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Clinical Development
Overview
Apthera discovers, develops and produces immunotherapies for significant unmet medical oncology (cancer) needs using the scientific advances in biotechnology and immunology.
The primary goal of Apthera's product development effort is to conduct the necessary clinical trials to obtain the medical data that facilitates prompt regulatory approval for the product's use described by the product label and under the supervision of licensed physicians. Clinical trials are underway to evaluate NeuVax as a treatment for certain HER2-expressing cancers. For details on the Company's products in clinical development and the status of each study, refer to our Products section.
Corporate Sponsored IND or Protocol
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Apthera will provide access to its investigational drug under a Corporate Sponsored IND. Upon completion of the pivotal phase III trial, it is anticipated that the information will demonstrate sufficient safety and effectiveness to warrant seeking regulatory approval. |
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The starting date of the phase III protocol will be dictated by regulatory (FDA) clearance to enroll patients and collect data. |
c. |
Patients eligible for this protocol must meet the criteria established for enrollment in the pivotal Phase III trial. |
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