Cancer diagnostics company Biomoda, Inc. (OTC BB: BMOD) today announced in its new monthly President's Column, posted at www.biomoda.com, that it is extending the pilot clinical trial of its CyPath® diagnostic assay for the detection of early-stage lung cancer to recruit additional participants for the positive control group, patients who have been diagnosed with lung cancer but have not yet begun treatment for the disease.
“The primary purpose of the pilot trial is to assess the specificity and sensitivity of the CyPath® assay and generate sufficient data to move forward with the pivotal clinical trial”
"The primary purpose of the pilot trial is to assess the specificity and sensitivity of the CyPath® assay and generate sufficient data to move forward with the pivotal clinical trial," Biomoda President John Cousins said. "The positive control group is critical to assessing the sensitivity of the CyPath® assay. We have had to exclude samples from a significant number of participants in the positive control group from our analysis. Consequently, we plan to add at least one additional enrollment site to expedite recruitment and completion of the study."
Cousins acknowledged that identifying patients to participate in the positive control group has been a challenge. "It has been difficult to recruit diagnosed pre-treatment patients who are able and willing to give their truly precious time to our study. We thought we had secured sufficient samples, but further investigation showed that some of these lung cancer patients do not fit the FDA-approved criteria for inclusion in the positive control group. Some of the patients' cancer is located outside the lung cavity. Under the protocol submitted to the FDA, these patients must be excluded from the study," Cousins said in his President's Column (posted at www.biomoda.com) updating the status of the clinical trial and other company activities.
"We are still confident the results of our lung cancer pilot study will be more than sufficient to lay the foundation for our pivotal study," said Cousins.
Biomoda's CyPath® labeling solution for the early detection of cancers binds to cancer cells and fluoresces under specific frequencies of medium light. Biomoda is seeking Food and Drug Administration (FDA) approval of its cytology-based screening technology as a Class III medical device. Pending FDA approval, CyPath® is for investigational use only.
Engineered SNIPRs transform CAR T-cell precision for safer cancer therapy