each treatment to benefit the same patient in consecutive treatments and also future patients. The scientists will gain a much better understanding of activity in humans – another huge benefit since in oncology preclinical data often fail to predict true clinical efficacy.

Cancer is an immensely complex and versatile disease group. By definition, treatment for each patient is always personalized, starting from the optimal combination of therapies: Chemo, radiotherapy, etc. However, this has not been the case in clinical trials which typically follow strict and inflexible protocols and whose results do not always reflect the practical situation. With the face of oncology turning towards increasingly complex biological agents and regimens, personalization will have to extend to the level of trials. Today, there are few examples such as ATAP, or the FDA-approved experimental I-SPY 2 trial. Over the next years we will see many more.

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