Data Published Identify the Folate Receptor as a Potential Biomarker for Targeted Therapies in a Majority of Lung Cancers

- Results Show 72 Percent of Adenocarcinomas and 51 Percent of Squamous Cell Carcinoma of the Lung Express Folate Receptor -

- Data Published in Archives of Pathology & Laboratory Medicine -

WEST LAFAYETTE, Ind., Oct. 12, 2012 (GLOBE NEWSWIRE) -- Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy in cancer and other serious diseases, today announced the publication of data showing that 72 percent of adenocarcinomas and 51 percent of squamous cell carcinomas of the lung were positive for the folate receptor (FR). Currently validated targeted therapies are effective in only a small minority of lung cancers so the FR may be an important molecular target for future lung cancer therapies. The data are published online in the journal Archives of Pathology & Laboratory Medicine.

"Lung cancer remains the number one cause of cancer death in the world, however only a limited percentage of lung cancers are candidates for targeted therapies based on EGFR mutation and ALK fusion genes, demonstrating the need for new targeted therapeutics," said Philip Low, Ph.D., chief scientific officer of Endocyte and co-author of the publication. "The high level of FR expression in lung cancer suggests that a large percentage of lung cancer patients might benefit from a FR-targeted therapy. Our use of the companion diagnostic imaging agent, etarfolatide, may allow us to select patients based on the expression of the FR immediately prior to therapy."

In the study, high-density tissue microarrays were immunostained for the FR and the immunopositivity was scored. The tissue microarrays constructed from archival formalin-fixed, paraffin-embedded resection specimens from 117 patients with primary adenocarcinomas and 71 patients with squamous cell carcinomas of the lung, either stage I or stage II.

"Our etarfolatide companion diagnostic imaging research has also demonstrated that the FR is commonly present in adenocarcinomas, approximately 80 percent of patients have tested positive for the FR," said Binh Nguyen M.D., Ph.D., vice president of clinical affairs at Endocyte. "What is particularly exciting about this new research is the presence of the FR in squamous cell carcinomas where there is an even greater need for effective folate-targeted therapies."

Endocyte has a pipeline of folate-targeted small molecule drug conjugates in various stages of clinical and preclinical development for the treatment of FR positive cancers and inflammatory diseases.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths in the industrialized world. More than 200,000 new cases of lung cancer are diagnosed each year in the United States, and more than 160,000 deaths occur annually from the disease, according to the American Cancer Society. The disease is frequently not diagnosed until it has already developed to advanced stages, resulting in a five-year survival rate of approximately 15 percent. Approximately 85 percent of patients diagnosed with lung cancer are identified with non-small cell lung cancer, and of these patients 40 to 50 percent have adenocarcinomas and 30 to 35 percent have squamous cell carcinoma.

About Etarfolatide (EC20)

Etarfolatide is a folate-targeted companion diagnostic imaging agent that is being developed as a non-invasive method to identify tumors that over-express folate receptors. These tumors are the molecular target of Endocyte's folate-targeted therapeutic compounds such as vintafolide. Folic acid is used with etarfolatide for the enhancement of image quality. To date, etarfolatide and folic acid have been administered to over 590 patients.

About Endocyte

Endocyte is a biopharmaceutical company developing targeted therapies for the treatment of cancer and other serious diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging diagnostics for personalized targeted therapies. The company's SMDCs actively target receptors that are over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly active drugs at greater doses, delivered more frequently and over longer periods of time than would be possible with the untargeted drug alone. The companion imaging diagnostics are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment.

Forward Looking Statements

Certain of the statements in this press release are forward looking, such as those, among others, relating to the potential effectiveness of folate-targeted therapies and the ability to determine the FR expression status of patients. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the company's periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Stephanie Ascher Stern Investor Relations, Inc. (212) 362-1200 Martina Schwarzkopf, Ph.D. Russo Partners (212) 845-4292 Tony Russo, Ph.D. Russo Partners (212) 845-4251 tony.russo@russopartnersllc.comSource:Endocyte, Inc.