One response from the cc that relates to other indications is below. It seems BCRX can let others do the initial exploring and if it is evident that other diseases benefit then BCRX has multitude of backup solutions to explore (by themselves or in partnerships). Maybe we're at the early stages of another HCV explosion.
Bill Sheridan: ...So all of that being said, I think your other question was around other indications. I think I would reiterate two things. One is, right now the clinical program is focused on HAE and it’s focused, focused, focused.
However, we’re not ostriches with our head in the sand, and once we have these tools that could be used in laboratory research to probe other diseases that might have significant contributions from the contact activation system and kallikrein and bradykinin pathway that would be very good tools to use to interrogate those diseases. So we’ll have those tools.
Kiwi, I didn't sense they backed off the once-a-day mantra, they mentioned it multiple times. The BofA question lead them to this answer that does bring the twice a day solution but I don't see concern with that one way or another.
"Tazeen Ahmad - Bank of America
Hi, good morning. Thanks for taking my questions. Just follow-up on 7353. You said a few times already on the call that your goal is to be a one pill per day, I’m just wondering is after you get to the end of this study, if for whatever reason it looks like 7353 might work better, let’s say as BID, would that be a non-starter for you to move forward with this molecule?
Jon Stonehouse - CEO
No. Because it’s an improvement over oral-stat. Right, so if it’s got the efficacy that we’re expecting which would be the mimic to normal phenotype and wipe out attacks, I think twice a day would be fine.
Our goal and the way we chose 7353 and the way we chose the backups was for one pill once a day, but if we ended up with twice a day, I think that's still a highly attractive drug."
Time for more (much more) patience I think.
I can't help but believe that the current trial for the first 2nd generation HAE molecule isn't living up to expectations.
1. they fiddled with the trial design and pushed the results date back
2. they introduced 2 more 2nd generation molecules (two years behind 7353)
3. [the most telling of all] they have stopped referring to the 7353 molecule as "1 pill per day wipe out attacks," but now instead claim that as a target of the "2nd generation HAE program" which includes 3 molecules, 2 of which are years behind.
I was thinking that this was finally our year, but alas. Obviously there is still Rapivab stockpiling and news on 4430 to come, but the home-run that was due out any week now, has definitely been taken off the table for this quarter, and probably for the year too. Sigh...
KalVista snags $33M from big-name VCs to speed plasma kallikrein inhibitors into clinic
...Like KalVista, Dyax is looking at disorders related to plasma kallikrein and is active in the treatment of HAE.
KalVista is well behind Dyax--which has already won approval for Kalbitor--but is hoping its oral formulation will give it an edge in HAE. The oral HAE treatment is one part of the preclinical pipeline KalVista is working to move toward the clinic. An oral therapy for DME is also in early-stage research. Collectively, the oral assets and more advanced, intravitreally delivered DME drug KVD001 represent a broad bet on the role of the enzyme plasma kallikrein in a clutch of diseases.
The enzyme system is known to play a role in HAE and may be involved with DME, inflammatory bowel disease, rheumatoid arthritis, microvascular complications of diabetes and other disorders, a breadth that means sizable markets could open up to KalVista and its competitors. Whether this happens will depend in part on the strength of the underlying scientific idea, which is based upon a belief that unusual activity of kallikrein--which normally triggers a cascade response at the sites of vascular injuries--is involved with the development of disorders.
... Existing investors Novo A/S and SV Life Sciences are financing the push with RA Capital Management, Longwood Fund and Venrock. RA Capital led the round, bagging itself a seat on the board and a stake in a second company involved with kallikreins, a subgroup of serine proteases.
my 2 cents- old yeller isn't going to raise rates in sept. (even if she does, it's already priced in.) there's a currency war that's been going on for a long time, and the ROW can't handle US raising rates…all the equities are at support/resistance levels, so i'm looking for a relief bounce…
"The Department of Health and Human Services’ annual Agency Financial Report provides fiscal and high-level performance results that enable the President, Congress, and American people to assess our accomplishments for each fiscal year (October 1 through September 30)"
They unloaded a potential $145,000,000 contract on Pfenex Aug. 17th.
In a deal potentially worth up to $143.5 million, the Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) said it would partner with Pfenex to develop Px563L, a mutant recombinant protective antigen anthrax vaccine.
...Pfenex hopes to achieve a procurement contract and to help the government achieve the goal of stockpiling 75 million active doses.
SNS, 4430 contracts....spend some 2015 money Robin.