Complete Results of Phase 2 trial of Biomoda’s Lung Cancer Test Anticipated (NASDAQ:BMOD)

Biomoda, Inc. (NASDAQ:BMOD.OB), whose headquarter is in Albuquerque, New Mexico, is a company that discovers and develops precise, safe and cheap in-vitro tests that diagnose cancer in the early stage – the period of time when it is most possible for treatment methods to cure the cancer or to stop the cancer from getting worse. The company’s pipeline consists of a number of innovative tests – which people with modest incomes can use to diagnose life-threatening cancers. All its tests have patented under the trademark CyPath (R) – which uses the compound of porphyrins that can attach to cancerous cells and flash red light in the presence ultraviolet rays. One such test is the one the company has developed to detect lung cancer in early stage in military veterans. The company had completed the Phase 1 trial in early 2009 and had started the Phase 2 trial. The Phase 2 trial had been designed to test the safety and the effectiveness of the test. On September 14, 2009, the company announced that they are going to include “a longitudinal component” – that would provide greater insight into the safety and the effectiveness of the diagnostic test. The company was initially planning to disclose to the public the complete results of its Phase 2 trial in mid 2010. However, it had decided to present the results as early as possible so that it can start the Phase 3 trial – which will include about 3500 participants.

It was not easy for Biomoda to conduct the Phase II clinical trial alone. That’s why it formed a partnership with the New Mexico Institute of Mining and Technology (NM Tech) and the New Mexico Department of Veterans Services (NMDVS). Under the partnership agreement, all the three companies would bear responsibility for the Phase 2 trial.

The quality of the Phase 2 trial has been greatly improved by the inclusion of the longitudinal component – which will ensure that “deep-lung sputum samples” are collected from the participants of the Phase 2 trial. The samples are then tested with both “CyPath (R) assay and Pap staining” to detect cancerous cells. In addition, the participants are also scanned with computed tomography (CT).  The number of participants is also incredible – more than 500.

John J. Cousins, who is the Chief Executive Officer and also the President of Biomoda, Inc., said:

“Study participants whose initial results indicated areas of concern — the presence of nodules on the lungs or a positive read for cancer cells — have been asked to return for follow-up screening. The ability to monitor study participants over the long term will no doubt result in a better medical outcome for them as well as provide invaluable data for Biomoda as we prepare for Phase III pivotal trials and FDA approval. Staying in contact with study participants and monitoring their lung health will help us expand the utility of the CyPath(R) assay beyond early diagnosis to actually measuring the success of treatment. We will eventually be able to tell patients how effectively their therapy is targeting their cancer.”

Everything is going well for Biomoda and its in vitro test. For instance, the company has announced on January 25, 2010 that the state senator of Nebraska, Bob Krist, – together with his sponsors – is trying to get Legislative Bill 987 approved. If the legislation gets approved, it would allow a $650,000 contract between the Nebraska Department of Veterans’ Affairs and the University of Nebraska Medical Center Eppley Institute for Research in Cancer and Allied Diseases to screen about 500 military veterans in Nebraska for lung cancer – using Biomoda’s patented CyPath(R) diagnostic test.

According to John J. Cousins, this legislation is “another step towards saving lives”. He said:

“Veterans of the armed services are at least 25 percent more likely than the general population to be diagnosed with lung cancer.  Screening programs like the one proposed by this bill in Nebraska and an earlier one enacted by the New Mexico Legislature help us spotlight one of the most serious health issues facing the men and women who serve in uniform.”