BOSTON, March 28, 2017 /PRNewswire/ -- Oncology journal, Oncotarget, has published a pre-print of the research conducted by the Boston based biotech start-up CureLab Oncology, Inc. The paper describes the results of phase I/IIa clinical trials of a novel therapeutic anti-cancer DNA vaccine, Elenagen™. The research demonstrated both the first encouraging evidence of its clinical benefits for cancer patients as well as an excellent safety profile.
The clinical trial involved 27 adult terminally ill patients who have exhausted all available options of care and still had an actively progressing disease. The main goal of the phase I clinical trial was to test the safety of Elenagen™. Previously, the CureLab Oncology team has demonstrated that Elenagen™ acts via the immune system. Currently, a very high level of toxicity is reported for most of the anti-cancer drugs which act through the immune system. Nevertheless, no patients in the trial have developed any significant side effects. The level of discomfort experienced by the patients was typical for well-tolerated injectable drugs.
Prof. Alexander Shneider, founder of CureLab Oncology said that "Based on the results we received, we plan to focus our phase IIb/III clinical trials on ovarian and breast cancers. According to the clinical trial guidance, at phase I we had to apply Elenagen™ by itself (not in combination with other drugs). A regimen such as this is least likely to work because in real life doctors often combine drugs to complement and amplify each other. Still, even when applied alone, Elenagen™ stopped the progression of ovarian cancer in 4 out of 6 women, and the progression of breast cancer in 4 out of 8 for the duration of 2 to 6 months."
Although it was not a part of the formal clinical trial, researchers gave chemotherapy to 10 of the women when their tumors progressed after one or several rounds of Elenagen™ treatment. This was not an obvious decision because each of these patients have previously failed up to 8 lines of chemotherapy. Nevertheless, all 7 breast and 3 ovarian cancer patients have responded to chemotherapy after receiving Elenagen™. Thus, Elenagen™ may be the first drug which restores tumor sensitivity to chemotherapy. In the upcoming phase IIb/III clinical trials, the researchers plan to apply Elenagen™ in combination with radiation and chemotherapies.
"We don't think Elenagen™ competes with any existing treatments," said Vlad Gabai, Ph.D., VP of R&D at CureLab Oncology, also a faculty member of department of biochemistry at Boston University, "instead, we think it would be combined with other standards of care and synergize with them."
Elenagen™ is a plasmid, or a circular DNA, encoding a protein called p62-SQSTM1, which is a key component of the autophagy system. The autophagy system is located within a cell and maintains "order". In 2016, the Nobel Prize was awarded for the discovery of autophagy.
Elenagen™ was invented in Boston, and subsequently tested on mice and dogs in the USA, Italy, Russia and Ukraine. The clinical trial took place Russia. The next phases of the clinical trials are planned to be conducted in America, Europe, Israel and Russia.
The Oncotarget paper which demonstrates that Elenagen™ is safe and clinically beneficial at the level equivalent to the best anti-cancer immunological drugs is available online http://www.impactjournals.com/oncotarget/index.php?journal=oncotarget&page=article&op=view&path[]=16574&author-preview=cse.
About CureLab Oncolgoy, Inc.
CureLab Oncology, Inc. is a private biotechnology company developing biological agents against cancer and chronic inflammation. The advisory board of the company includes experts from scientific talent (including a Nobel laureate) to business gurus.
For more information please visit www.CureLabOncology.com
Contact: Moish Soloway, 9.8 Group[email protected](212) 964-0030, ext. 169
Advertisement
The clinical trial involved 27 adult terminally ill patients who have exhausted all available options of care and still had an actively progressing disease. The main goal of the phase I clinical trial was to test the safety of Elenagen™. Previously, the CureLab Oncology team has demonstrated that Elenagen™ acts via the immune system. Currently, a very high level of toxicity is reported for most of the anti-cancer drugs which act through the immune system. Nevertheless, no patients in the trial have developed any significant side effects. The level of discomfort experienced by the patients was typical for well-tolerated injectable drugs.
Advertisement
Prof. Alexander Shneider, founder of CureLab Oncology said that "Based on the results we received, we plan to focus our phase IIb/III clinical trials on ovarian and breast cancers. According to the clinical trial guidance, at phase I we had to apply Elenagen™ by itself (not in combination with other drugs). A regimen such as this is least likely to work because in real life doctors often combine drugs to complement and amplify each other. Still, even when applied alone, Elenagen™ stopped the progression of ovarian cancer in 4 out of 6 women, and the progression of breast cancer in 4 out of 8 for the duration of 2 to 6 months."
Although it was not a part of the formal clinical trial, researchers gave chemotherapy to 10 of the women when their tumors progressed after one or several rounds of Elenagen™ treatment. This was not an obvious decision because each of these patients have previously failed up to 8 lines of chemotherapy. Nevertheless, all 7 breast and 3 ovarian cancer patients have responded to chemotherapy after receiving Elenagen™. Thus, Elenagen™ may be the first drug which restores tumor sensitivity to chemotherapy. In the upcoming phase IIb/III clinical trials, the researchers plan to apply Elenagen™ in combination with radiation and chemotherapies.
"We don't think Elenagen™ competes with any existing treatments," said Vlad Gabai, Ph.D., VP of R&D at CureLab Oncology, also a faculty member of department of biochemistry at Boston University, "instead, we think it would be combined with other standards of care and synergize with them."
Elenagen™ is a plasmid, or a circular DNA, encoding a protein called p62-SQSTM1, which is a key component of the autophagy system. The autophagy system is located within a cell and maintains "order". In 2016, the Nobel Prize was awarded for the discovery of autophagy.
Elenagen™ was invented in Boston, and subsequently tested on mice and dogs in the USA, Italy, Russia and Ukraine. The clinical trial took place Russia. The next phases of the clinical trials are planned to be conducted in America, Europe, Israel and Russia.
The Oncotarget paper which demonstrates that Elenagen™ is safe and clinically beneficial at the level equivalent to the best anti-cancer immunological drugs is available online http://www.impactjournals.com/oncotarget/index.php?journal=oncotarget&page=article&op=view&path[]=16574&author-preview=cse.
About CureLab Oncolgoy, Inc.
CureLab Oncology, Inc. is a private biotechnology company developing biological agents against cancer and chronic inflammation. The advisory board of the company includes experts from scientific talent (including a Nobel laureate) to business gurus.
For more information please visit www.CureLabOncology.com
Contact: Moish Soloway, 9.8 Group[email protected](212) 964-0030, ext. 169
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/curelab-oncology-inc-publishes-results-of-phase-iiia-clinical-trials-of-its-anti-cancer-dna-vaccine-elenagen-300429682.html
SOURCE CureLab Oncology, Inc.
