The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.
On 10/29/09, MannKind (NASDAQ: MNKD) announced that results of two Phase 1 studies demonstrate that the novel, investigational cancer vaccines MKC1106-MT and MKC1106-PP are well-tolerated and show encouraging immune response rates and objective tumor response in advanced melanoma, prostate cancer and other solid malignancies, setting the stage for Phase 2 studies.
MKC1106-MT is an active cancer immunotherapy product candidate consisting of three components, a DNA plasmid and two synthetic peptides, each of which is administered separately by the unique route of intranodal injection and together are designed to target two tumor-specific antigens that are commonly expressed by melanoma tumor cells. Findings reveal an immune response rate of greater than 40% and preliminary evidence of clinical benefit. MKC1106-PP is a similar agent that is designed to target two specific tumor antigens commonly expressed by various solid tumor cells. An immune response rate of 60% was observed and seven patients of 26 that were treated achieved clinical responses defined as partial response ((RECIST)), change in PSA doubling time or stable disease for at least six months.
On 10/29/09, RMTI announced the completion of its Phase 2b study for its dialysate iron replacement therapy, SFP (Soluble Ferric Pyrophosphate and expects to report un-blinded data from the study during 1Q10. The Phase 2b trial is a six-month, dose-ranging study in about 130 hemodialysis patients to determine the safety parameters and optimal SFP concentration to maintain normal levels of iron and hemoglobin. Earlier this week, RMTI launched a new website / logo and dropped ‘Technologies’ from its corporate name. In addition, a new section was added to the website for Bio-Pharma Development and includes additional SFP line extensions in development such as an oral prescription iron replacement therapy and other nutritional / vitamin supplements.
On 10/29/09, EXACT Sciences (NASDAQ: EXAS) made a SEC 8-K filing, stating the following, “Media reports have circulated that Kevin T. Conroy, President and CEO of Exact Sciences Corporation, is considering running for Governor of Wisconsin in 2010. Mr. Conroy is actively considering such a run. Mr. Conroy intends to remain as CEO unless or until he is elected and takes office.”
I view the announcement as a positive development since it will generate additional PR and buzz for EXAS, Mr. Conroy would only depart if elected governor, and a solid leadership team / strategy is already in place. In addition, more details are likely on the timeline for development of the Company’s stool DNA based colorectal cancer screening test kit at the upcoming 3-November conference call. Finally, it is unlikely that Mr. Conroy would consider running for governor unless he was confident on the prospects for EXAS given the relocation to Wisconsin for the Company.
During 2Q09, EXAS completed its relocation to Madison, WI, which followed a management overhaul in March that brought a new leadership team from Third Wave Technologies, including Mr. Conroy and CFO Maneesh Arora. In early August, EXAS announced the appointment of Graham P. Lidgard, Ph.D., as Chief Scientific Officer (CSO), who has over three decades of clinical / molecular diagnostics experience and a successful track record of preparing and obtaining FDA marketing clearance for 510(k) and PMA submissions that includes leading the R&D organization at Gen-Probe (NASDAQ: GPRO). Other key collaborations include the Mayo Clinic (Dr. David Ahlquist), Johns Hopkins (Dr. Bert Vogelstein), Genzyme (NASDAQ: GENZ), Case Western Reserve (Dr. Sandy Markowitz).
Disclosure: Long EXAS, RMTI