MONTREAL, Sept. 15 /CNW Telbec/ - Merck Frosst has announced today the approval in Canada of a first of its class in cancer treatment, (Pr)ZOLINZA(TM) (vorinostat capsules) for advanced CTCL (cutaneous T-cell lymphoma), a rare form of non-Hodgkins lymphoma which affects mainly the skin. The launch of ZOLINZA(TM) (vorinostat capsules) is part of the Merck Frosst commitment to the development of products to prevent cancer, to treat cancer and to provide supportive care to cancer patients.
Living with cancer is very difficult. Imagine living with a cancer that can manifest itself with visible proof of the pain of living with it - scaly skin, rashes, skin tumours and unbearable itching. That is the reality of a slow-progressing cancer called CTCL that affects approximately 4,000 Canadians. Although it may take years to be diagnosed, the slow progression of CTCL means that many patients can be diagnosed at the early stages.
"CTCL is a difficult condition to diagnose and because of that there may be a delay and at the end of the delay the patient is told they have lymphoma; that they have cancer," said Dr. Neil Shear, head of dermatology at the University of Toronto. "For some patients, it's all over their body like they've been tarred and feathered and they suffer horribly. They are itchy all over, their skin gets infected, it's cracked, it's fissured. They can't use their hands to do simple daily activities. It can be the most miserable condition."
These Canadians now have a new treatment option called ZOLINZA(TM) (vorinostat capsules), which is the first of a new generation of targeted treatments for advanced CTCL. ZOLINZA(TM) (vorinostat capsules) helps to improve the appearance of skin symptoms and as a result may help to reduce the burden that these patients experience daily from the physical, social, and emotional impacts of CTCL.
"ZOLINZA(TM) (vorinostat capsules) is a new type of anti-cancer drug which is very different from chemotherapy which just kills cancer cells. This treatment tells them to behave differently," said Dr. Eugenia Piliotis, a Toronto haematologist-oncologist and assistant professor of medicine at the University of Toronto. "Patients who respond well to ZOLINZA(TM) (vorinostat capsules), get dramatic improvements in the two most troublesome parts of this disease. One is intractable itch which can be quite limiting and the other is disfiguring skin lesions which often trap people in their homes."
ZOLINZA(TM) (vorinostat capsules) targets and decreases the activity of certain types of HDAC (histone deacetylase) enzymes to allow for the activation of genes that may help to slow or stop the growth of cancer cells to provide effective improvement of the skin symptoms of CTCL which can be itchy and painful.
"CTCL is such a difficult cancer to live with because it can be very painful - both physically and emotionally. It's visible and so very often patients don't leave their homes and people shrink away from them, afraid that they'll catch it. It's isolating at a time when people most need support," said Christine Jackson, Executive Director, Canadian Skin Patient Alliance. "We welcome this new treatment option and hope provincial drug plans move quickly to approve reimbursement so cost won't be a barrier to patients who could benefit from the treatment. People with CTCL suffer enough. They shouldn't have to wait to have a chance to get some relief - to be able to live functional lives again."
About cutaneous T-cell lymphoma (CTCL)
Cutaneous T-cell lymphoma (CTCL), a form of non-Hodgkin's lymphoma, is a rare type of cancer which affects mainly the skin and may cause debilitating, painful symptoms and severe impact on the quality of life. It is caused by the uncontrolled growth of a type of white blood cell within the skin called a T-cell. It generally has a slow progression, developing gradually over many years.
Its visible manifestations typically begin as scaly, red or dark patches on the skin, eventually forming plaques and bumps or tumours on the skin that may be itchy and painful and may worsen to become ulcerated and infected as the disease advances. They can be substantial in size, unpleasant and unsightly, resulting in important implications on appearance and adverse effects on quality of life. In advanced stages of the disease, CTCL can also affect the blood, lymph nodes and other internal organs. The initial changes to the skin may be similar to several other non-cancerous skin conditions such as eczema, psoriasis or allergies, but diagnosis of skin lymphoma cells is improving as new techniques are developed.
There is no cure for CTCL but with appropriate treatment patients can live relatively normal lives without serious, health-compromising complications. The prognosis for persons with CTCL depends on the stage of their disease at diagnosis. Those diagnosed at the earliest stage have a median survival of 20 or more years and are not likely to die of their disease, but more than half of those diagnosed in the more advanced stages die from the disease, with a median survival of less than five years. A common cause of death is sepsis caused by chronic skin infections.
Approximately 4,000 Canadians have CTCL (all disease stages) and approximately 300 new cases will be diagnosed in Canada this year. An estimated 250 Canadians have aggressive CTCL (stages IIb to IVb).
ZOLINZA(TM) (vorinostat capsules) constitutes an important treatment advance for CTCL. It is approved for the treatment of cutaneous manifestations in patients with advanced CTCL who have progressive, persistent or recurrent disease subsequent to prior systemic therapies. ZOLINZA(TM) (vorinostat capsules) is a once-a-day oral treatment, administered on an out-patient basis.
It is the only oral anti-tumour treatment approved for advanced cutaneous manifestations of CTCL. ZOLINZA(TM) (vorinostat capsules) provides effective improvement of the appearance of skin symptoms of CTCL, with progressive, persistent or recurrent disease subsequent to prior systemic therapies with a median time to response of less than two months. In patients with Stage IIB and higher CTCL, an overall objective response rate of 29.5% (18/61) was observed in the pivotal study.
In those patients who presented with pruritus (score of 3 or more) at the beginning of the trial, nearly one third (30%) of patients treated with ZOLINZA(TM) (vorinostat capsules) experienced pruritis relief, a condition that is extremely difficult to treat. In patients with advanced stage CTCL, 11% (6/53) had complete resolution. Improvement of pruritus was noted in both responders and non-responders.
There are no clinical data suggesting that ZOLINZA(TM) improved survival rates of patients with CTCL.
ZOLINZA(TM) (vorinostat capsules) is generally well tolerated, and the most common adverse events included fatigue, diarrhea, nausea, taste alteration and decrease in platelet count.
About the Canadian Skin Patient Alliance
Founded in 2007, the Canadian Skin Patient Alliance (CSPA) provides education, information, an online supportive community, and opportunities to create and join local support groups for all Canadian skin patients. CSPA is a patient-centered organization serving patient needs to enhance care, to promote skin health and to find cures for Canadian skin patients. CSPA also provides physicians and researchers access to patients and their concerns regarding skin disease. For more information, visit www.canadianskin.ca.
About Merck Frosst Canada Ltd.
At Merck Frosst, patients come first. Merck Frosst Canada Ltd. is a research-driven pharmaceutical company discovering, developing and marketing a broad range of innovative medicines and vaccines to improve human health. Merck Frosst is one of the top R&D investors in Canada, with an investment of close to $83 million in 2008. More information about Merck Frosst and ZOLINZA(TM) is available at www.merckfrosst.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2008, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
ZOLINZA(TM) is a Trademark of Merck & Co., Inc. Used under license
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