The drug development process is quickly taking on more of a patient-centric approach. As biotechnology company CytoDyn Inc. (OTCQB: CYDY) is aware, possible rejections of drugs by the U.S. Food and Drug Administration (FDA) don’t necessarily point to a failure. Real world data collection, incorporating scientific data and patient feedback, is aiding research and development and giving many stakeholders in the clinical trial process new capabilities. The recent decline of Orphan Drug Designation (“ODD”) for PRO 140 by the FDA, announced in a Biotech & Pharma story (http://nnw.fm/hFU48), was because the agency believes it can be used to treat a broader population with human immunodeficiency virus (HIV). Instead of a smaller subgroup of HIV patients (less than 200,000 patients), it thinks a potential monotherapy could eventually be available, suitable for all people with the virus that are infected by the R5 strain of HIV. The drug development path isn’t always a smooth one, and the true implications may not be known for some time.
CytoDyn specializes in humanized monoclonal antibodies and their clinical development. Its groundbreaking advancements in treatments for HIV and other immune deficiency viruses are providing ample opportunities for investors. CytoDyn’s drug under study has a fast track designation from the FDA. The company intends for it to be used both as part of a combination therapy and as a standalone drug, and a recent Letter to Shareholders (http://nnw.fm/1Wt6D) explored the highlights of both. This notice expressed the largest market opportunity may be use as a monotherapy. However, PRO 140 is not only being explored for HIV treatment; it’s also being studied in a Phase 2 graft vs. host disease (GvHD) trial for patients with acute myeloid leukemia or myelodysplastic syndrome who are undergoing a bone marrow transplant and are in danger of developing GvHD. These patients have a significantly decreased one-year survival rate, with relapsed GvHD as the leading causes of death.
According to Transparency Market Research, the current U.S. HIV therapy market is valued at around $20 billion. The CytoDyn drug candidate addresses the shortcomings of the current standard of care (Highly Active Antiretroviral Therapy), which include side effects, toxicities, drug resistance, and patient compliance. In a recent study of over 200 patients, it yielded no serious side effects or toxicity.
For updates on clinical trials and approvals, and information for investors, visit CytoDyn Inc. online at www.cytodyn.com.
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