Here's something to cheer about, IMT fans:
IMUTEC PHARMA RECEIVES MARKETING APPROVAL FOR VIRULIZIN(R) FOR THE
TREATMENT OF MALIGNANT MELANOMA IN MEXICO
TSE/ME: IMT
NASDAQ: IMUTF
TORONTO, Oct. 21 /CNW/ - Imutec Pharma Inc. announced today that it has received approval for the marketing of Virulizin(R) from the SSA (Ministry of Health, Mexico) for the treatment of malignant melanoma in Mexico. The registration of Virulizin(R), which was based on the results of a multi-centre Phase II clinical trial of Virulizin(R), coordinated by the National Cancer
Institute of Mexico, represents the first product approval for Imutec Pharma.
"We are very pleased to be announcing this news today," said Mr.
Philippe G. Lacaille, President and Chief Executive Officer at Imutec Pharma. "There have been many challenges in the development of Virulizin(R) over the past several years, as there are with most new drugs. However, in spite of those challenges, we have persevered in its development because of our confidence in the safety and efficacy of the product." The Company further
reported that, based on the approval in Mexico, it expects to file in other countries for marketing approval of Virulizin(R) in the treatment of malignant melanoma while it continues its clinical program in the United States and Canada in other indications.
Malignant melanoma, the eighth most common form of cancer in North
America, is one of the deadliest of three main types of skin cancer - the other two are basal cell carcinoma and squamous cell carcinoma. If untreated, it is a disease which spreads to other areas of the body, primarily the lymph nodes, liver, lungs, bones and central nervous system. The incidence of malignant melanoma is rising in many countries at a rate of 7 percent each year, and the number of cases worldwide is expected to exceed 200,000 in 1998.
In a multi-centre Phase II clinical trial, completed under the
supervision of Dr. Jaime de la Garza, Director of the National Cancer
Institute of Mexico, patients with advanced malignant melanoma received treatment with Virulizin(R). The primary study objectives were to determine the effectiveness of Virulizin(R) in prolonging overall survival and improving patient quality of life. A marked improvement in each of these categories was demonstrated, and it was based on these results that the Company filed for product registration in November 1996.
"The standard treatment for malignant melanoma is still Dacarbazine (DTIC) which carries with it many side effects, including severe nausea and vomiting, and a potentially lethal side effect of acute liver necrosis," said Dr. Guy Ely, Vice President, Clinical and Medical Affairs at Imutec Pharma.
"However, the findings of our study demonstrated that Virulizin(R) represents an important therapeutic option for these patients. We believe the approval of Virulizin(R) for malignant melanoma represents a significant advance in the treatment of this fatal disease."
The Company's proprietary lead drug, Virulizin(R), is a potent and unique activator of human white blood cells called macrophages. Initial clinical investigations with Virulizin(R) have focused on advanced pancreatic adenocarcinoma, advanced malignant melanoma, HIV-related Kaposi's sarcoma and invasive cervical/uterine carcinoma. In patients diagnosed with advanced malignant melanoma, a 2-3-fold increase in the one-year survival rate was observed, in comparison with historical controls. Further, over the last eight
years, in over 450 patients throughout North America and Mexico, Virulizin(R) has demonstrated an excellent safety profile. Currently, Virulizin(R) is being tested in a Phase I/II clinical trial in the United States for the treatment of pancreatic cancer and a Phase I/II clinical trial in Canada for the treatment of HIV-related Kaposi's sarcoma.
"Up to this point, Virulizin(R) has been given to patients with
advanced, untreatable cancers in an attempt to extend survival and improve quality of life," said Mr. Lacaille. "Over time, our aim is to test Virulizin(R) in combination with chemotherapeutic agents in patients who have been diagnosed earlier in their cancer, and for whom greater benefits, including long term remission, are possible."
Imutec Pharma also reported that it anticipates signing a marketing agreement with a pharmaceutical partner for the distribution of Virulizin(R) in Mexico before the end of the year.
Imutec Pharma Inc. is a biopharmaceutical company engaged in the
research, development and commercialization of innovative pharmaceutical products for the treatment of cancer and certain viral diseases. Through an active acquisition and in-licensing program, Imutec Pharma's goal is to build and clinically develop a portfolio of innovative drugs targeted at life-threatening diseases. Thereafter, Imutec Pharma intends to undertake late stage clinical development and marketing in cooperation with strategic pharmaceutical partners. Founded in 1986, Imutec Pharma Inc. is a public company listed on the Toronto Stock Exchange and the Montreal Stock Exchange
under the symbol IMT and on the NASDAQ exchange under the symbol IMUTF.
Except for historical information, this press release contains
forward-looking statements which reflect the Company's current expectation
regarding future events. These forward-looking statements involve risks and
uncertainties which may cause actual results to differ materially from those
statements. Those risks and uncertainties include, 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 filings, annual reports and 20-F filings.
Imutec Pharma's press releases are available through the Company's
Internet site: imutec.com
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