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PROCEEDing With Endocyte

PROCEEDing With Endocyte
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3/26/2012 3:38 AM ET

Shares of Endocyte Inc. (ECYT: Quote) have gained more than 50 percent in value in less than two weeks as the company gets ready to restart a phase III ovarian cancer trial. The trial, dubbed PROCEED, was halted last year due to shortage of a comparator drug used in the study.

For readers who are new to Endocyte, here's a brief overview of its pipeline and the upcoming events to watch out for...

Endocyte uses its proprietary technology to create novel small molecule drug conjugates or SMDCs, and companion imaging diagnostics - the combination of which is designed to personalize the treatment of cancer and other serious diseases.

The company's lead product candidate is EC145, for the potential treatment of folate receptor-expressing cancers like ovarian and lung cancers. EC145 is a combination of folate (vitamin B9) and a type of anti-cancer drug known as a "vinca", and is designed to target tumors while avoiding healthy cells. This targeted approach aims to provide treatment with super-potent drugs while lowering toxicity compared to standard chemotherapy.

EC20 is the proprietary companion imaging diagnostic for EC145 - i.e. before being administered the therapeutic, EC145, the patients will have a nuclear medicine scan using the investigational imaging agent called EC20.

The most advanced clinical trial of Endocyte - PROCEED, will compare EC145 in combination with Doxil versus Doxil alone in patients with platinum-resistant ovarian cancer. Johnson & Johnson's Doxil is an approved standard therapy for the treatment of women with platinum-resistant ovarian cancer.

The PROCEED trial was initiated in May 2011 but enrollment was stopped later in the year due to global shortages of Doxil caused by temporary closing of Ben Venue Laboratories' manufacturing facility in Bedford, Ohio as product safety could not be guaranteed.

In a phase II trial, dubbed PRECEDENT, which studied the same drug combination as in the PROCEED trial, Endocyte's EC145 demonstrated 85 percent (2.3 month) improvement in median progression-free survival for treatment of platinum resistant ovarian cancer. The progression-free survival with standard therapy is approximately three months.

Earlier this month, the FDA approved Endocyte's request to import Doxil from Europe for its phase III PROCEED ovarian cancer trial. The company is all set to renew enrollment in the PROCEED trial in early second quarter of 2012. Approximately 640 women are expected to participate in the study.

Ovarian cancer is the ninth most common cancer among women, excluding non-melanoma skin cancers, according to the American Cancer Society. It is estimated that in 2012, about 22,280 women will be diagnosed with ovarian cancer and about 15,500 women will die from this disease.

The company plans to submit conditional marketing authorization applications for EC145 and EC20 in the European Union for treatment of patients with folate-receptor positive platinum resistant ovarian cancer in the third quarter of 2012. The therapeutic, EC145, and the diagnostic imaging agent, EC20, have both been granted orphan drug status by the European Commission.

Yet another indication for which EC145 is being studied is lung cancer, and the company is expected to enroll the first patient in phase 2b/3 non-small cell lung cancer trial in early second quarter of this year.

Other clinical drug candidates of Endocyte are - EC0489 under phase I study in refractory or metastatic cancer; EC0225 under a phase I study in solid tumors, which has completed enrollment; EC17, which has completed a phase I study in renal cell carcinoma patients. A phase II study of EC17 in renal cell carcinoma patients was started in 2007. But the study has been terminated.

Endocyte also has 4 drugs and an imaging agent under preclinical development.

A quick look at the company's balance sheet...

Since inception in December 1995, Endocyte has incurred losses every year, and has not generated any revenue from product sales to date.

In 2011, the company incurred an annual net loss of $40.53 million compared to a net loss of $20.09 million in 2010. However, on a per share basis, the net loss in 2011 narrowed to $1.40 from $21.77 in 2010 due to an increase in the number of outstanding shares as a result of the conversion of preferred stock and the completion of the public offerings in 2011. The company ended 2011 with $128.1 million in cash.

Endocyte went public in February 2011, offering its shares at $6.00 each. Over the past one year, the stock has hit a low of $3.02 and a high of $14.80. ECYT lost 1.11% on Friday to close the day's trading at $5.33.

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by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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