Treatment of Patients With Malignant Mesothelioma Utilizing Photodynamic Therapy With Pinnacle Biologics' Compound PHOTOFRIN® - Obtains FDA Orphan Drug Designation

BANNOCKBURN, Ill., Dec. 14, 2011 /PRNewswire/ -- Pinnacle Biologics, Inc., a privately held specialty bio-pharmaceutical company announced today that it has obtained approval for an Orphan Drug Designation (ODD) for their product PHOTOFRIN® (porfimer sodium) as adjuvant therapy to surgery in the treatment of malignant pleural mesothelioma.

Malignant pleural mesothelioma is a form of cancer affecting the lining of the lungs. It is a rare, highly aggressive and devastating cancer with a poor prognosis. The incidence of malignant pleural mesothelioma has been linked to previous asbestos exposure and has grown from almost zero to approximately 3,000 new cases each year in the United States.(1)

"We are pleased to have obtained from the FDA the Orphan Drug Designation for PHOTOFRIN® for treatment in malignant mesothelioma," said Guillermo Herrera, Executive Chairman of Pinnacle Biologics. "Presently, the treatments for mesothelioma are palliative at best, and the outcome in patients with malignant pleural mesothelioma is very poor.  Pinnacle is evaluating current clinical data so as to formulate a plan to bring this important treatment option to patients with malignant pleural mesothelioma in the near future."

According to Patrick Ross, M.D., Ph.D., Professor Clinical Thoracic Surgery, "I am pleased with the FDA decision granting PHOTOFRIN® orphan drug designation for mesothelioma. Photodynamic Therapy (PDT) with PHOTOFRIN® has shown tremendous value as a treatment modality in several forms of cancer providing doctors and health care providers with innovative options to treat unmet medical needs such as mesothelioma and other indications presently under investigation." 

About Photodynamic therapy (PDT) and PHOTOFRIN®

Photodynamic therapy with PHOTOFRIN® is a two-stage process requiring administration of both drug and light. The first stage of PDT is the intravenous injection of PHOTOFRIN®. Illumination with non-burning laser light 40–50 hours following injection with PHOTOFRIN® constitutes the second stage of therapy. When injected, PHOTOFRIN® is attracted to and linger in certain tissues, especially cancer cells, and tumor destruction is by biochemical reactions, not by heat.  Tumor selectivity occurs through a combination of preferential retention of PHOTOFRIN® by the tumor and selective delivery of light to the tumor site.

A novel therapeutic technique, PHOTOFRIN® is FDA approved for the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. The product is available in the USA, several major European countries, Japan, several Latin American and Southeast Asian markets. Additional approved indications for PHOTOFRIN® include high-grade dysplasia (HGD) in Barrett's esophagus (BE) in North America and papillary bladder cancer in Canada and Argentina.

For additional information about PHOTOFRIN®, please see full prescribing information available at www.photofrin.com.

About Non-Small Cell Lung Cancer(2)

Lung cancer is the leading cause of cancer death in men and women. There are more than 200,000 patients with lung cancer each year. NSCLC is the most common type of lung cancer. It usually grows and spreads more slowly than small cell lung cancer.

There are several types of NSCLC including adenocarcinoma and squamous cell carcinoma. All can be treated with PDT at any stage.

About Esophageal Cancer(3)

Esophageal cancer (EC) forms in tissues lining the esophagus (the muscular tube through which food passes from the mouth to the stomach). There are two types of EC: squamous cell carcinoma and adenocarcinoma. Both types of cancer can be treated with PDT.

It is difficult to determine specific causes of EC. People with certain risk factors, however, are more likely to develop esophageal cancer. These risk factors include male gender, age 65 or older, smoking and heavy alcohol consumption. In 2010, there were approximately 16,600 new cases of EC and 14,500 deaths in the United States.

References:

1.     American Cancer Society - Malignant Mesothelioma – cancer.org
2.     National Center for Biotechnology Information –  PubMed
3.     National Cancer Institute – cancer.gov

About Pinnacle Biologics, Inc.

Pinnacle Biologics specializes in revitalizing healthcare therapies to fulfill their true potential and to maximize favorable patient outcomes. This is accomplished through licensing and acquisition of specialty pharmaceuticals and medical devices. Our innovative approach to opportunity analysis, business development, lifecycle management, regulatory expertise and distribution leverage takes each product to its highest degree of potential and maximum patient benefit.

This press release was funded by Pinnacle Biologics, Inc.  Dr. Patrick Ross has a consultant contract with Pinnacle Biologics as a Scientific Advisor. This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Pinnacle intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21W of the Private Securities Litigation Reform Act of 1995.

CONTACT:
Guillermo Herrera
Executive Chairman
Pinnacle Biologics, Inc.
2801 Lakeside Dr - Suite 209
Bannockburn, IL 60015
P: 1.847.283.7690
F: 1.847.283.7695

www.pinnaclebiologics.com
www.photofrin.com

PHOTOFRIN® is a trademark of Pinnacle Biologics Inc.

SOURCE Pinnacle Biologics, Inc.