|Small-cap Biomoda has pending top-line results for their Phase 2 trials|
|By Patrick Crutcher|
|Thursday, 09 September 2010 03:57|
Biomoda Inc. (OTC: BMOD.OB) has kept investors waiting for top-line results from this potentially game changing Phase 2 trial. Their Phase 1 trial results showed 100% sensitivity and specificity, which for a diagnostic test is outstanding news. Based on statements and actions from the company, the Phase 2 results must be showing great promise to those involved.
In March 2009, Biomoda received Institutional Review Board (IRB) approval for its pilot Phase II clinical study. The study is in partnership(and paid for by) with the New Mexico Department of Veterans Services and is designed to screen up to 520 high- risk New Mexican veteran participants, “20 pack-year” smokers (individuals who have smoked one pack a day for 20 years or two packs a day for 10 years) for lung cancer. The primary endpoint of the study is to discover 6 to 10 asymptomatic patients in the first cohort. The primary endpoint was met after with just over 130 patients and Biomoda has completed collecting additional positive control data for another 21 patients. On June 24th, we finally had an official announcement that Phase 2 enrollment had been completed and the data analysis had begun. Now, we must wait for the top-line results to be released.
BMOD seems pretty bullish, especially since they are already planning their Phase 3 study in order to eventually file with the FDA. Sounds like the results were good enough to put in the resources for planning the next stage. In their most recent 10-Q, they said:
“The study team is completing data analysis and preparing its report for release. Results will be published at the end of the study period after data has been analyzed. The Company anticipates results sufficient to provide the foundation for a pivotal clinical study leading to submission to the FDA for approval of the commercial sale of Biomoda’s technology.”
BMOD also has a significant leader in the lung cancer field to help validate their study. Dr. Thomas Bauer, the Principal Investigator (PI) overseeing Phase II, has agreed to continue in the same role for our Phase III trials. Dr. Bauer is widely recognized as one of the top lung cancer researchers in the field, and we are privileged to be working with him. Bauer, chief of thoracic surgery at the Helen F. Graham Cancer Center, Christiana Care Health System, and head of Christiana’s participation in the International Early Lung Cancer Action Program (I-ELCAP), is coordinating site selection for the final phase of testing on the CyPath® assay. Bauer’s work with Biomoda follows the I-ELCAP Enrollment and Screening Protocol, and all sites selected for the Phase III trials will be I-ELCAP approved. This will be essential in gaining approval of their diagnostic test abroad.
Another bullish sign is that BMOD has already made it clear about their intentions to file for their CE mark in Europe, once the results have been published and the necessary patents are in place. This is something they have reiterated time and again. The EU desperately needs better lung cancer diagnostics as: "It is estimated that there are around 243,100 lung cancer deaths each year in the European Union (around 188,000 in men and 55,000 in women). Overall, "smoking is estimated to cause over half a million deaths each year in the EU and a million in Europe." Cousins and BMOD are making the EU their priority market once Phase 2 is completed. BMOD is hoping to have a CE mark by year-end and full launch in Q1-2011. Once revenue starts to flow, BMOD can think about applying Cypath to other types of cancer, which they plan to do after the initial launch for lung cancer (See their most rcent 10-Q filing and read page 20).
We also should not discount their technology’s value in other indications. BMOD intends to create and market products to diagnose and screen for other prevalent cancers, including breast, cervical, bladder, oral and colorectal. The commercial viability of an inexpensive, highly accurate diagnostic test is a strong market driven opportunity. BMOD is aiming to keep the cost of the test under $200. Given the attractive cost/benefit profile of CyPath®, it is not unrealistic to plan it will become as accepted and prevalently used as PSA, colonoscopy, mammography and PAP tests are today.
Additionally, Lifetech Capital recently updated their coverage of BMOD on 8/18/2010 with a “Strong Speculative Buy” and target price of $1. This seems very reasonable based on strong results from their Phase 2 study and future revenue potential with the diagnostic test in the EU sometime in Q1 2011.
We are bullish on Biomoda Inc.(BMOD) going forward, based on clinical data, news, and corporate actions. We advise anyone interested in Biomoda Inc. to examine them carefully, as we will be issuing an interview with the President, CEO and Director of Biomoda, Inc., John Cousins, to our general readership later this week.