Frost & Sullivan Names YM BioSciences 2004 Breast Cancer Therapies Entrepreneurial Company of the Year.Business Editors/Health/Medical Writers PALO ALTO, Calif.--(BUSINESS WIRE)--May 5, 2004 In its recent study, entitled "U.S. Breast Cancer Therapeutics Market," Frost & Sullivan found that YM BioSciences (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :YM) (AIM:YMBA YMBA Young Men's Buddhist Association ) is the entrepreneurial leader in developing its novel late-stage cytotoxic-enhancing compound, which will potentially enhance tactics to fight the continuing war against cancer. YM BioSciences' pipeline focuses on novel therapeutics that principally target advanced solid tumor indications such as metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. breast cancer, prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. , head and neck cancer, and NSCLC NSCLC non (or cancer). NSCLC Non-small cell lung cancer, see there . The Canadian drug development company is unique in that it conducts no discovery research. Its business development strategy focuses on in-licensing promising technology for its product development portfolio. The company's lead product is a novel chemopotentiator known as tesmilifene or DPPE DPPE Device Power Policy Engine (diethyl-2-(4-(phenylmethyl)phenoxy)ethanamine) that has demonstrated a large effect on survival in patients with metastatic breast cancer, making it a significant factor in late-stage breast cancer cytotoxic therapy. Few other drug candidates have demonstrated such a positive survival benefit as this compound. The first international Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the for the compound, conducted by the National Cancer Institute of Canada, demonstrated a more than 50 percent survival benefit for patients receiving tesmilifene in combination with doxorubicin doxorubicin /doxo·ru·bi·cin/ (dok?so-roo´bi-sin) an antineoplastic antibiotic, produced by Streptomyces peucetius, which binds to DNA and inhibits nucleic acid synthesis; used as the hydrochloride salt and as a liposome-encased , compared to doxorubicin alone. "These results are significant because developments in chemotherapeutic treatments over the past two decades focus on enhancing the quality of life, whereas the more important indicator of therapeutic potential is increased survival," says Frost & Sullivan industry analyst Curt Herberts. "Therefore, the development of a compound that acts synergistically syn·er·gis·tic adj. 1. Of or relating to synergy: a synergistic effect. 2. Producing or capable of producing synergy: synergistic drugs. 3. with already approved chemotherapy agents has the potential to radically augment the treatment of metastatic disease." YM BioSciences initiated the second Phase III clinical trial of tesmilifene on March 31, 2004 to assess its effects in combination with epirubicin and cyclophosphamide cyclophosphamide /cy·clo·phos·pha·mide/ (-fos´fah-mid) a cytotoxic alkylating agent of the nitrogen mustard group; used as an antineoplastic, as an immunosuppressant to prevent transplant rejection, and to treat some diseases compared to the two cytotoxic agents alone for treating metastatic breast cancer. The registration trial drug is subject to a positive Special Protocol Assessment by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and to a Sequential Analysis that permits the trial's Data Monitoring Board to review the data at any time in order to assess the statistical significance for a New Drug Application. A positive outcome from this analysis would significantly shorten the trial length and the number of patients required in the trial. For its entrepreneurial success with in-licensing and developing a novel potentiator compound, organizing multiple late-stage clinical trials, and negotiating favorable and unusual "Sequential Analysis" terms with the FDA, YM BioSciences is the recipient of Frost & Sullivan's 2004 Breast Cancer Therapies Entrepreneurial Company of the Year Award. Frost & Sullivan presents this award to the company that has demonstrated superior entrepreneurial ability in its industry. It signifies the company's identification of a unique and revolutionary product solution with significant market potential. Additionally, the award certifies that the company's marketing strategy is sound and poised for success. Tesmilifene is well ahead of other competing technologies, and if approved, it will not require oncologists to alter their existing treatment regimens because the compound potentiates existing chemotherapy drugs. These end-user cooperative qualities enhance the great likelihood that tesmilifene can gain regulatory approval with the uptake challenge by oncologists being minimized. About YM BioSciences Inc. YM BioSciences Inc. is a cancer drug development company. Its lead drug, tesmilifene, is a small molecule chemopotentiator (for taxanes and anthracyclines) that has recently been cleared by the FDA for a pivotal Phase III in metastatic breast cancer, which was initiated in Q1 2004, and for which it had completed a Phase III trial with positive results. In addition to tesmilifene, the company is developing an EGFr humanized monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing that has completed the Phase II trials and a GnRH anti-cancer vaccine that is in earlier stages of clinical trials. YM BioSciences is also supporting the pre-clinical development of two additional cancer products. About Frost & Sullivan Founded in 1961, Frost & Sullivan is recognized as a global leader in growth consulting. Frost & Sullivan Awards are presented to companies that demonstrate excellence in their industry through diligence, commitment and innovative business strategies that are required to advance in the global marketplace. Frost & Sullivan rigorously analyzes specific criteria to determine award recipients in a vast variety of market industries and landscapes. For further information, visit www.frost.com. NOTE TO EDITORS: In the above term, (diethyl-2-(4-(phenylmethyl)phenoxy)ethanamine), there should be brackets before "4" and after "phenoxy." Parentheses See parenthesis. parentheses - See left parenthesis, right parenthesis. were used for transmission purposes only. |
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