CureLab Oncology invited to present on OncologyTube
Dr. Alex Shneider and Prof. Sergei Krasny discuss results from clinical studies underway in Belarus.
In August of this year, CureLab’s clinical research team published preliminary clinical results from its studies of the effects of administering Elenagen in combination with standard chemotherapy to treat triple-negative breast cancer (TNBC). TNBC is one of the deadliest cancers, constituting 10-20% of all diagnosed breast cancers. Patients with progressive Stage IV TNBC demonstrating metastasis in remote organs have only a 12% five-year survival rate.
The big takeaway from these results: both the primary tumors and metastases are getting smaller; some have even disappeared. For some of patients the patients who were administered Elenagen, the disease does not disappear but does not progress for a period longer than for the patients in a control group. Meanwhile, the quality of life for these patients remains good. You can read more about the study here.
Based on these results, CureLab Oncology submitted two papers to the prestigious ESMO Conference, both of which were accepted for presentation in September of this year. We also invited journalists and editors at the most prominent healthcare science and oncology publications to report on this, and we were delighted to be selected by OncologyTube to present our findings to our fellow oncology scientists.
Along with our OncologyTube host, Stephanie Comello, we also discussed the expansion of our study to include hormone-resistant prostate and breast cancers. If you have 30 minutes, we invite you to watch the video. But for those who would rather just read along, here are the highlights.
Stephanie Comello: Please could you describe the study and the clinical data?
Professor Sergei Krasny: The clinical protocol for the original study was developed by an international team that included oncologists from Belarus National Cancer Center and Minsk City Oncology Center, together with colleagues from MD Andersen Cancer Center, NYU, and Thomas Jefferson University.
We randomized patients diagnosed with metastatic triple-negative breast cancer into two groups. Patients in the control group received standard CMF chemotherapy: Cyclophosphamide 600 mg/m2 + Methotrexate 40mg/m2 + Fluorouracil 600mg/m2administered IV, on day 1 and day 8, which is repeated every 4 weeks. Patients in the experimental group received the same chemotherapy plus p62-encoded plasmid, Elenagen™ IM once a week at a rate of 2.5 mg per injection. The efficacy of the treatment is assessed according to the RECIST 1.1 criteria. The toxicity of the treatment is documented according to CT CAE version 4.0.
What really got our attention: when Elenagen was added to the treatment regimen, all patients showed complete or partial regression of the primary tumor and associated metastases in the lungs, liver, lymph nodes, and bones.
In two Elenagen-treated patients, a radical operation was performed, and no tumor cells were found in the removed material. All patients continued to receive Elenagen per the above protocol. So far, only one patient showed disease progression, which started 42 weeks after starting treatment.
In contrast, 50% of patients receiving standard chemotherapy demonstrated disease progression at week 26. The difference between the groups was shown to be statistically significant (p = 0.049).
In the picture above, you can see a complete response in a patient before and after six months of treatment with CMF plus Elenagen. Both the primary tumor and the metastases are visible in the upper panel before the treatment, while they are fully regressed in the bottom panel, presumably due to the Elenagen combination treatment.
Another study arm includes platinum-resistant ovarian cancer patients. Patients are randomized 1:1 to receive either Gemcitabine alone, 1000 mg/m2 on day 1 and 8 of a treatment course, then repeated every 3 weeks; or Gemcitabine using the same administration protocol in a combination with Elenagen at the same dosage as in the breast cancer arm of the study.
Our initial results suggest the patients could see a doubling of the progression-free survival time. In some patients, a partial response was registered such as reduced tumor and metastatic lesions, which meant the patient became a candidate for operable surgery.
We think a higher number of patients will be necessary to conclude the effect with statistical confidence. Possibly due to the Covid pandemic, enrollment into the study has been much slower than expected and what was seen in our other studies prior to 2020. Still, if similar results are seen as the study continues, the addition of Elenagen shows great promise to helping manage triple negative breast cancer and platinum resistant ovarian cancer patients.
Finally, it is important to mention a very strong safety profile of Elenagen. If we combine the number of patients who received Elenagen in our study with the number of patients receiving Elenagen in a previously published phase I/IIa study, the total exceeds 100 patients. The corresponding data shows none developed a serious adverse reaction.
Encouraged by these results, we are continuing our study with cautious optimism.
