Posted on June 25th, 2014
by Douglas Losordo
Even if you have never had cancer you probably know that treatment for cancer is rough. Nausea, plummeting blood counts, risk of life threatening infection, hair loss ….the list goes on. In fact, the toxicity of cancer treatments is so common that among cancer doctors it’s more or less expected. I’ll come back to that a little later.
But it turns out that that might not have to be the case.
A year or two before I joined NeoStem I was at a meeting on “Cell Therapy” and I saw a presentation of data from a randomized, blinded Phase 2 investigational study of a cell based treatment for metastatic melanoma. Melanoma is the most lethal form of skin cancer and once it reaches the stage of being recurrent or metastatic it is almost uniformly fatal, with only a small percentage of people surviving. The presentation described a new therapy in which each patient’s tumor was used to train the patient’s own immune system to attack the tumor. The data from the clinical study showed that the treated patients had more than a doubling of their two year survival, from 31% for controls to 72% for those who received the novel therapy.
At the recent American Society for Clinical Oncology meeting in Chicago, a pooled analysis of data from three trials for this melanoma cell therapy was presented (http://www.neostem.com/media/press-releases/news-item/neostem-presents-asco/). There has been over 20 years of experience investigating this therapy at this point. The toxicity data demonstrated no Grade IV (life threatening toxicity) and only one Grade III (allergic reaction attributed to the GM-CSF1) event in the pooled data. No significant adverse effects were reported regarding hematopoietic cells or renal function, hepatic function, or patient performance status. In addition the pooled survival data were also encouraging: For all patients 5 year survival with the treatment was 33%, which doesn’t sound great until you compare it to the 20% survival for control subjects. Furthermore the survival advantage was evident for all subgroups of patients. I hasten to point out that this observational evidence is no substitute for a properly conducted randomized controlled trial, but one can’t help but be a little curious about this novel approach
So wait a minute. Better survival, with less than traditional cancer-therapy levels of toxicity? Why haven’t you heard about this yet? Maybe this goes back to the “expectation” of toxicity for potent cancer therapies. This treatment is clearly not part of that paradigm.
NeoStem is here to change paradigms. During my first week at NeoStem, I started making phone calls to see what was happening with this technology, because I knew it had not yet advanced to a Phase 3 study. It just so happened that the trial was approved, but there was not yet funding for the work. So, simply put, and taking a page out of the old razor commercial, we liked the technology so much, we bought the company. We are delighted that the inventor of this therapy, Dr. Robert Dillman, is now the Vice Present of Oncology for NeoStem Oncology following the acquisition of California Stem Cell, now NeoStem Oncology. Dr. Dillman has championed this paradigm-changing approach to cancer therapy for over 20 yrs. In 2011 he formed a partnership with Dr. Hans Keirstead and the team at California Stem Cell to refine the manufacturing of the melanoma cell therapy. Together we are now poised to launch a randomized, controlled Phase 3 pivotal clinical trial of this therapy in 2014 which, if positive, could result in the approval of this treatment for advanced melanoma.
And this strategy isn’t limited to melanoma – it could be logically applied to many tumor types based on the stimulation of an aggressive response of each patient’s own immune system against the patient-specific tumor.
Can the oncology community come to accept a cancer therapy that isn’t toxic?? I’m pretty sure the patients can.
Read other blog posts by Dr. Douglas Losordo:
Forward Looking Statements
This blog contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this blog, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, the Company's ability to develop and grow its business, the successful development of cellular therapies with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's Immuno-oncology Program, Ischemic Repair Program, Immune Modulation Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry, and the performance and planned expansion of the Company's wholly-owned subsidiary and its center of excellence for cell therapy process development, engineering and manufacturing, PCT. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see the factors described under the heading, “Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K filed with the SEC on March 2, 2015 and those described in the Company's other periodic filings with the SEC. The Company undertakes no obligation to update or revise any forward-looking statements.
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