Re: is anyone thinking or expecting any movement in the sp or
posted on
Jan 05, 2016 01:00PM
Fuzzy,
As you wrote, we are still awaiting an update about the FDA. Also, the clinicaltrials.gov and EU Clinical Trials register sites haven't been updated for a while. So how many countries/study sites have been activated for BETonMACE? How is patient enrollment going? When will China start enrolling patients in their arm of the BETonMACE trial? I think these types of clarifications will better solidify confidence in the trial and may even promote further interest in the stock.
We are also awaiting updates about the new trial with RVX-208 for complement-mediated diseases. As per their latest blog, "Resverlogix is currently engaged in designing a pilot proof-of-concept trial in complement mediated diseases, with the first clinical trial in Paroxysmal Nocturnal Hemoglobinuria (PNH)."
What about the Alzheimer's trial for RVX-208 that RVX has so often said is in the planning stage? The RVX website currently states "With leading experts on the neurodegenerative clinical and scientific advisory board providing input and guidance, a Phase 2 clinical study in this therapeutic area is planned."
What about the additional kidney trials for that have been mentioned in the recent past for Resverlogix?
What about the RVX-208 follow on molecules that have been selected? What are the plans for these?
Don had also mentioned in the Fall that there would be a couple of big scientific publications in early 2016 for Resverlogix. So we may get an update on the content and timeline of these.
It's not clear if you are talking about Zenith loan or RVX loan. RVX loan isn't due until August 2017......a good 20 months from now. Zenith has only done private placements thus far, as far as I can tell, so no Zenith loan to pay back. Please correct me if I am wrong.
Regarding Zenith.....I am very hopeful that we will hear a lot about the clinical trial(see below), novel approaches for patient subset collection, more info about the Zenith Capital Corp/Zenith Epigenetics Ltd arrangement and get an updated timeline for Nasdaq IPO.
Masila posted a few days ago on the Zenith Agoracom hub that Zenith has interim financials and MD&A on SEDAR 12/24. Masila noted the following highlights:
"In April 2015 we selected a new clinical development candidate, and we have completed IND enabling studies. We filed an IND in December 2015 and plan to initiate Phase 1 clinical trials in early calendar 2016. We also continue to progress our preclinical programs, expand our medicinal chemistry operations with leading global contract research organizations, and grow our intellectual property estate.
We are advancing multiple BET inhibitor programs through discovery and early preclinical development that are differentiated from the competing 1st generation BET programs which are in Phase 1 development. These programs provide us with multiple opportunities for developing a best-in-class BET inhibitor with a potential better efficacy and safety profile:
1. Reversible Pan BET inhibitors: These 2nd generation inhibitors, compared to competing BET inhibitors, have shown better preclinical efficacy, better drug like properties, and are not encumbered by any safety issues unlike competing 1st generation BET inhibitors.
2. Covalent BET inhibitors: These inhibitors have sustained effect on cell proliferation and pharmacodynamic modulations compared to reversible inhibitors and have the potential to providing increased efficacy.
3. Bromodomain 1 (“BD1”) selective BET inhibitors: These inhibitors only bind to the BD1 domain of BET proteins and are expected to provide novel biology and the potential for a superior efficacy/safety profile.
In April 2015, we selected a new reversible Pan BET inhibitor clinical development candidate. We completed IND enabling studies and filed an IND in December 2015. In parallel, we have defined our clinical development strategy which will be focused on targeting patient subsets with high unmet need and those that are most likely to benefit from therapy. Zenith will implement a translational medicine approach to our programs as they advance to clinical development."
So yes, I think there is a good chance for some new "significant" info to be revealed in the next couple of weeks.
BearDownAZ