With the Harley crowd starting to age out of those type of bikes why not pick up a low mileage used one for half the price and put what you save into ONCS. If it works out the extra profit could buy you a condo in Baja.
"A possible correlation between complete response and spliceosome mutations suggests a broader therapeutic application for the drug."
Coming from Dr Tefferi who is known for his expertise in this field I take that as a very interesting comment.
We have one credible poster on this board (irishtrader52) mentioning each dosing costs $50,000, which if correct means a full years treatment at that pricing would be about a million dollars! I really hope scaling up production of Imetelstat will drastically reduce the cost, since insurance will resist paying that much, or more if a substantial profit added to it.
Better yet an oral version that does not need IV infusions, however at best that is down the road quite a while.
I'm wondering if this news concerning Jakafi could have contributed to todays price action. Geron was poised to take Jakafi's market but may have to share it going forward.
With Jakafi offering improved survival it becomes more than just a symptom (spleen size reduction) reducer.
"Meanwhile, Novartis also reported improved overall survival in patients with myelofibrosis treated with Jakavi in four long-term phase 3 studies. Jakavi (known as Jakafi in the U.S.) was approved in the U.S. and Europe for myelofibrosis in 2011 and 2012, respectively. The two phase 3 studies found that Jakavi reduced the risk of death and maintained spleen reductions for three years, and a separate study showed that it could increase the probability of 10-year survival by more than 50% when compared to conventional therapies."
You make a good point. I felt the company was pretty clear that we would see more data before year end and these would be obvious best places to do it.
What I find interesting is this appears to be the first clinical trial with Imetelstat that has had any positive results in solid tumors. Eventually we need to know the degree and duration of the partial responses. Dosing has been the limiting factor in the Imetelstat trials so I'm hoping the company is working hard on figuring out some work arounds to raise it.
A Phase I Trial of Imetelstat in Children with Refractory or Recurrent Solid Tumors: A Children's Oncology Group Phase I Consortium Study (ADVL1112)
Authors' Affiliations: 1Texas Children's Cancer Center and Department of Pediatrics; 2Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, Texas; 3Division of Oncology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; 4Children's Oncology Group, Arcadia; 5Geron Corporation, Menlo Park, California; 6Department of Oncology, Mayo Clinic, Rochester; and 7Department of Pediatrics, Hematology-Oncology, University of Minnesota, Minneapolis, Minnesota
Patrick A. Thompson, Texas Children's Cancer Center, 6621 Fannin Street, Suite 1510, Houston, TX 77030. Phone: 832-824-4029; Fax: 832-825-1503; E-mail: email@example.com
Purpose: Imetelstat is a covalently-lipidated 13-mer thiophosphoramidate oligonucleotide that acts as a potent specific inhibitor of telomerase. It binds with high affinity to the template region of the RNA component of human telomerase (hTERC) and is a competitive inhibitor of telomerase enzymatic activity. The purpose of this study was to determine the recommended phase II dose of imetelstat in children with recurrent or refractory solid tumors.
Experimental Design: Imetelstat was administered intravenously more than two hours on days 1 and 8, every 21 days. Dose levels of 225, 285, and 360 mg/m2 were evaluated, using the rolling-six design. Imetelstat pharmacokinetic and correlative biology studies were also performed during the first cycle.
Results: Twenty subjects were enrolled (median age, 14 years; range, 3–21). Seventeen were evaluable for toxicity. The most common toxicities were neutropenia, thrombocytopenia, and lymphopenia, with dose-limiting myelosuppression in 2 of 6 patients at 360 mg/m2. Pharmacokinetics is dose dependent with a lower clearance at the highest dose level. Telomerase inhibition was observed in peripheral blood mononuclear cells at 285 and 360 mg/m2. Two confirmed partial responses, osteosarcoma (n = 1) and Ewing sarcoma (n = 1), were observed.
Conclusions: The recommended phase II dose of imetelstat given on days 1 and 8 of a 21-day cycle is 285 mg/m2. Clin Cancer Res; 19(23); 6578–84. ©2013 AACR.
Received May 8, 2013.
Revision received September 10, 2013.
Accepted September 11, 2013.
©2013 American Association for Cancer Research.
No actual number but implied in the small amounts needed for trials expensive. A benefit of shutting down the Lung and Breast trials is they probably had plenty on hand for those trials that could now be shifted at no additional cost to the Myelofibrosis trial. I'll assume beneit of larger scale production would be lowered price.
I had an exchange a while back with Sergei Gryaznov, the chemist who created the lipidated version of GRN163. There had been mention of acid stability of the compound and I asked him about the possibility of making an oral version of it. Obvious huge advantage if possible. He indicated a small pilot study was under way in animals but now he is no longer at Geron it would be interesting to know the results.
I'm not assuming Frank is continuing to sell.
As an officer he had to make it public but now he isn't one so how do we know he isn't waiting for the news we want to hear and like us make a lot more money than selling now, especially if his volume of
selling would be enough to depress the sales price.
Right now I'm thinking our best chance for a near term catalyst is the FDA approval of the revised protocol since they are expected to respond within 30 days.
My guess is they looked at money on hand and time frame to advance GRN1005 through all the required levels of trials and decided Imetelstat, which they totally own was the only one they could afford to go with.
It would have been nice not to have wasted $40 million though.
He doesn't bother me since I put him on ignor when I first read a post of his. Nutjobs, pumpers and bashers all get ignor from me. He feeds off responses so don't even read his stuff.
Your point about all of the patients continuing in the trial even those who had not had a positive response YET may be worth observing.. Since the mechanism of action is intended to cause telomere shortening over time to the point of cell crisis I'll assume these non responders given more time for this attrition to occure may become responders and would increase the overall response rate. I'll be looking for that at ASH.
"2. 2 patients with 20/100 vision restored to 20/20 following RPE cell injection?"
Where did this news come from?
Since its an ETF there really isn't specific company news and programs to talk about like on individual stock boards, only big picture discussion and not sure if any of us can safely comment on which direction the whole sector is going. My thought is biotech ETF has more upside potential than downside and evens out the risk of individual biotechs, just like an index fund on the whole marketso here I am.
So I get an e-mail from PixarBio Investor relations informing me of the new company.
It appears they have access to NVIV's email address book for shareholders following the company.
I wonder if Frank took that file when he went out the door and whether NVIV was ok with that.
As long as we insist on the private sector taking basic research usually publicly funded and developing a therapy to sell to the market we will be faced with raising the enormous amount of money the current FDA process requires. We're spending 14 billion dollars on an aircraft carrier that a Chinese antiship ballistic missile may take out in the first minutes of conflict. But we can't find that kind of money to put into what looks like extremely promising
potential treatments that could benefit us all.
I like allof this.Astrue looks tostand up forthe best interests of the share holders, resists selling out if possibleand if not possiblestriving for the best deal only when the company's product is fully developed and looking for a bidding war by a number of potential buyers.
What happened with TKT smells like some inside dealing by the BOD costing the share holders a bundle.
Seems like NVIV could have included polymers to slow release dopamine/drugs for the treatment of Parkinson's Disease themselves? Franks "illness" appears to fall in the category of wanting to spend more time with one's family as a cop out.
All of Geron's hESC programs on the edge when the brakes hit.
VAC2 is particularly interesting to me.
Too bad we can't get a tech billionaire step up and start building his legacy by writing a blank check.