|FDA Calendar Updates: Biomoda, Dynavax|
|Tuesday, 04 August 2009 15:47|
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 286 entries as of 8/4/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
On 8/4/09, Biomoda (BMOD.OB) announced that 500 New Mexico veterans have committed to participate in a state-funded program for the detection of early-stage lung cancer based on the Company's proprietary technology, which is currently in development as an inexpensive, simple, and highly accurate in-vitro test for early detection of lung cancer. The assay is based upon Biomoda's patent estate centered on molecular marker technology, originally developed at Los Alamos National Labs. Internal validation testing results have shown near 100% accuracy of the assay with no false positives or false negatives. Eventual commercial level accuracy in the 90% range is to be reasonably expected compared to PAP staining which is 64% accurate.
Biomoda submitted a Pre-IDE to the FDA who responded favorably, and the Company's Phase 2 Clinical Trial is underway as part of a larger screening program in partnership with the New Mexico Department of Veterans Services (NMDVS) and New Mexico Tech (NMT) to screen veterans for lung cancer in New Mexico. Biomoda has enrolled over 500 participants in the program and have run more than 90 through the collection procedure with results of this 300+ patient study expected in the fall of 2009 (the 10/31/09 date for this entry is only an estimate within this timeframe).
The study will be expanded to 3,500 patients thereafter as a Phase 3 Pivotal Clinical Trial, with results of the larger study expected in 2010. Biomoda and NMT are developing an automated technology to support large-population screening for cancer. Results from these studies will be sufficient to submit to FDA for final approval as a Class III PMA IVO device, which is expected to occur in 2011.
On 8/4/09, Dynavax (NASDAQ:DVAX) announced that the Company met with the FDA to discuss plans to resume development of Heplisav, which is the Company's Phase 3 investigational hepatitis B vaccine. DVAX proposed the continued clinical development of Heplisav in populations that are less responsive to current licensed hepatitis B vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and other groups such as individuals infected with HIV or diagnosed with chronic liver disease. The FDA expressed a general agreement that these populations are appropriate for further clinical development, pending the review of the study protocols and additional supportive data.
DVAX plans to submit this information to the FDA in August 2009 with a goal of having the agency remove the clinical hold in September 2009. The Company is prepared to restart clinical trials in individuals with chronic kidney disease upon removal of the clinical hold. Phase 3 data from the PHAST clinical trial demonstrate subjects over 40 years of age receiving two doses of Heplisav over one month achieved a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six months. Over 2,500 individuals have been vaccinated with Heplisav to date. Dynavax has worldwide commercial rights to Heplisav, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
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