Cures Within Reach For Cancer - More Information


 

Each year around the world, more than 8 million people die from cancer and more than $1 trillion is spent on cancer care. We clearly need more effective and less expensive cancer treatments. There is an exciting opportunity to rapidly make highly effective, inexpensive “new” cancer treatments available to patients by repurposing drugs already approved by regulatory agencies for human use in non-cancer indications. Yet most of these promising cancer treatments are currently ignored because repurposing inexpensive and widely available drugs is usually not profitable. Therefore, regardless of scientific merit and potential efficacy, funding for the definitive clinical trials is unavailable. This creates many missed opportunities to improve cancer outcomes and decrease the cost of cancer care.

pillsRepurposing older drugs whose patents have expired and where generic versions are available offers several advantages. New drugs take more than 10 years and $1 billion to gain approval and have less than a 10% success rate (safety and efficacy endpoints that allow regulatory approval), often due to toxicity. Generics have a long history of safe patient use and existing clinical efficacy data for cancer in some cases, so the success rate (for off-label use or regulatory approval) is expected to be much higher. Clinical development for a repurposed generic will likely cost less than $10 million and could transform the standard of care for cancer in less than 5 years. Additionally, new cancer drugs cost the U.S. healthcare system more than $100,000 per year while generics often cost less than $5,000 per year. One might think that these repurposed drugs could only have marginal efficacy, but the opposite is true – based on the initial published studies (e.g., Forget et al.), the treatments could be revolutionary.

New uses for drugs are continually being discovered based on our evolving understanding of cancer and ability to perform high-throughput in vitro and in silico screens. Furthermore, retrospective analyses from data mining patient information in electronic medical records is uncovering differential cancer survival of patients treated with various non-cancer drugs. There are around 2,000 FDA-approved generic drugs and more than 3,000 other inexpensive and potentially repurposable “drugs” such as nutraceuticals. More than Doctor100 generic drugs approved for non-cancer indications, such as nonsteroidal anti-inflammatory drugs and anti-malarial, anti-fungal, and diabetes drugs, have already shown efficacy for treating cancer, many in randomized clinical trials (ReDO Project, Pantziarka et al., Bertolini et al., Blatt et al., Holmes et al., Saxena et al.). These repurposed generics could increase the efficacy of on-patent drugs for a marginal increase in price – an important consideration as the cancer field moves toward more combination therapies, which are a huge financial burden to healthcare payers and society.

Nevertheless, these very promising treatments are being overlooked because funding is not available for the clinical trials that are needed for the treatments to become standard of care for cancer. Governments and cancer foundations fund some pre-clinical studies and small clinical trials for generic drug repurposing, but they very rarely fund larger Phase II/III trials. This is because the trials are costly and would severely CWR for Cancer logolimit the number of studies they can fund, and they assume that pharmaceutical companies will fund the large trials. Yet pharma cannot recoup development costs and earn the profits that their investors require since the drugs are off-patent and inexpensive.

Cures Within Reach for Cancer aims to create a new drug development paradigm that takes advantage of expired patents, low cost, and extensive patient experience to get new cancer treatments, based on repurposed generics, to patients as quickly as possible. The focus is on using these drugs “as is,” since reformulation, changes to the delivery, and other methods used by drug companies to secure market exclusivity are often unnecessary for efficacy.

Cures Within Reach for Cancer is raising awareness of this gap in our drug development system and addressing key challenges to getting these treatments to cancer patients through: 1) curation and prioritization of the large amount of existing pre-clinical and clinical data on repurposed drugs for cancer, 2) funding and facilitating Phase II/III clinical trials, and 3) advocating for changes to standard of care hands inbased on successful trials. Mechanisms to fund and stimulate repurposing include philanthropy, foundation and government grants, social impact bonds, crowdfunding, orphan drug incentives, FDA priority review vouchers, and payer consortia for indication-based drug pricing. Policy changes, re-aligning of incentives, new partnerships, and international collaboration are crucial to enable validation of these therapies and ensure that medical practice changes worldwide.

 

For more information or to get involved, please contact Laura Kleiman at laura@cureswithinreach.org.

 

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