Clarient Granted Exclusive License to Commercialize Cancer Biomarker by Minerva Biotechnologies

November 30, 2009

ALISO VIEJO, Calif. and WALTHAM, Mass., Nov. 30 /PRNewswire-FirstCall/ — Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that privately held, Waltham, MA-based Minerva Biotechnologies has granted it the exclusive right to develop and commercialize a test that identifies the MUC1* protein, a biomarker researchers believe may be implicated in the spread of many cancers, including breast cancer.

“We believe MUC1* has the potential to have an impact on cancer diagnostics,” said Clarient Chief Executive Officer Ron Andrews. “It’s early in the evaluation process, but it may have significance in diagnosing, selecting therapy, and monitoring therapeutic efficacy in solid tumors. Early research has also demonstrated that MUC1* may play a role in developing resistance to cancer drugs, which means if you can block MUC1*, you may be able to overcome resistance to a drug and, once again, offer that therapy.”

Andrews said the relationship with Minerva and its biomarkers fits very well within Clarient’s business model.

“Our growth model includes collaborating with academia and innovative companies, wherein the value of new biomarkers are defined,” Andrews said. “Once validated, we can move forward with commercialization by taking the test to market via our robust national pathology distribution network. That is exactly what we are doing with the MUC1* test.”

Commenting on the license arrangement, Dr. Cynthia Bamdad, Founder and Chief Executive Officer of Minerva Biotechnologies, said, “We are very excited to have Clarient as our commercialization partner for our MUC1* diagnostic test. The MUC1 story has garnered a great deal of attention recently with Minerva’s discovery that MUC1 is in an altered form, called MUC1*, on embryonic stem cells and on cancer cells. This is the first direct evidence that cancer cells grow by hijacking a normal stem cell mechanism that usually exists in a dormant state on healthy adult cells. Minerva has compelling evidence that cancer cells that grow resistant to anti-cancer drugs do so by producing more MUC1*.”

Dr. Bamdad continued, “The November issue of the journal Breast Cancer Research and Treatment includes our article outlining how the blocking of MUC1* can reverse an acquired resistance to cancer drugs, increasing the therapeutic choices for certain solid tumors.”

Clarient estimates it would take about a year of further development to thoroughly evaluate the predictive value of measuring an amount of MUC1* in a patient’s sample. Currently, there is no MUC1*-targeting drug available, but in the long term, the test could identify patients who would benefit from a MUC1*-disabling drug. The two companies expect to collaborate on critical studies to validate the clinical utility of the marker as well as supporting papers and scientific presentations at major oncology symposia.

“We continue to make definitive progress on what biomarkers are implicated in which cancers, so we need to be proactive in evaluating new markers, such as those implicating MUC1*,” Andrews added. “We spent the first five years building a commercial channel that could deliver complex cancer testing information into every community in the US, and building out a base menu of services to support the community pathologists. Now we are leveraging our channel to strengthen our menu of proprietary tests for the key cancers we serve. If MUC1* turns out to be as valuable as some believe, especially for women who have developed a resistance to certain targeted therapies, it would be a significant product in our arsenal.”

About Clarient

Clarient combines innovative diagnostic technologies with world-class pathology expertise to assess and characterize cancer. Clarient’s mission is to become the leader in cancer diagnostics by collaborating with the healthcare community to translate cancer research and development into better patient care. Clarient’s principal customers include pathologists, oncologists, hospitals and biopharmaceutical companies. The rise of individualized medicine has created the need for a centralized resource which provides leading oncology diagnostic technologies, such as flow cytometry and molecular testing. Clarient is that resource, having created a state-of-the-art commercial cancer laboratory, which provides the most advanced oncology testing and diagnostic services available. Resulting diagnostic reports and analyses are made available to customers through Clarient’s Internet-based portal, PATHSiTE(TM). Clarient is also developing and marketing new, proprietary “companion” diagnostic markers for therapeutics in breast, prostate, lung and colon cancers, and leukemia/lymphoma. www.clarientinc.com

About Minerva

Minerva Biotechnologies uses its proprietary nanoparticle technology to develop novel therapeutic and diagnostic agents that target the MUC1* growth pathway. The Company has developed diagnostic tests that detect the tumorigenic form, MUC1*, but not the normal form, MUC1. Minerva is developing, as anti-cancer agents, monoclonal antibodies and small molecules that disable MUC1*.

Minerva has also developed novel agents that stimulate MUC1*, which enable high throughput and automated growth of pluripotent stem cells, without the need for feeder cells, their conditioned media, matrigel or other animal substances. www.MinervaBio.com

Forward Looking Statements

Certain statements herein regarding Clarient, Inc. contain forward-looking statements that involve risks and uncertainty. Future events and the Clarient’s actual results could differ materially from the results reflected in these forward-looking statements. Factors that might cause such a difference include, but are not limited to: Clarient’s ability to continue to develop and expand its diagnostic services business, Clarient’s ability to expand and maintain a successful sales and marketing organization, Clarient’s ability to maintain compliance with financial and other covenants under its credit facilities, limitations on Clarient’s ability to borrow funds under its credit facilities based on Clarient’s qualified accounts receivable and other liquidity factors, Clarient’s ability to obtain annual renewals of or replacements for its credit facilities, the effects of a going concern audit opinion on Clarient’s operations, Clarient’s ability to successfully transition its billing function in-house from a third party vendor, Clarient’s ability to remediate the material weaknesses in its internal control over financial reporting, the continuation of favorable third-party payor reimbursement for laboratory tests, Clarient’s ability to obtain additional financing on acceptable terms or at all, unanticipated expenses or liabilities or other adverse events affecting cash flow, uncertainty of success in identifying and developing new diagnostic tests or novel markers, Clarient’s ability to fund development of new diagnostic tests and novel markers and the amount of resources Clarient determines to apply to novel marker development and commercialization, failure to obtain FDA clearance or approval for particular applications, Clarient’s ability to compete with other technologies and with emerging competitors in novel cancer diagnostics and dependence on third parties for collaboration in developing new tests, and risks detailed from time to time in Clarient’s SEC reports, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. Recent experience with respect to laboratory services, revenues and results of operations may not be indicative of future results for the reasons set forth above.

Clarient does not assume any obligation to update any forward-looking statements or other information contained in this document.

Investor Contacts
For Clarient:                             For Minerva:
Matt Clawson                              Ron Axelrod
Clarient, Inc.                            Minerva Biotechnologies
(949) 474-4300                            (617) 785-9491
matt@allencaron.com                       raxelrod@minervabio.com

SOURCE Clarient, Inc.; Minerva Biotechnologies

Source: newswire

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