CEL-SCI Corporation Releases Letter to Shareholders
Monday July 28, 9:20 am ET
VIENNA, Va., July 28 /PRNewswire-FirstCall/ -- Geert Kersten, Chief Executive Officer, and Maximilian de Clara, President, both of CEL-SCI CORPORATION (Amex: CVM - News), sent the following letter, dated July 28, to the company's shareholders:
As many of you know, CEL-SCI was established to develop better medicines against cancer. We developed our non-toxic immunotherapy drug Multikine® because it offered a way to stimulate a comprehensive immune response against the cancer. The promise of this drug kept us going through the years and we have been very pleased with our clinical results. We have now discovered that Multikine has an application far beyond our original expectations, namely as a way to enhance radiation and chemotherapy.
In July 2003, a leading peer-reviewed cancer journal accepted for publication data from our Phase I/II clinical trial showing that Multikine treatment of cancer patients prior to surgery renders the remaining cancer cells highly susceptible to follow-on radiation/chemotherapy. This new finding is one of the most significant advances for CEL-SCI to date because radiation and chemotherapy are the mainstays of cancer therapy. Just think of the implications! Every radiation/chemotherapy treatment could some day possibly be enhanced through pre-treatment with Multikine.
Current conventional treatment for head and neck cancer and other solid tumors usually consists of surgical intervention (when possible) to remove the bulk of the tumor, followed by radiation, chemotherapy, or a combination of radiation and chemotherapy. The problem doctors face is two-fold. First, the tumor is usually surrounded by tumor micro-metastasis (small groupings of cancer cells) that cannot be seen by the surgeon. If surgery misses them, the patient's cancer will most likely recur. Second, the radiation and chemotherapy following surgery are administered to kill those remaining tumor cells, but most of those remaining tumor cells are not susceptible to radiation and chemotherapy. For this reason, radiation and chemotherapy are given repeatedly to patients, however, these treatments still do not cure as many of the patients as we would like to see.
We believe, based on the clinical data now in publication, that the strong immune response following Multikine administration kills a large number, and in some cases, all of the remaining tumor cells that are principally responsible for the recurrence of cancer. Any remaining cancer cells will be more susceptible to treatment with radiation/chemotherapy as a result of pre- treatment with Multikine. We believe that the combination of these two achievements by Multikine pre-treatment of the cancer should significantly reduce the recurrence rate of the patients. Indeed, in one Multikine head & neck cancer study, none of the first 8 sequentially treated patients at one center had a recurrence of the cancer 24 months following surgery. While this information does not provide statistical proof, it provides important support because the recurrence rate of head & neck cancer patients not pre-treated with Multikine at 24 months after surgery is close to 50%. Recurrence is to be avoided at all cost as many of the recurrent patients die of the disease.
At the beginning of the year, we listed a number of milestones for CEL- SCI. We have achieved everything that we had hoped to achieve by the summer. Three grants, totaling $1.4 million, from the U.S. Government for our products were awarded in the spring. One partnering deal was signed and we are working on others. Our key paper on the new mechanism of action of Multikine to enhance radiation/chemotherapy was accepted for peer-reviewed publication. We are hopeful that publication will occur this year.
During the past few weeks, we have met with many analysts and fund managers who were very interested in the results of our paper. Historically, publication of significant data in peer-reviewed publications has been the way to attract the attention of the analysts and fund managers.
We are also working on the Phase III clinical trial application to FDA for Multikine. Multikine is regulated as a complex biologic and, as such, the emphasis on manufacturing is even greater. We have already submitted our manufacturing amendments to the FDA.
We are currently evaluating how we can best use our new finding with Multikine in new clinical trials. Our goal is to focus on the fastest way of getting Multikine approved for sale. Subsequently, we would use the revenue from sales to expand the approval to other cancer indications. We are hopeful that we can achieve the goal we started with, to develop a better medicine against cancer. We thank you for your support. |
