Last week there were changes done in the TNBC study. Before a patient starts the TNBC trial, both estrogen receptors and progesterone receptors are tested. Different labs have different cutoff points for calling the cancer either hormone-receptor-positive or hormone-receptor-negative. For example, if less than 10% of the cells stain positive, one lab might call this a negative result. Another lab might consider this positive, even though it is a low result. Research studies have shown that even cancers with low numbers of hormone receptors may respond to hormonal therapy, which is what Oncosec is looking for with a low requirement of 5%. Since ER-negative tumors have 1 – 9% positive cells, the TNBC study has been modified to increase the percentage of cells staining, giving a range of 5-10%.
Therefore, the inclusion criteria has been expanded as follows:
*Treatment refractory disease is defined as the persistence of tumor lesions following at least one intervention that may include chemotherapy, radiation and/or surgery, or any combination thereof.
*Patients must have both ER and PR staining of 5% and be HER2-negative. Patients with ER or PR staining of 5-10%, but who have historically been treated as TNBC may also be enrolled.
*Patients must not have disease that, in the opinion of the investigator, is considered amenable to potentially curative treatment.
Notice from this last added inclusion that intratumoral plasmid IL-12 electroporation in patients with TNBC will be tested as a last line of therapy.
In addition, the non-vaccination requirement was changed to include patients who have been vaccinated against Hepatitis B and who are positive for ONLY the Hepatitis B surface antibody are permitted to participate in the study.
Coincidently, a recent study has shown high rate of Hepatitis B reactivation in Chinese patients receiving Rituximab (chemotherapy) for Lymphoma. It seems Oncosec is aiming to cover the higher demand, keeping in mind their Chinese patent.
Whoever prepared the study did not think through some details, and my guess is that it was done by the former CMO, Dr. Mai H. Le.
