CEL-SCI Corporation Commences Phase III Clinical Trial in Head and Neck Cancer in India

CEL-SCI Corporation announced that it has commenced its global Phase III clinical trial for Multikine^®, the Company's flagship immunotherapy, at the Meenakshi Mission Hospital and Research Centre in Madurai, Tamil Nadu, India, the first clinical site in India. Enrollment is expected to commence in the first half of May. Currently, the study has a US center at Hematology and Oncology Associates in Tupelo, Mississippi, actively recruiting patients. The Company expects enrollment in India to be substantially faster than in North America since head and neck cancer is India's leading cancer. The total study is expected to enroll a total of about 880 head and neck cancer patients in about 48 hospitals in 9 countries on three continents. CEL-SCI's partners Teva Pharmaceuticals and Orient Europharma will conduct parts of the Phase III study in Israel and Taiwan respectively.

The goal of this study is to establish Multikine as a first-line standard of care therapy in treating newly diagnosed, not yet treated head and neck cancer patients. The trial is believed to be the largest head and neck cancer study ever conducted and is called "IT-MATTERS", an acronym for: Immunotherapy Multikine Anti Tumor Treatments.

"We are very excited to begin this pivotal study in the first center outside of the US," said Geert Kersten, Chief Executive Officer of CEL-SCI. "We expect foreign centers to attract a significant number of patients, which will compress the time period necessary to complete the study."

CEL-SCI's Phase III clinical trial is an open-label, randomized, controlled, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for treatment naive subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus subjects treated with standard of care only. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. A detailed description of the study can be found at:http://www.clinicaltrials.gov/ct2/show/NCT01265849?term=multikine&rank=1.

Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of subjects, which are the patient population now being selected for the Phase III Study. This was achieved following 3 weeks of treatment, the same treatment regimen that is now used in the Phase III study. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumors before the start of standard therapy. Follow-up studies of subjects enrolled in the "proof of concept" Phase II trial showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery. The U.S. Food and Drug Administration granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.

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Karo Bio and Alkem Laboratories Ltd. Collaborate to develop Eprotirome

Karo Bio AB (publ) and Alkem Laboratories Ltd have entered into a collaboration and license agreement regarding eprotirome, currently in late-stage clinical testing for dyslipidemia. Karo Bio will grant Alkem rights to commercialize eprotirome in India and certain other countries. Alkem will participate in Karo Bio's phase III program for eprotirome by conducting a pivotal clinical study on eprotirome in India.

Karo Bio has entered into a collaboration and license agreement with the Indian pharmaceutical company Alkem Laboratories Ltd (Alkem). Under the agreement, Alkem will receive the exclusive rights to commercialize eprotirome in India and certain other markets in Asia-Pacific and Africa. Karo Bio is entitled to royalty on Alkem’s future sales of eprotirome.

Alkem will conduct a pivotal clinical phase III trial in order to obtain marketing approval of eprotirome in India. The clinical trial will comprise up to 500 patients with primary hyperlipidemia with a high risk for cardiovascular disease, mainly patients with previous cardiovascular events.

Data from the Indian study will be included in Karo Bio’s application for marketing approval of eprotirome for the treatment of high-risk patients with heterozygous familial hypercholesterolemia (HeFH) in the EU. Karo Bio’s phase III program for HeFH has previously been estimated to be an investment of SEK 400 million. As a consequence of the collaboration with Alkem, Karo Bio estimates that the investment will be reduced by approximately SEK 100 million.

“The benefits with the collaboration are several. Firstly, it represents a substantial financial value, since our investment in eprotirome’s phase III program will decrease from about SEK 400 million to SEK 300 million as a consequence of Alkem conducting one of the studies. Secondly, we secure distribution in the Indian market, as well as in a number of emerging markets. Finally, we facilitate a broadening of the indication scope of eprotirome, by conducting the study in India in patients representing a larger patient population” said Karo Bio’s President and CEO Fredrik Lindgren.

Eprotirome is a novel, liver-selective thyroid hormone receptor agonist for the treatment of dyslipidemia. The thyroid hormone is one of the body’s own ways of regulating lipids in the blood. This effect is exercised in the liver. Eprotirome’s profile is unique. In one single compound, powerful reductions of several independent risk factors for the development of atherosclerotic cardiovascular diseases are combined. Eprotirome has in three clinical phase II trials been demonstrated to, when administered either as monotherapy or on top of ongoing statin or ezetimibe treatments, produce a profound and clinically meaningful lowering of several important risk factors for the development of cardiovascular disease in patients with high blood lipids. The results are very encouraging, since many patients do not reach their treatment goals with current drugs.

Alkem is the 7th largest company in the Indian pharmaceutical market with leadership in anti-infectives, gastro intestinal and pain management segments. With over 500 products, Alkem is among the fastest growing companies in the Indian pharmaceutical market. Alkem is also focusing on strengthening its forays in the chronic segments of cardiology and diabetology. Headquartered in Mumbai, Alkem has international operations in both advanced and emerging markets with its products available in over 50 countries. Alkem has strong manufacturing capabilities in India with regulatory accreditations from agencies such as US FDA and UK MHRA for most of its manufacturing plants. Alkem currently has annual revenues of about USD 350 million dollars and a sound set of financials and cash reserves.

Dr. C.B.Sanjeevi at Karolinska Institutet and Invest Sweden assisted Karo Bio in establishing the partnership with Alkem.

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St. Renatus ready for Phase 3 trials for its needle-free anesthetic

St. Renatus LLC announced that the company had a favorable End of Phase 2 review with the U.S. Food and Drug Administration and will proceed with Phase 3 efficacy studies of its nasal mist dental anesthetic in the near future.

The Phase 2 clinical trial results submitted to the FDA indicated that the nasal mist is comparable to that of a standard needle-injected dental anesthetic, according to the company.

"We are very pleased with how the nasal mist has performed in trials thus far, and with the outcome of our meetings with the FDA, we believe it represents a significant step forward for both St. Renatus and the field of dentistry," said Steve Merrick, St. Renatus CEO.

Initial consumer research for the nasal mist product indicated that 90 percent of all patients were very likely or somewhat likely to choose the product over a needle-injected anesthetic.

Ninety-six percent of dentists surveyed said they expected to offer the nasal mist anesthetic when it becomes available, according to the company.

Phase 3 clinical studies required by the FDA are expected to be completed by the second half of 2011 with a new drug application likely to be filed in the latter part of 2011.

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First patient enrolled in second phase III clinical trial of Urocidin

Endo Pharmaceuticals and Bioniche Life Sciences Inc. announced enrollment of the first patient in the second phase III clinical trial of Urocidin. The trial is a randomized, active-controlled, open-label, multi-centre study with a blinded endpoint assessment designed to compare Urocidin with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle-invasive bladder cancer.

It is estimated that 450 patients will be enrolled for this new trial at approximately 120 clinical sites worldwide. Summary details of the study protocol are now publicly available via the US National Institutes of Health (NIH) clinical trial registration service at http://www.clinicaltrials.gov/.

In North America, bladder cancer is the fourth most common cancer in men and the fifth overall between both men and women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year and 500,000 living patients have been affected.

In Europe, more than 100,000 patients are newly diagnosed each year. Bladder cancer is frequently a recurrent disease, with some cases becoming refractory to available chemotherapeutic or immunotherapeutic agents and leading to cystectomy (bladder removal) or death.

Approximately 70 per cent of bladder cancer patients have the non-muscle-invasive form of bladder cancer. Collectively across the US, Europe and Japan, approximately 350,000 non-muscle-invasive bladder cancer patients are newly diagnosed or have a recurrence each year.

Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.

Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder. The agent is then able to directly interact with the cells of the immune system and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid by Bioniche from sales.

Endo holds exclusive global rights to develop and market Bioniche's patented formulation of Mycobacterial Cell Wall-DNA Complex (MCC), Urocidin(TM), being developed for the intravesical treatment of non-muscle-invasive bladder cancer.Under the licensing agreement, Bioniche received an up-front payment of US$20 million in July 2009, and became eligible to receive an additional US$110 million in milestone payments. Milestones are announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche provides clinical trial material and will also receive a net-sales-based revenue stream upon product approval.

Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs over 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety.

Endo Pharmaceuticals is a US-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics and aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology.

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