• 3/6/2007
  • New Rochelle, NY
  • press release
  • Genetic Engineering News (www.genengnews.com)

Cytogen Corporation today announced the launch of Caphosol Relieves Oral Mucositis, an educational support program for patients and caregivers. The announcement comes as Cytogen establishes an expanded market presence for Caphosol, an advanced electrolyte solution indicated in the U.S. as an adjunct to standard oral care in treating oral mucositis (OM) caused by radiation or high dose chemotherapy. Caphosol, a prescription medical device, is also indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause or whether the conditions are temporary or permanent.(1) Caphosol is available through U.S. wholesalers nationwide.

CARE OM

As part of its commitment to advancing the treatment and care of cancer patients, Cytogen is proud to announce the launch of CARE OM – a web-based education and support center for patients and caregivers seeking to learn more about OM and Caphosol . In addition to oral mucositis educational material and support information, visitors to CARE OM, located at http://www.caphosol.com/careom, can also download an OM brochure or request a free brochure about OM by mail.

“The CARE OM program is designed to help raise awareness of oral mucositis –one of the most common and debilitating complications of cancer treatment,” said Michael D. Becker, president and chief executive officer of Cytogen Corporation. “As we make Caphosol more widely available in the U.S., our goal is to improve the quality of cancer patients’ lives through the effective management of oral mucositis.”

Oral complications including mucositis and salivary gland dysfunction are common and often debilitating side effects of cancer therapy. Oral mucositis is estimated to affect more than 400,000 cancer patients each year.(2) Oral mucositis affects approximately 40% of cancer patients who receive chemotherapy, more than 70% of those undergoing conditioning therapy for bone marrow transplantation, and virtually all patients receiving radiation therapy for head and neck cancer.(3)

Cytogen, which acquired the exclusive North American marketing rights to Caphosol from InPharma AS (Norway, private) in October 2006, aims to enhance public awareness of OM, and increase the availability of Caphosol . “Our experience in the medical and radiation oncology markets makes Cytogen well-positioned to spread the word about oral mucositis, and to aggressively expand CAPHOSOL availability to patients who can benefit from its use,” added Mr. Becker.

“Oral mucositis is one of the most common and painful side effects we see in our cancer patients,” said Athena Papas, DMD, PhD, Tufts University School of Dental Medicine. “We need to raise awareness of oral mucositis among physicians and nurses and increase support for patients and caregivers managing oral mucositis.”

About Caphosol

Caphosol, an advanced electrolyte solution, is a U.S. patented, prescription medical device that lubricates the mucosa and helps maintain the integrity of the oral cavity through its mineralizing potential. CAPHOSOL facilitates chewing and speaking; loosens tough mucus and prevents mucous membranes from sticking together.

A prospective, double-blind, randomized trial comparing Caphosol to a placebo rinse demonstrated that Caphosol has a significant effect on amerliorating oral mucositis caused by radiation and/or chemotherapy. In patients undergoing a hematopoietic stem cell transplantation (HSCT), it was observed that the frequency, duration and severity of oral mucositis was significantly less in the Caphosol group than in the control group.(4)

A prospective, randomized, double-blind, placebo-controlled trial demonstrated Caphosol to be a significant adjunct in the management of mucositis associated with high-dose chemotherapy and radiation therapy. The trial evaluated 95 patients undergoing hematopoietic stem cell transplantation with the duration and severity of mucositis and requirements for opioid medications prospectively evaluated. Data demonstrated significant decreases in days of mucositis (3.72 vs. 7.20, P=0.001), days of pain (2.86 vs. 7.67, P=0.0001), dose of morphine (30.46 mg vs. 127.96 mg), and days of morphine (1.26 vs. 4.02, P=0.0001) for patients receiving Caphosol as compared to those administered a placebo. The lead investigator for the study was Athena Papas, DMD, PhD, Department of Oral Medicine, Tufts University School of Medicine, Boston, MA and results were published in the April 2003 issue of Bone Marrow Transplantation (Papas et al. Bone Marrow Transplant. 2003 April;31(8):705-12).

Caphosol Indications

Caphosol is indicated in the U.S. as an adjunct to standard oral care in treating oral mucositis caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain. Caphosol is also indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause or whether the conditions are temporary or permanent. Caphosol is an unclassified medical device and is marketed under a 510(k) Pre-market Notification Application.

Cytogen will also provide extensive support and service designed to help increase access to Caphosol. For support with benefit verification, prior authorization and reimbursement information, please call 1-866-359-9290 or email inquiries to [email protected].

References:
1.Meraw, Stephen J., and Charles M. Reeve. “Dental Considerations and Treatment of the Oncology Patient Receiving Radiation Therapy.” Journal of the American Dental Association 129 (1998): 201-205.
2.Rubenstein EB, Peterson DE, Schubert M, Keefe D, McGuire D, Epstein J, et al. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer 2004;100(9 Suppl):2026-46. [p. 2031, col 1,
para 5]
3.Köstler WJ, Hejna M, Wenzel C, Zielinski CC. Oral mucositis complicating chemotherapy and/or radiotherapy: options for prevention and treatment. CA Cancer J Clin 2001;51:290-315. [p. 291, col 1, para 1]
4.Sonis, Stephen T. “Oral Mucositis in Cancer Therapy.” Supportive Oncology 2 (2004): 3-8.
5.Redding, Spencer W. “Cancer Therapy-Related Oral Mucositis.” Journal of Dental Education 69 (2005): 919-929.
6.CAPHOSOL Prescribing Information.
7.Papas AS, Clark RE, Martuscelli G, O’Loughlin KT, Johansen E, Miller KB. A prospective, randomized trial for the prevention of mucositis in patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant 2003;8:705-12. [p. 709,
col 2, para 6]
8.On-line Medical Dictionary. Mucositis. Centre for Cancer Education, University of Newcastle upon Tyne. Available at: http://cancerweb.ncl.ac.uk/cgi-bin/omd?query=mucositis.