PHASE 2 = SAFE; now let's find out how well it works.
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases 0, 1, 2, and 3, it will usually be approved by the national regulatory authority for use in the general population.
Phase 0: Pharmacodynamics and Pharmacokinetics
Phase 1: Screening for safety
Phase 2: Establishing the efficacy of the drug, usually against a placebo
Phase 3: Final confirmation of safety and efficacy
Phase 4: Sentry studies during sales
This study, with NCI, would seem to end all arguments about the safety of Imetelstat, including liver effects.
This molecular biology and phase II trial studies how well imetelstat sodium works in treating younger patients with recurrent or refractory brain tumors. Imetelstat sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Recurrent Childhood Anaplastic Astrocytoma
Recurrent Childhood Anaplastic Ependymoma
Recurrent Childhood Diffuse Astrocytoma
Recurrent Childhood Ependymoma
Recurrent Childhood Giant Cell Glioblastoma
Recurrent Childhood Glioblastoma
Recurrent Childhood Gliosarcoma
Recurrent Childhood Oligodendroglioma
Recurrent Childhood Brain Stem Glioma
Drug: imetelstat sodium
Other: laboratory biomarker analysis
Other: pharmacological study
I do not know the details, but from what I read an Amgen drug and Imetelstat (from Geron) were combined in several tests on various types of cancer cells. The combinations were significantly more effective than either drug alone.
Please correct or enlighten me. This would suggest to me that Amgen was aware of these tests, and has an interest in Imetelstat. Amgen definitely has very deep pockets.
I don't think that the hold matters anymore. Scarlett, IMO, is looking for a strong deep-pocketed partner (or a merger). All of the data, trials and relations with the FDA are being handled by Tefferi, with combination authority at Mayo & Geron. I am only looking at ASH & Mayo for medical information. Amgen's use of Imetelstat is very interesting.
ASH will resolve all issues.
Imetelstat is strong, but Geron markets are completely controlled. We still have no idea who is controlling them, and how they do it. They are making money. ASH is our major hope, with positive medical information, that cannot be ignored.
The publicity from ASH, no negative news about Imetelstat, and Mayo Clinic's successes will drive the PPS much higher. Geron will not try to go it alone. I don't know if they will choose a partner or a merger, but Imetelstat has no opposition in science and medicine that I can find. Market factors are still with us, but ASH will take care of them. This drug is too good. Amgen's work with combinations is amazing.
ASH will determine the future of Imetelstat and Geron. Either Imetelstat is a great drug (with future potential), or we have been misled. There is no way to hide the truth after the ASH presentations. I have not seen any negative papers to date (anywhere), so I am hoping for the best.
The word is finally getting around to investors, that wish for Imetelstat's successes in MF and other cancer applications, and see these positive catalysts all coming to fruition in the near future.
The remaining FDA hold is coming off soon, since the Mayo hold has been removed indicating no significant liver problems. The hold on Geron will be gone before ASH, since it serves no useful purpose. It could be removed as early as next week. There is not evidence of any liver problems that can be related to Imetelstat, or any of the MF trials at Mayo Clinic. Apparently the remaining hold is of little consequence, with the new Mayo-Geron coordinating trials.
Mainecoastlover1 & Joseph Goebbles both think the same way about "The Big Lie".** Repeat it often enough and some very naïve people will believe it.**. I find your whole attitude, your mental condition, and the state of your colon rude and offensive. You can disagree, but you can be far less disagreeable, without using offensive language.
Positive Catalysts (from the Seeking Alpha article posted on 9/2/14)
There are a number of potential positive catalysts that may occur at any time during the next six months, and sitting on the sidelines risks missing these events.
1.Transfer of IND could be complete before Sept 30
2.GERN could apply for Phase II through new IND in Oct
3.FDA could grant partial or full release anytime
4.MDS RARS publication or presentation could occur anytime
5.ASH abstracts are released early Nov
6.ASH presentation in early Dec
7.Possible partnerships announced
8.Other papers on Imetelstat expected at ASH
What makes you so negative? Mayo Clinic has done good work with Imetelstat. You keep saying they do not own it, so their good work does not count. That is totally illogical. ASH will update all the clinical trials (CR, PR, CI, etc.) and put everything into perspective. Your "conjectures" discount all the positive science and medicine that is in the public domain, and that makes no sense at all.
From blackmarango----"lws: you, of all people, should KNOW that IMET is NOT too dangerous to use. If you're dying of MF in a few months, what's the problem with liver damage years down the road???"
Of course, I agree with you. There are no indications, that I am aware of, "that IMET is too dangerous to use". The FDA hold has been discussed ad nauseam. There is no justification for it now (if there ever was), so I suspect it will soon disappear. Don't ask me to define "soon".
ASH has to resolve the remaining issues concerning Imetelstat. Either it is effective and safe, or is too dangerous to use. Geron, as an organization, is too confusing to even think about very much, but the PPS is the "investors-only-game". The medicine, and its future are in the hands of Mayo Clinic, in which I have full trust and confidence. Imetelstat will succeed, but Geron's future is "very-foggy". This is a "miracle-drug" owned by a questionable company. That condition has too change, as Dr. T coordinates both Mayo and Geron trials.
Unless Mayo Clinic is a hoax, Dr. Tefferi is a comedian, and Imetelstat's published successes are frauds, Imetelstat is the real-deal. The PPS of Geron, or its new owner, will benefit, with ASH being a very important milestone. This would type of fraud would have to be a conspiracy at the highest level, so, IMO, it is very unlikely.
"Tantamount to a Cure" means "Equivalent to a Cure". What could be clearer. Mayo is telling us to look at Imetelstat for all of its good properties now (plus potential), as they are as the #1 medical organization in the USA (to be believed and trusted). Imetelstat is a medicine that will be used for MF by Mayo, and in other telomere applications (consider Amgen). There should be a biding war going on, and perhaps Scarlett is conducting one that is not visible to mere mortals (that is the question).
If Imetestat is as good as Mayo says it is, there should be a biding-war going on now. These companies (Amgen, Gilead, Celgene) know about Imetelstat (especially Amgen, that has combined it successfully with its own drug). ASH will reveal all about Imetelstat, and Geron may be absorbed by another by then. Nobody believes that the "Liver-Hold" is a medical-scientific set-back for Mayo Clinic and Imetelstat. Geron is in a great position to negotiate for access to its "miracle drug", which it owns, with Dr. T coordinating all trials. Nothing is guaranteed, but Imetelstat looks like a winner, probably with a new partner or owner in the wings.
There are only three possibilities, using ASH as a time certain.
The Geron hold will be lifted:
1. Before ASH (BA)
2. After ASH (AA)
3. Never at All (NA)
The train has left the station, so all we can do is wait for it to arrive. ASH should answer most, if not all, questions about Imetelstat's future. I think (BA), but many believe otherwise. I am very encouraged by the recent Mayo brochure, that featured Imetelstat.