While most companies base development and likelihood of success upon milestones, the biotechnology industry is especially reliant upon segmenting progressions. Much like mining, the path to commercialization is littered with obstacles and stringent government-related processes.
As a result, successfully completing any number of steps is highly regarded and strengthens the hope for success in years to come, which, of course, is judged by many smaller milestones in between.
Biotechs have their huge landmarks such as IND filings, clinical trial phases and New Drug Applications, but the road in between is broken down into smaller historic events, one of those being the issuance of patents to protect intellectual property.
While not typically garnering the breathtaking attention of the investment community that the larger milestones do, they carry a great deal of weight as far as the given biotechs infrastructure for success by preserving the concepts as their own. In all actuality, without the patent protection, many of the other progressions may never happen.
ImmunoCellular Therapeutics, Ltd. (OTCBB:IMUC), a Los Angeles, California-based junior biotechnology company focused on the development of novel immune-based cancer therapies, hit a patent milestone as announced this morning by the Company.
Patent No. 7,939,090 entitled "System and method for the treatment of cancer, including cancers of the central nervous system," was issued to the Company and covers the combination of a dendritic cell based vaccine combined either before or concurrently with chemotherapy at the recurrence of the disease.
ImmunoCellular holds the contention that treating cancer, particularly cancers of the central nervous system such as glioblastoma muliforme (GBM) can benefit substantially from dual therapeutic approaches. The Company is researching coupling a dendritic cell-based cancer vaccine with a regimen of chemotherapy which it believes can provide a substantial clinical benefit.
The Company’s contentions are not without merit as its Phase I clinical trial showed favorable outcomes. Phase I data from GBM treated with the combination of standard therapies (surgery, radiation, chemotherapy) and ICT-107, the Company’s dendritic cell based vaccine candidate as an indication for GBM, showed strong results with 16 patients showing a one-year overall survival of 100% and a two-year survival of 80%.
While historic medians without the combination therapy resulted in a progression free survival (PFS) of 6.9 months, the unique approach boosted the PFS to 16.9 months in the study. Moreover, 10 of the 16 patients (62.5%) are still surviving, well surpassing historic data of a 26.5% two-year survival rate of standard care alone.
Even more impressively, data shows six out of the 16 (37.6%) newly diagnosed patients who received ICT-107 continue to show no tumor recurrence, with three of these patients (18.8%) remaining disease-free for almost four years while the other three patients have gone more than two and a half years disease-free.
Is it a cure? Well, members of the biotechnology community are extremely cautious to never use the word "cure," especially this early in any research and with such a limited number of participants. But it is compelling data to support additional research, which is exactly what ImmunoCellular has planned.
The Company recently announced expansion of its Phase II trial of ICT-107 from up to 15 clinical centers to 20 or more. Patients are now being enrolled for the Phase II trial of ICT-107, a double-blind, placebo-controlled, 2:1 randomized study designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM.
Perhaps it is the patent news or it could be the repurposing of the clinical trial information in front of the investment community again which is spurring the value of a share of IMUC today.
A reason does not need to be discerned as the cost for a share of ImmunoCellular was pushing northward of $2; a rise of 11 cents, or 5.64%, with under an hour before Tuesday's closing bell.
