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CYTOGEN LAUNCHES SOLTAMOX ORAL LIQUID FOR BREAST CANCER.


Cytogen Corporation, Prineton, N.J. has announced that SOLTAMOX(tm) (tamoxifen citrate tamoxifen citrate (tmok´s , oral solution 10mg/5mL), the first liquid form of the hormonal breast cancer therapy tamoxifen tamoxifen (təmŏk`sĭfĕn'), synthetic hormone used in the treatment of breast cancer. Introduced in 1978, tamoxifen is used to prevent recurrences of cancer in women who have already undergone surgery to remove their tumors. , is currently being introduced in the United States and is available in U.S. pharmacies nationwide. SOLTAMOX received U.S. Food and Drug Administration marketing approval in October 2005 and is indicated for the treatment of 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 and to reduce the incidence of breast cancer in women who are at high risk for the disease. The Gail Model Risk Assessment Tools will be available from Cytogen to aid in accessing risk.

"Cytogen is extremely pleased to be bringing this important alternative treatment option to patients across the country who are affected by breast cancer or who are at risk for developing the disease," said Michael D. Becker, president and chief executive officer of Cytogen.

Difficulty swallowing, a condition called dysphagia dysphagia /dys·pha·gia/ (-fa´jah) difficulty in swallowing.

dys·pha·gia or dys·pha·gy
n.
Difficulty in swallowing or inability to swallow.
, is a common complication of cancer therapy, resulting in particular from treatment involving radiation or chemotherapy. Cancer patients with dysphagia experience problems swallowing pills due to mouth and throat sores, inflammation or dry mouth. To address this problem, many patients resort to cutting or crushing drugs administered in pill form. This can lead to risks including altered dosing efficacy or side effects Side effects

Effects of a proposed project on other parts of the firm.
 associated with improper dosing. In addition, patients with dysphagia may be less likely to comply with prescribed regimens because swallowing is difficult or painful.

As with other versions of tamoxifen, the SOLTAMOX product label also includes a black box warning with information on the potential risk of adverse events. The boxed warning states that: "Serious and life threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with ductal carcinoma in situ ductal carcinoma in situ Intraductal carcinoma, DIN 3 Surgical oncology A localized form of breast CA, in which malignant cells are confined to the duct wall; DCIS has a heterogeneous biologic behavior and morphology, and is detectable by mammography Epidemiology ) include uterine malignancies, stroke and pulmonary embolism Pulmonary Embolism Definition

Pulmonary embolism is an obstruction of a blood vessel in the lungs, usually due to a blood clot, which blocks a coronary artery.
."

Full prescribing information for SOLTAMOX is available on Cytogen's Web site at http://www.cytogen.com.

Cytogen has exclusive marketing rights for SOLTAMOX in the United States under a distribution agreement. SOLTAMOX is a trademark and the product is also licensed in the United Kingdom, Ireland and Germany.

About Breast Cancer

Breast cancer is the most common non-skin cancer in women and the second leading cause of death in women after lung cancer. An estimated 212,920 women in the United States will be diagnosed with breast cancer in 2006, according to the American Cancer Society American Cancer Society,
n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research,
. Currently, more than two million women in the United States have been treated for breast cancer. The chance of a woman having invasive breast cancer during her life is about 1 in 8. Estrogen is known to promote the growth of approximately two-thirds of breast cancers that contain estrogen or progesterone receptors. Breast cancer treatment This article or section recently underwent a major revision or rewrite and needs further review. You can help!

The mainstay of breast cancer treatment is surgery when the tumor is localized, with possible adjuvant hormonal therapy (with tamoxifen or an aromatase
 often involves agents designed to block the effect of estrogen or lower estrogen levels. Tamoxifen, the most commonly used anti-estrogen drug, has been shown to reduce the risk of cancer recurrence and improve overall survival in all age groups.

About SOLTAMOX

SOLTAMOX is a sugar-free, clear colorless liquid, with licorice licorice (lĭk`ərĭs, –rĭsh), name for a European plant (Glycyrrhiza glabra) of the family Leguminosae (pulse family) and for the sweet substance obtained from the root.  and aniseed odor and taste. It is supplied in a 150mL bottle. Each 5mL dose contains 15.2 mg tamoxifen citrate, which is equivalent to 10 mg tamoxifen. The recommended daily dose is 20-40 mg. Dosages greater than 20 mg per day should be divided into morning and evening doses. A 20 mg dose of SOLTAMOX is administered as 10mL of the oral solution. Use of SOLTAMOX in a risk reduction setting (women at high risk for cancer and women with ductal carcinoma in situ) has been shown to cause cancer of the uterus, as well as stroke and blood clots. Some of these strokes, blood clots, and uterine malignancies were fatal. The benefits of SOLTAMOX outweigh its risks in a population of women already diagnosed with breast cancer. SOLTAMOX should not be used in women who require concomitant use of coumarin-type anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting). , or in women with a history of deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen.  or pulmonary embolus. Women who are pregnant or plan to become pregnant should not take SOLTAMOX. Cataracts and resultant cataract surgery can also result more frequently as a result of using SOLTAMOX. The most frequently reported adverse reactions with SOLTAMOX were hot flashes and vaginal discharge.

About Cytogen Corporation

Founded in 1980, Cytogen Corporation of Princeton, NJ, is a biopharmaceutical company dedicated to improving the lives of patients with cancer by acquiring, developing and commercializing innovative molecules targeting the sites and stages of cancer progression. Cytogen's marketed products include QUADRAMET(R) (samarium samarium (səmâr`ēəm), metallic chemical element; symbol Sm; at. no. 62; at. wt. 150.36; m.p. 1,072°C;; b.p. 1,791°C;; sp. gr. 7.54 at 20°C;; valence +2 or +3. Samarium is a lustrous silver-white metal.  Sm-153 lexidronam injection), PROSTASCINT(R) (capromab pendetide) kit for the preparation of Indium In-111 capromab pendetide, and SOLTAMOX(TM) (tamoxifen citrate, oral solution 10mg/5mL) in the United States. Cytogen's development pipeline consists of CYT-500, a therapeutic radiolabeled antibody targeting prostate-specific membrane antigen (PSMA PSMA Public Sector Mapping Agencies (Australia)
PSMA Prostate-Specific Membrane Antigen
PSMA Power Sources Manufacturers Association
PSMA Pakistan Sugar Mills Association
PSMA Professional Services Management Association
), a protein highly expressed on the surface of prostate cancer cells and the neovasculature of solid tumors. Cytogen also has exclusive United States marketing rights to COMBIDEX(R) (ferumoxtran-10) for all applications, and the exclusive right to market and sell ferumoxytol (previously Code 7228) for oncology applications in the United States.

For more information, visit http://www.cytogen.com or call 800/833-3533 or 212/253-8881.
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Publication:Biotech Business
Date:Oct 1, 2006
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