Endocyte Inc fka ECYT

[bob smith]

- EC145 and EC20 Granted Orphan Drug Status by European Commission -

- Updated Overall Survival Data Improved Compared to Interim Analysis -

WEST LAFAYETTE, Ind., March 13, 2012 (GLOBE NEWSWIRE) -- Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced that, per discussions with EU health authorities, the Company will submit EU conditional marketing authorization applications (MAA) for EC145 and EC20 for treatment of patients with folate-receptor positive platinum resistant ovarian cancer. The therapeutic, EC145, and the diagnostic imaging agent, EC20, have also both been granted orphan drug status by the European Commission.

"After discussions with EU health authorities about Phase 3 trial plans and updated clinical data, including an updated overall survival analysis, we are pleased to move forward with these applications," said Ron Ellis, Endocyte's president and chief executive officer. "Targeting patients with a high unmet medical need is a prerequisite to pursuing this regulatory path and, by any measure, these patients fit that definition."

Endocyte plans to file two marketing authorization applications, one application for EC145 and another for EC20, in the third quarter of 2012. This will ensure that the Phase 3 PROCEED trial enrollment is well underway. Per agreement with the EU regulators, if conditional marketing authorization is granted, data from the PROCEED trial would be submitted following authorization and PROCEED would serve as the confirmatory trial to support conversion to regular marketing authorization for EC145 and EC20.

The marketing authorization applications will be supported by four clinical studies: a Phase 1 study in solid tumors, two single-agent, single-arm Phase 2 studies in ovarian cancer and non small cell lung cancer, and the PRECEDENT trial, a randomized study in platinum-resistant ovarian cancer. The results of the PRECEDENT trial demonstrated a statistically significant delay in disease progression or death in the overall population, with the largest improvement observed in the FR(++) patient population, those with all tumors positive for the folate receptor. Women with FR(++) platinum resistant ovarian cancer who received EC145-based therapy experienced a 62 percent decrease in their risk of progression [HR 0.381, p= 0.018] compared to women receiving chemotherapy alone. Median progression free survival (PFS; the time without disease progressing) in the EC145 based treatment arm was 5.5 months compared to 1.5 months of women who received chemotherapy alone. Tumor shrinkage (overall response rate) was observed in 17.3 percent of women receiving the EC145-based therapy compared to 6.7 percent in patients treated with chemotherapy alone.

In addition, Endocyte today announced updated overall survival data from the PRECEDENT trial, which show improvement compared to the results announced in December 2011. Overall survival was a secondary endpoint in the PRECEDENT trial, but it was underpowered to demonstrate a definitive result in this endpoint. In particular, the overall survival hazard ratio for the FR(++) patient group was 1.097. Adjusting for prognostic imbalances between the study arms, the adjusted hazard ratio of 0.481 reflects a 52 percent reduction in the risk of death. Overall survival statistics in the intent-to-treat population were also slightly improved compared to those announced in December and those data will be presented at an upcoming medical conference.

"Patients with platinum-resistant ovarian cancer represent a high unmet medical need, and the presence of the folate receptor is associated with more rapid disease progression and shorter life expectancy," said Ignace B. Vergote, M.D., Ph.D., from University Hospital Leuven, in Belgium. "Because EC145 targets the folate receptor, these patients also have the potential to receive the greatest improvement over standard therapy. Being able to use EC20 to select patients who will most likely respond to the treatment will benefit both patients and doctors and is an important step towards implementing personalized medicine."

About EC145

EC145 is a conjugate of the vitamin folate and a super-potent vinca alkaloid. Folate is required for cell division and rapidly dividing cancer cells often over-express folate receptors in order to capture enough folate to support cell division. By attaching a chemotherapy drug to folate through proprietary chemistry, EC145 targets cancer cells while avoiding most normal cells. This targeted approach is designed to provide treatment with super-potent drugs while lowering toxicity compared to standard chemotherapy.

About EC20

EC20 is a folate-targeted molecular 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 EC145. To date, EC20 has been administered to over 500 patients.

About Orphan Drug Designation

EMA's Orphan Medicinal Product Designation is designed to promote the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. This designation will provide ten years of marketing exclusivity if the product candidate is approved for marketing for the designated orphan indication in the European Union. It also provides special incentives for sponsors, including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development or at the time of application for marketing approval.

About Endocyte

Endocyte is a biopharmaceutical company developing targeted therapies for the treatment of cancer and inflammatory 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 enrollment of patients in clinical trials, the ability to select patients with EC20, and the acceptance of regulatory filings by regulators. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that could cause such a difference include the prolonged unavailability of Doxil, adverse regulatory developments, and the fact that clinical data from one trial may not be replicated in a subsequent trial. 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.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: Endocyte, Inc.

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CONTACT: Stephanie Ascher Stern Investor Relations, Inc. [phone] [e-mail] Martina Schwarzkopf, Ph.D. Russo Partners [phone] [e-mail] Tony Russo, Ph.D. Russo Partners [phone] [e-mail]