To: Biomaven who wrote (2893 ) 2/12/2001 12:21:04 AM From: Scott H. Davis Respond to of 52153 While I still need to allocate some material time to looking at the future revenue potential, I still continue to see methodical clinical progress with no public setbacks for VICL. I reviewed the following two releases and find several positive items. 1. Continued good safety profile, so dosing may now be increased, and injected into multiple sites. 2. Clearance to work with earlier stage patients. This should allow the opportunity to show greater efficacy, since this immune therapy will now be given to patients before cytotoxic compromized immune systems. Ultimately they have a reasonable chance at 1st line therapy, and the good safty profile should make combinational therapy an option. 3. Working positively with the FDA. In 4 years now, I don't remember VICL ever having any problems with the FDA in any of their trials. 4. They continue to expand the indications. Please, if I'm missing something, please let me now. I'm finding myself placing increasing value on the totality of my VICL observations - broadening indications, broadening technology platform with accompanying patents, low burn rate, no bad news - no programs cancelled, no partnerships ended, but rather expanded. No PR hype. Comes across to me as a very well managed company. How does once objectively value good management, or complete absence of bad news associated with any of their pregrams? Would really welcome input. Thanks, Scott Vical Begins Phase II Trial With Allovectin-7(R) in Oral Cancer SAN DIEGO, Feb. 8 /PRNewswire/ -- Vical Incorporated (Nasdaq: VICL - news) announced today the initiation of a multi-center Phase II trial with Allovectin-7® in up to 25 patients scheduled for surgical treatment of early-stage cancer of the oral cavity and oropharynx. Patients will receive two doses of Allovectin-7® followed by surgical intervention. The primary goal in the trial is reduction in tumor size prior to surgery. Additional objectives include assessment of the immune response to Allovectin-7®, safety, and analysis of the time to disease progression. Vical has conducted several trials with Allovectin-7® in patients with recurrent or persistent head and neck cancer that could not be cured by surgery. Previously reported results of those trials indicated that the treatment was safe and well-tolerated, and that patients who responded experienced rapid tumor reduction. The safety and response profile allowed the design of the new trial, which will measure tumor reduction over a three-week period prior to surgery. Allovectin-7®, which is designed to invoke an immune response against cancer cells, is expected to work better in earlier-stage patients with more functional immune systems. Responses in previous trials may have been limited by immune system suppression resulting from prior treatments and by the advanced stage of the cancer. Vijay B. Samant, Vical's President and Chief Executive Officer, said, ``Allovectin-7® has been used with some success in a variety of solid tumors in patients with advanced metastatic disease. We are excited by the prospect of treating patients with earlier-stage disease, who logically would have a better chance to respond. The fact that we saw partial and complete remissions in our previous trials offers great encouragement for the current trial.'' Vical Incorporated (Nasdaq: VICL - news) announced today the initiation of a multi-center Phase II Allovectin-7® trial in up to 80 patients with late-stage metastatic melanoma to refine the use of Allovectin-7® in clinical practice should it gain marketing approval from the U.S. Food and Drug Administration (FDA). Previous trials have used very low (10 ug) doses of Allovectin-7® delivered to a single tumor lesion. Allovectin-7®'s current safety profile allowed the company to design this new trial to test higher doses (up to 2 mg, a 200-fold increase) of Allovectin-7®, and delivery to multiple tumor lesions. Vical also announced today the completion of enrollment in its Phase II Allovectin-7® registration trial for patients with late-stage metastatic melanoma. Initial results from the trial were presented in May 2000 at the annual meeting of the American Society of Clinical Oncology. Updated results are expected in the second quarter of 2001. The company's Phase III Allovectin-7® registration trial continues to enroll patients with newly diagnosed metastatic melanoma at more than 40 clinical sites nationwide. Vical has scheduled a meeting with the FDA to discuss the Phase III trial status and review options for completion of the trial. Vijay B. Samant, Vical's President and Chief Executive Officer, said, ``We were encouraged by the early responses in our Phase II trial as reported last May, and we look forward to providing an update in the second quarter of 2001. Our top priority remains overcoming the challenges of patient recruitment while maintaining rigorous implementation of our FDA-allowed Phase III protocol, and we are making progress toward that goal. Meanwhile, our new Phase II trial should provide insights into broader applications of Allovectin-7®.''