Farmas USA

Y yo solo para un rebote y si sale mal fuera rápidamente. Por lo demás en estos momentos
seguiré el mejor consejo, esperar y ver en general.

CLSN

enrollment of the first patient in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company's DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed ovarian cancer patients who will undergo neoadjuvant chemotherapy.

The OVATION Study will seek to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. The trial is designed to enroll three to six patients per dose level and will evaluate safety and efficacy and attempt to define an optimal dose for a follow-on Phase I/II study combining GEN-1 with Avastin® and Doxil®.
http://investor.celsion.com/releaseDetail.cfm?ReleaseID=934423

GALE

collaboration with the National Cancer Institute (NCI) to initiate a new, Phase 2 clinical trial with NeuVax™ (nelipepimut-S) in patients diagnosed with Ductal Carcinoma in Situ (DCIS). The trial will be entitled, VADIS: Phase 2 trial of the Nelipepimut-S Peptide VAccine in Women with DCIS of the Breast.

The trial is expected to initiate in the fourth quarter of 2015.

NeuVax generates a significant and potent HER2 directed T-cell response, and this Phase 2 clinical trial will evaluate the CD8+ T cell response generated by NeuVax and whether this induced activation of the immune system suppresses the growth of DCIS cells

The Phase 2 clinical trial will be a single-blind, double arm, randomized, controlled trial comparing NeuVax combined with the immunoadjuvant granulocyte-macrophage colony-stimulating factor (GM-CSF) versus GM-CSF alone-

The trial will enroll a total of 48 patients randomized in a 2:1 ratio, 32 in the active arm and 16 in the control arm. After completion of local therapy to include surgery and when indicated, radiation, the treatment regimen will consist of three doses prior to, and three doses after surgery, for a total of six injections of either vaccine or control, depending on the arm in which the patients are randomized. The primary endpoint for the trial is immunological, evaluating NeuVax peptide-specific cytotoxic T lymphocyte (CTL; CD8+ T cell) response in vaccinated patients compared to patients receiving GM-CSF alone. Secondary endpoints include safety, immune response via epitope spreading, presence of DCIS at resection, and difference in HER2 expression.

ocat
presentación de ayer

http://investorstemcell.com/forum/22-twenty2/52126.htm#post314733

OCAT

Que no me das tiempooo.

Info destacable a parte de lo que he ido poniendo últimamente

So we’re designing a study which we believe will be a Pivotal Control Study for European conditional approval. We’re also gaining feedback from the FDA as we speak regarding the proposed design of the study going forward. I have to say that I have worked in a few companies now, but this is the first time that I’ve really seen a very, very high level of engagement by FDA with respect to what we are doing.

We have other photoreceptor programs in place. We just received an NIH grant for one of these. If you look at the eye as a disease site, there is a spectrum of ocular disorders we can actually attack. We have photoreceptor progenitors which are next on the list of programs for us.

We have seen this in animal models, where you can generate a photoreceptor layer where none existed before. What we’ve been able to do is restore vision in completely blind animals in the studies that we did at the University of Oxford in the UK.

I think the one disease where these photoreceptor progenitor cells could be really useful is in retinitis pigmentosa, which is an orphan disease. It affects about 95,000 to 100,000 people in this country and it’s a very, very large unmet medical need.

We’re also able to make things like retinal ganglion progenitor cells, which we use for treatment of glaucoma, and there are various other cells we’re looking at in the company.

photoreceptor progenitor work, which is coming up for publication fairly soon.

We are looking at producing anti-inflammatory cells from embryonic stem cell source, which show very, very potent autoimmune behavior, and we’re looking at an allogeneic cell therapy that could be used to induce remission in inflammatory disorders such as lupus and Crohn’s disease. We also received an NIH grant for this

SPA feedback from FDA being received on an informal basis to provide guidance for future POTENTIAL submission and studies

For Crohn’s disease, our intent now is to find a way, potentially with a partner, to get this into Phase I studies in the next 2 to 3 years.

Y la sesión de pregutnas y respuestas

Q & A - With Paul Wotton

18. Q: It’s very encouraging for me to see that you improved visual acuity in those patients with very low, very poor baseline vision. How do you review your RPE cells, more likely to restore vision or more about preserve vision.

19. A: For the benefit of those behind us, the question was will the RPE cells continue to maintain vision or will they actually improve vision when they’ve been given as an injection. What we’ve seen in the studies we’ve done is that patients who have been given a transplant actually published in the Lancet did show improvement in vision compared to baseline. What I would anticipate to the dry AMD study we’re running next, we’ll be looking at end points in that, but what we suspect to see is the control group will continue to decline with its vision. With our RPE cell transplant, if we see an increase in vision like we saw in the Lancet, that will be maintained over a 12 to 18 month period and you will see a difference growing in the two sets of patients. To date, most patients have actually seen a vision gain when they have been treated with the therapy.

20. Q: Do you have any kind of improvement beyond one year?

21. A: Yeah, we’ve actually seen patients now in the study we did in the Lancet at least, those patients have been followed up for more than two years now and the vision gains have been maintained over a two-year period. The patients who didn’t receive the cell therapy have seen no vision improvement at all over an extended period of time, and these were patients that were chosen who had very, very poor vision indeed, because the FDA wanted us to make sure, it was a safety study so patients were being injected who had very, very poor vision just out of an abundance of precaution, but to be able to improve eyesight in those patients was quite significant.

22. Q: Can you just go over your capital structure?

23. A: So we have about 43 million shares outstanding right now and there are 2.75 million warrants that we’ve done as a result of the last round. There’s no preferred stock. We just added a debt finance of $10 million dollars. It’s a straight debt transaction, competitive.

24. Q: For the SMD indication, which is most likely the first indication for potentially go to market, right? Do you plan to market on your own?

25. A: In actual fact that’s a good question because in the case of Stargardt’s disorder, which is an orphan indication, we believe that the clinical trial sites we are firing up to do that study here, which will be about a half dozen in the US, in the case of an orphan population means that you could probably treat every patient in the country at a handful of sites, so our intent, when we commercialize the Stargardt’s program, is to work with what we call these Centers of Excellence where you can actually have a very direct interaction with the physician and the patient in the case of Stargardt’s. Commercializing that won’t require much infrastructure. In the case of dry AMD, which is a much larger market, the intent here is to get to market with the orphan indication first, get the technology approved by the agency, and then come in with a dry AMD indication later on, and because that would be a larger market, we will need to expand the commercialization resources and right now I would suspect that would involve a partner.

26. Q: The question is are we looking for improvement in vision or reduction in decline for SMD.

27. A: So we have actually seen, as I mentioned earlier, we actually saw an improvement in vision in both Stargardt disorder and in AMD, and we probably see both actually. I think our goal is to improve vision. What we’ve seen typically is 3 lines on an eye chart with improvement, but if you speak to a lot of ophthalmologists, they will tell you if you could just stop the disease in his tracks, most patients would be happy with that, but I think what we’re going to have is a value proposition if you will to the patient where they should be seeing an improvement in their vision, and then what you won’t get is the continued decline, so we’ll actually see some of that in the next study that is being read out in the second quarter next year.

28. Q: Unintelligible.

29. A: It depends on the patient that you’re looking at, because they go through all kinds of ___, where they have very rapid decline , so what we’re trying to do right now, probably be after this next round of studies, is selecting patients where you can optimize the effect of

Un deseo ... necesitamos un respiro ... uno que nos lleve a 350 ... demasiado pedir??? 

IBB

 

Te acompaño en ese respiro, aunque sea un poquito menos.

NVAX

Casi 1'5 millones de cromos ya. Agarremonos a donde podamos...

Ánimo