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Pinnacle Biologics Files for Orphan Drug Designation for PHOTOFRIN® in the Treatment of Patients with Malignant Mesothelioma.
Date:10/24/2011

BANNOCKBURN, Ill., Oct. 24, 2011 /PRNewswire/ -- Pinnacle Biologics, Inc., a privately held specialty bio-pharmaceutical company announced today that it has filed 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 file for the Orphan Drug Designation of PHOTOFRIN® and potentially for its utilization in 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 committed to support the approval and expand the use of PHOTOFRIN® into new indications such as Malignant Pleural Mesothelioma, where preliminary clinical results are very encouraging."

According to Joseph S. Friedberg, MD, Chief, Section of Thoracic Surgery - Penn Presbyterian Medical Center; Co- Director, Penn Mesothelioma and Pleural Disease Program at Penn Medicine, "In studies completed at Penn, photodynamic therapy (PDT), in conjunction with surgery, has shown some very promising results for the treatment of mesothelioma, a highly lethal cancer of the chest cavity lining.  By utilizing PDT as an intraoperative treatment, we have been able to develop a technique where we can reliably preserve the patient's lung. When compared to other treatments, this combination of lung-sparing surgery, PDT and standard chemotherapy appears to have a positive impact on both survival and quality of life. Based upon our clinical observations, characterizing the PDT effect and working on techniques to magnify it has become a major focus of our research. "

About Photodynamic therapy (PDT) and PHOTOFRIN®

Photodynamic therapy (PDT) 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 Web Site http://www.cancer.org/Cancer/MalignantMesothelioma
  2. National Center for Biotechnology Information –  PubMed Web Site http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004462
  3. National Cancer Institute – Web Site http://www.cancer.gov/cancertopics/types/esophageal

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. Joseph S. Friedberg has no financial relationship with Pinnacle Biologics Inc. 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.


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SOURCE Pinnacle Biologics, Inc.
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