IMUC - Nice Letter to Shareholders & itty bitty float could get interesting
ImmunoCellular Therapeutics, Ltd. Issues Letter to Shareholders
8:30 am ET 05/26/2010- Business Wire
LOS ANGELES--(BUSINESS WIRE)-- ImmunoCellular Therapeutics. Ltd. or “IMUC” (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, issued the following Letter to Shareholders today:
Dear Shareholder:
I wanted to update you on ImmunoCellular corporate and industry developments over the past six months, since my last letter to you. Today, your company is very different than it was in mid-November. We have announced promising clinical results for ICT-107, our dendritic cell-based cancer vaccine which targets glioblastoma multiforme (GBM), the most prevalent, aggressive and malignant form of primary brain tumors, strengthened our balance sheet to fund a planned Phase II clinical trial of ICT-107 and seen a validation of immunotherapy as a treatment modality through Dendreon's FDA clearance. These developments have positioned IMUC to create significant shareholder value in 2010 and beyond.
Some of the recent highlights include:
Strengthened balance sheet. In the last three months alone, the Company has raised approximately $8.5 million. We will continue to manage our cash conservatively, which historically has resulted in cash consumption of approximately $650,000 per quarter. Of course, our cash expenditures will increase as we accelerate our clinical and other research and development activities, but we should now have sufficient working capital to initiate and complete patient enrollment forour Phase II trial for ICT-107 and to pursue other clinical programs.
Reported impressive Phase I results for ICT-107 in a GBM trial. The Company recently announced top-line results, which demonstrated a median progression free survival for patients who received the vaccine of 17.7 months. We will be presenting new data on 18 and 24-month disease free survival and overall survival, as well as the full results of the trial at the 2010 American Society of Clinical Oncology Annual Meeting in Chicago on June 6th. While this trial involved a limited number of patients, we believe that this data represents the most impressive results reported to date from any trial for a GBM vaccine.
Sought Orphan Drug Status for ICT-107. The Company submitted an application for orphan drug status for ICT-107 in May and anticipates approval within the next 90 days.
The Company recently entered into a sponsored research agreement and an option agreement with The University of Pennsylvania (“UPenn”) to support process development and manufacturing for the upcoming Phase II clinical trial of ICT-107. The UPenn agreement will include process optimization with the goal of increasing yields such that in a single manufacturing run enough doses could be produced for 2-3 years of each patient's vaccination and reduce the cost of manufacturing of each dose significantly. In addition, the optioned dendritic cell production technologies developed at UPenn could result in a higher potency as well as reduced time to manufacture these vaccines.
As part of our efforts to broaden the applications for our cancer vaccine technology platform, we have shown that our dendritic cell-based vaccination with cancer stem cells (CSCs) demonstrated a statistically significant survival benefit in a preclinical animal model of GBM. The rats were either immunized with cancer stem cells (CSCs) from a brain cancer tumor or the daughter cells (the bulk of the tumor), and results showed that those immunized with the CSCs had a median survival of 50 days compared to 29 days for daughter cells. 30% of the animals vaccinated against cancer stem cells demonstrated long term survival as compared to animals vaccinated with the bulk of the tumor, all of which died.
We also continue to develop other cancer vaccine programs. We recently reported that the Company and Torrey Pines Institute for Molecular Studies in San Diego, CA have identified several peptides which can generate CD-133 specific T-cells. CD-133 is found in high abundance on cancer stem cells (“CSCs”) which makes it promising for immunological targeting. The parties have extended their research agreement to pursue additional studies to support an Investigational New Drug Application (IND) filing for ICT-121, our “off the shelf” cancer vaccine candidate for GBM, and other solid tumor cancers, as well as research on other cancer stem cell targets such as Numb and Notch proteins which are expressed on CSCs. Additional pre-clinical studies are underway to support the IND filing, which we hope to make in late2010.
Our industry also made a significant achievement this year, in the announcement of the approval of Dendreon Corporation's prostate cancer vaccine by the FDA, which will result in the introduction of the first therapy utilizing the body's immune system to destroy tumors. The approval marks the first cancer immunotherapy product approved in the U.S., and we believe that it helps to validate immunotherapy treatments such as ours as a promising way to treat cancer. Our company is developing the next-generation of cancer vaccines by targeting multiple antigens and targeting cancer stem cells, widely held to be the root of most forms of cancer.
We are excited to present data at ASCO and to commence a Phase II trial in GBM this year to validate the promising results to date. We look forward to sharing these, and other corporate developments with our shareholders in the coming months.
Sincerely,Manish Singh, Ph.D.President and CEO
