Bioniche Life Sciences Inc. Announces North American Market Launch of Immunocidin(TM)
-ImmunocidinTM launched at Veterinary Cancer Society conference in Las Vegas, Nevada-
BELLEVILLE, ON, Oct. 17, 2012 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that its ImmunocidinTM canine oncology therapy is being launched in North America at the annual Veterinary Cancer Society conference. The conference takes place from October 18th-21st in Las Vegas, Nevada.
ImmunocidinTM is based on the Company's proprietary mycobacterial cell wall technology, the same platform from which its Phase III product for human bladder cancer (UrocidinTM) was derived. ImmunocidinTM is indicated as an immunotherapy for the intratumoral treatment of mixed mammary tumor and mammary adenocarcinoma in dogs. The product has received regulatory approval in Canada and the U.S. It is available now in the U.S. and will be available in the near future in Canada.
A recent survey of U.S. veterinarians conducted on behalf of the Company showed that mammary carcinoma is the 3rd most common cancer treated in the last 12 months by the respondents, with an average of 2.1 cases per month. Respondents reported to confirm an average of 19 cases of canine cancer each month, or approximately 8% of their total canine patient base. About two-thirds of these cancer cases are being treated in-house. About one-third of the cases are referred (whether or not they were initially treated in-house). On average, more than 18% of cases receive some form of chemotherapy, either alone or in conjunction with surgery. A number of limitations were identified around the use of chemotherapy, including lack of capability of handling such drugs in the clinic, lack of owner willingness to have the therapy used on their pet(s), and excessive cost of chemotherapy.
"We are excited to be entering the canine oncology market in North America," said Mr. Andrew Grant, President, Bioniche Animal Health (global). "We believe there is a tremendous opportunity for a product like ImmunocidinTM that does not require special handling and can be used by veterinarians in their own clinics, either alone or in combination with other therapies."
About Canine Cancer
Canine cancer is the leading disease-related cause of death in dogs, with approximately one in four dying of cancer.
Where a treatment is used in dogs with cancer, it can involve surgery, radiation therapy or chemotherapy. Radiation therapy is difficult to access and chemotherapy is highly toxic, requiring handling by specially trained personnel, which many companion animal veterinary clinics do not have. These therapies have similar side effects in animals as in humans (anorexia, nausea, hair loss, anemia, major infections, etc.) and can vastly diminish the dog's quality of life. Surgery and therapy costs for dogs with cancer can range from $3,000 to $15,000 and above, depending upon type and stage of cancer, number and type of primary and supportive treatments required, the age and condition of the dog, and the location of treatment (travel costs).
Second Bioniche Canine Cancer Therapy - OncocidinTM
The second canine oncology product will be OncocidinTM. Through the course of development of UrocidinTM for human bladder cancer, the mycobacterial cell wall technology was extensively tested in a number of human cancer cell lines, including bladder, ovarian, colon, gastric and breast, as well as in canine cancer cell lines, including osteosarcoma and mammary carcinoma, where it was shown to possess direct anticancer activity with apoptosis (programmed cell death) in cancer cells. The technology has also been demonstrated to be synergistic with chemotherapeutic agents. Further, a large amount of toxicity work has been completed to ascertain the product's safety for human use. One of the safety studies involved a number of dogs in an intravenous (I.V.) safety study, required to support the Phase III UrocidinTM program and to support registration. After multiple I.V. administrations of high doses of the product in the dogs, it was demonstrated that the product is safe and the safety profile was satisfactory to regulatory agencies.
This work has led to further analysis of an I.V. therapy for canine cancer based on the same technology. Chemotherapy treatment commonly causes cytopenia, a deficiency in the number of cellular elements in the blood, specifically, neutrophils.
Most recent experimental studies show that a single dose of OncocidinTM following chemotherapy treatment in healthy dogs restores the number of white blood cells in the dog to normal levels within 24 to 48 hours after treatment. The Company is undertaking dose confirmation studies prior to conducting final licensing studies. It is anticipated that this work will be completed by mid-2013, after which regulatory approvals will be sought, first in North America, then in Australia and Europe.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary and innovative products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop and commercialize products that advance human or animal health and increase shareholder value.
Bioniche Animal Health develops, manufactures and markets veterinary biopharmaceutical products worldwide. In North America, it has development, manufacturing and marketing facilities in Belleville, Ontario, Canada, Athens, Georgia, U.S.A. and Pullman, Washington, U.S.A. In Australia, business is conducted from two sites: Sydney, New South Wales, where sales and marketing, customer support and technical service are located; and Armidale, New South Wales, where research, development and manufacturing facilities are located.
For more information, please visit www.Bioniche.com.
Except for historical information, this news release may contain
forward-looking statements that reflect the Company's current
expectation regarding future events. These forward-looking statements
involve risk and uncertainties, which may cause, but are not limited
to, changing market conditions, the successful and timely completion of
clinical studies, the establishment of corporate alliances, the impact
of competitive products and pricing, new product development,
uncertainties related to the regulatory approval process, and other
risks detailed from time to time in the Company's ongoing quarterly and
SOURCE Bioniche Life Sciences Inc.