Last week, several companies within our coverage universe released financial results and corporate updates, including CEL-SCI Corporation (CVM-NYSE Amex), Pro-Pharmaceuticals Inc. (PRWP-OTC), and Advaxis Inc. (ADXS-OTC). In addition, Neuralstem, Inc. (CUR?-NYSE Amex)? announced a breakthrough in its clinical trials that it believes could greatly influence the treatment of amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease—a potentially fatal neuromuscular disorder.
CEL-SCI Reports Quarterly Results
On February 10, 2011, CEL-SCI released financial results for the quarter ended December 31, 2010. In addition, CEL-SCI reported an increase in R&D spending, which was directly related to the start of its Phase III clinical trial of Multikine®, a novel immunotherapeutic agent for head and neck cancer, in December 2010. Operating loss for the fiscal quarter ended Dec. 31, 2010, stayed relatively even at roughly $4.32 million versus $4.25 million at Dec. 31, 2009. As of December 31, CEL-SCI had cash, cash equivalents, and prepaid expenditures of $23 million.
CEL-SCI seeks to position Multikine® as a new standard-of-care treatment for newly diagnosed head and neck cancer patients. The currently ongoing clinical trial is expected to enroll up to 880 patients, making it one of the largest clinical studies of head and neck cancer ever conducted. To CEL-SCI’s knowledge, this Phase III study is also the first trial where immunotherapy is administered before any other traditional means of cancer care, including surgery, chemotherapy, and radiation. Additionally, CEL-SCI develops treatment vaccines directed against H1N1 (swine) influenza, other viruses and infectious diseases, as well as parasitic diseases and autoimmune diseases, such as rheumatoid arthritis and myocarditis.
Pro-Pharmaceuticals Raises over $5 Million
Last Thursday, Pro-Pharmaceuticals announced that it received a $234,000 installment of the $489,000 in funding from a federal grant. This grant was filed under the Qualifying Therapeutic Discovery Project (QTDP). QTDP grants are only offered to companies with less than 250 employees that are focused on the treatment, prevention, diagnosis, or development of products for existing diseases. In filing for the federal grant, Pro-Pharmaceuticals submitted two applications, including one for DAVANAT®, an anti-cancer compound for colorectal cancer that is entering a Phase III clinical trial. The second application was related to its GR and GM series of anti-fibrotic, cirrhosis compounds, which have shown to reverse fibrosis and cirrhosis in preclinical studies. Presently, the only possible treatment for fibrosis and cirrhosis is a liver transplant. Pro-Pharmaceuticals also announced that it raised over $5 million in equity transactions, resulting in a current cash position of approximately $8.1 million, which may fund core operations into the second half of 2012.
Advaxis Reports FY 2010 Financials
On February 7, 2011, Advaxis announced financial results for the fiscal year ended October 31, 2010. Advaxis’ gross revenues for the year were $508,500. The increase related to a federal grant in addition to the sale of prior years’ net operating losses through a New Jersey Economic Development Authority program. R&D expenses increased in 2010 over the prior period in 2009 due to two company-funded, Phase II clinical studies in cervical cancer and cervical dysplasia initiated in the U.S. and in India. Net loss for the fiscal year was $10.8 million versus a net income of $0.9 million for fiscal 2009. Advaxis reported cash and cash equivalents of $108,000 as of October 31, 2010. In 2011, the company plans to announce new clinical data and add two new Listeria-based constructs to its clinical initiatives, among other objectives.
Neuralstem Advances its Phase I Trial
On February 10, 2011, Neuralstem provided updates for its ongoing Phase I clinical trial of spinal cord stem cells in the treatment of ALS. After examining safety data from the first nine patients, the trial’s Safety Monitoring Board undisputedly approved going forward to the last group of ALS patients in this part of the safety trial. The next three patients, all of whom are able to walk, may receive 10 injections, bilaterally, in the lumbar spinal cord. After this study, Neuralstem expects the FDA to analyze the trial data before making any decisions in moving forward into the final patient cohort. Individuals involved in the final study may receive injections in the cervical area of the spinal cord.
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CEL-SCI Corporation (CVM-NYSE Amex) is advancing its Phase III clinical trial of Multikine®, CEL-SCI’s lead immunotherapy product. Multikine® is being developed as a first-line standard-of-care treatment for head and neck cancer. In previous Phase II trials, this therapy was safe and well-tolerated, and had increased patient survival by 33% at a median of 3.5 years after treatment. Multikine® was also credited with eliminating head and neck cancer tumors in 12% of patients less than a month into treatment. On average, CEL-SCI’s new cancer therapy kills about 50% of tumor cells before patients have surgery or begin chemotherapy, which improves the likelihood of success of these standard treatments.
Throughout September and October 2010, CEL-SCI has been receiving IRB approvals to commence the global Phase III trial of Multikine® needed to pursue regulatory approval. North Mississippi Health Services in the U.S. has approved patient enrollment for the study, as has an IRB in Taiwan, the Hungarian National Institute of Pharmacy, and the Ethical Council Affiliated with the Ministry of Healthcare and Social Development of the Russian Federation. Altogether, the trial is targeted for nine countries and CEL-SCI expects it to be the largest clinical study of head and neck cancer ever conducted.
CEL-SCI has announced that it is holding a Biotech, Pharma, and Healthcare Virtual Conference today via webcast at 11:30 am ET. Visit http://www.investorcalendar.com/IC/ClientPage.asp?ID=161779&CID to participate, and http://www.investorcalendar.com/ClientPage.asp?ID=161779 for a replay.