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Almac, Pfizer, PETACC 3 Launch Colorectal Cancer Gene-Expression Study

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This article has been updated from a previous version to include information about Almac Diagnostics' test pipeline and its collaboration with Almac Discovery.

STOCKHOLM, Sweden — Almac Diagnostics last week said it will take part in a study with Pfizer and the translational working group of PETACC 3 to discover molecular subtypes, biomarkers, and drug targets related to colorectal cancer.

PETACC 3 is the Pan-European Trials in Adjuvant Colon Cancer effort, an international randomized, prospective trial that aims to show that adding irinotecan to combination chemotherapy regimens increases efficacy in patients with stage II/III colon cancer. The translational working group includes researchers such as Arnaud Roth from Geneva University Hospital in Switzerland and Sabine Tejpar from University Hospital Gasthuisberg in Leuven, Belgium.

Austin Tanney, Almac Diagnostics' scientific liaison manager, said that the trio plan to use Almac's Colorectal Cancer Disease-Specific Array in a retrospective study of formalin-fixed, paraffin-embedded samples. The goal is to uncover subgroups and drug targets in colorectal cancer "that may inform therapeutic development in the future."

According to Tanney, the deal will call for Almac to receive FFPE samples from PETACC 3 for a retrospective trial, which the firm will analyze in its facilities in the UK. Almac Diagnostics maintains labs at both its headquarters in Craigavon, UK, and in Research Triangle Park, NC.

Tanney spoke with BioArray News during Select Biosciences' Advances in Microarray Technology meeting, held here last week.

Almac's Colorectal Cancer DSA — more than half of whose contents the firm claims is unique — is manufactured on the Affymetrix GeneChip platform and is currently available for research use only. However, Almac has said it has diagnostic ambitions for the chip, and has partnered with Massachusetts General Hospital and others to prepare a prognostic signature for stage II colorectal cancer for an eventual 510(k) submission to the US Food and Drug Administration.

Almac had hoped to debut the clinical version of the assay last year, but Tanney this week said that it is in the "final stages of development" (see BAN 5/29/2007).

Tanney said that the aim of the study with Pfizer and PETACC 3 is to "discover subgroups and drug targets in colorectal cancer that may inform therapeutic development in the future." Almac also said it sees the deal as a vote of confidence in its DSA platform and its biomarker–discovery chops.

"I think our ability to work with FFPE samples is a large component of the deal," Tanney said. "It's also the fact that we can offer unique information using the Colorectal DSA. It is good to be in a situation where the largest pharmaceutical companies in the world are recognizing the value of our platform and expertise."

According to Tanney, pharma companies have increasingly been looking to outsource their drug-development work. "Pharma doesn't necessarily want to make diagnostics; they want to sell drugs," Tanney said. "So we are seeing more interest in pharma companies partnering with diagnostics firms like Almac and outsourcing that kind of work."

From DSA to 510(k)

Almac also plans to use the Colorectal Cancer DSA to develop diagnostics. So far, the firm has partnered with Massachusetts General Hospital and others to prepare a prognostic signature for stage II colorectal cancer for an eventual 510(k) submission to the US Food and Drug Administration.

Almac had hoped to debut the clinical version of the assay last year, but Tanney said last week that it is in the "final stages of development" (see BAN 5/29/2007).

In a separate interview, Almac Diagnostics President Paul Harkin called the colorectal test the "most advanced" in the company's pipeline. "At this moment in time, it is going through its first validation," he told BioArray News this week. "Our intention is to commercialize that in 2010 as a microarray-based test for use with FFPE samples." According to Harkin, the firm plans to submit the test to the US Food and Drug Administration for 510(k) clearance.

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In addition to its colorectal cancer prognostic, Almac is also developing tests for stage I lung cancer, which Harkin called a "pure prognostic recurrence assay," as well as the recurrence of ductal carcinoma in situ, or early-stage breast cancer. Both tests have been in development for several years (see BAN 8/7/2007).

All of the assays being developed at Almac run on the Affymetrix GeneChip platform, and Almac signed a diagnostics agreement with Affy in 2005. Harkin said that Almac is "very happy" with the GeneChip platform, but noted that Almac is platform independent.

That independence supports Almac's aspirations to build the companion diagnostics wing of its business. Harkin said that companion diagnostics represent a "greater possibility" for the firm, and that Almac not only uses arrays but also qPCR assays in its companion tests.

Discovery and Diagnostics

Almac Diagnostics is also intensifying its collaboration with Almac Discovery, a new arm of the Almac Group that was established last year to develop approaches to treat cancer and associated conditions, with the goal of developing a biomarker or diagnostic in parallel with each potential new therapeutic (see BAN 6/17/2008).

Harkin said that Almac Diagnostics and Almac Discovery are currently focused on prostate cancer. "There is a strategic focus on that disease," said Harkin. "We are using Diagnostics' DSA technology to identify novel therapeutic targets in that disease setting, looking for targets from tumor material initially."

Almac Discovery President Stephen Barr told BioArray News this week that Discovery was "set up to focus more on R&D, adopting a higher-risk, higher-rewards strategy." According to Barr, Discovery is unlikely to take on projects like Diagnostics' collaboration with Pfizer and PETACC 3.

"We are looking at developing early-stage and late-stage projects to have a well-rounded portfolio in the company," Barr said. Within Almac, Diagnostics will be charged with validating potential targets to a certain point. Discovery will then progress to compound development as targets are identified. He added that Discovery is also working on a number of in-licensed targets from academia.