This has been described as potentially being better than Pacira's(PCRX)'s medication. Although early in development, it could be a big +. Any thoughts from the board?
In my opinion as a hematologist, the induction RR is not overwhelming. Scads of studies have had slightly favorable RR, but failed on the more CRUCIAL criteria of OS.The key issue is whether the OS data, if +, will be really clinically meanigful, rather then just statistically significant. I own a little, but wouldn't bet the farm.,
NEWTOWN, Pa., Dec. 07, 2015 (GLOBE
NEWSWIRE) -- Onconova Therapeutics,
Inc. (ONTX), a clinical-stage biopharmaceutical
company focused on discovering and
developing novel products to treat cancer,
today announced the enrollment of the first
patient in the INSPIRE trial for IV rigosertib
as a treatment for higher-risk myelodysplastic
syndromes (HR-MDS) after failure of
hypomethylating agent (HMA) therapy.
"There is a significant unmet medical need
in patients who have failed treatment with an HMA, the only available therapy for HRMDS,”
said Dr. Guillermo Garcia-Manero, lead investigator for the INSPIRE trial and Chief
of the Section of Myelodysplastic Syndromes at The University of Texas MD Anderson
Cancer Center. “In previous clinical studies, rigosertib demonstrated positive results in
HR-MDS patients with very poor prognosis. The INSPIRE trial is designed to assess the
effects of IV rigosertib in these HR-MDS patients who have a short life-span and no effective
therapies currently available.”
The INSPIRE trial is a global, multi-center, randomized controlled study to assess the efficacy
and safety of IV rigosertib in HR-MDS patients under 80 years of age who had progressed
on, or failed to respond to, or relapse after previous treatment with HMAs. The
trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment
arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive
Care. The primary endpoint of INSPIRE is overall survival and an interim analysis
Clinical Trial Applications (CTAs) and/or site initiation activities for INSPIRE have begun in
You have to be patient. The ph3 study, which has just started, for a "derisked" group of patients with myelodysplastic syndrome,, has a high likelihood of being successful. They have selected the group of patients who had the best response in ph2 for the ph3 study, and this is what I mean about being derisked. The study chairman is the head of the Myelodysplastic Section at MD Anderson, probably the best cancer hospital. and he spoke enthusiastically about the ph2 data after the presentation at ASH 2015.The company has strong support from Baxalta,,so I don't think you have to worry about bankruptcy.
article in SA today that rlyp has big advantage over Zy.. because it is free of sodium while Z adds a significant
amount of sodium to a population of patients in whom it could have an adverse effect due to rise in BP. Can anyone provide an authoritative comment?
I would listen to their presentation tonight before passing judgment. The whole biotech sector has tanked today, although I agree KPTI a little more then the rest of my holdings
The key point from FDA is that CVOT w\ill NOT be required for approval! Docs are highly likely to use this ORALl drug, whicht will have a much lower price then Praulent or Repatha off label for the larger market of primary prevention.
One of the greatest challenges in treating patients with AML is the very low white count which is almost always present; the low white count markedly increases the risk of sepsis. It is certainly no surprise that a further reduction in white blood count APPARENTLY caused by selinexor would lead to an increase in the incidence of sepsis. The numbers involved are very, and this may turn out to be a statistical fluke. In any case, it was very appropriate for KPTI tto reduce the dose, Keep in mind that the outlook for patients with AML, particularly, ederly patients, is very poor. There has been no significant improvement in the treatment for AML in over 30 years and there is clearly a very large unmet need. I don't believe that the reduction in seliexor dosage is a major problem in the development of the drug. The huge drop in the price of the stock appears to me to make it a compelling buy, which I have done. It is not uncommon for adjustment of dosage in phase 1/2 studies and this is the exact purpose for early phase trials. The huge unmet need for a new drug for AML is likely to make the FDA more willing to accept a drug with even small improvement of the outcome for patients with AML
It is a shame that the FDA decided to make a "case" out of Valor. The entire study of all age groups just barely missed statical significance, and the benefit in pre-defined sub-groups patients 60 and patients with resistant disease or early relapse is quite clear. Personally, I see nothing wrong with pre-defined sub-group analysis. In fact, Novartis got approval for paninobast for multiple myeloma despite a negative review by the physician review panel. Nonetheless. what is done is done. However,I think it is highly likely that vosaroxin will be approved in the EU and Japan where this more consideration of the totality of resuts. EU and Japan are not an insignificant market. Vosaroxin is also being studied in the US by very prominent investigator initiated trials for front line therapy of AML and myelodysplastic syndrome. So there is still hope for a US approva in other indications then relpsed AML l. In addition, SNSS has a drug which looks pretty good as a pan Raf inhibitor for solid malignancies. Now at a market cap of $75 mil, I thin SNSS represents a good speculation.
The company released the secondary endpoint ON SCHEDULE- I don't know if they were trying to pump up share price.
Yes, I can and will recommend this stock, which is priced for failure on primary end point when in fact the chances of success are quite high. Keep in mind that the company picked the group with the best response, secondary AML, in two ph 2 studies. Furthermore, as indicated in the press release, remission rate is highly correlated with PFS and OS data.
Despite great advances in several hematologic malignancies such as CML, CLL, multiple myeloma and lymphomas, there has been no significant improvement in AML therapy in over 30 years. CPX-351 holds
orphan drug status and has fast track designation from the FDA, and the study has been supported by the Leukemia and Lymphoma Society. Even if the OS data in early 2016 fails to be +, I think the drug still stands a good chance of gaining approval based on the improved rate of CR. so far demonstrated. CR is needed to perform bone marrow transplant, which if successful, offers the best chance for a durable remission in AML. The drug could certainly garner a few hundred mil in revenue per year, which would be huge for this company with such a tiny market cap..
Also keep in mind that Heron has a second CINV drug, HTX-019, in clinical development. The company says HTX-019 could be submitted for approval in the second half of 2016. Heron is also working on a post-surgical pain drug, HTX-011, which is likened to Pacira Pharmaceuticals' (PCRX) commercially successful Exparel. I spoke with one significant investor in Heron who believes HTX-011 is the company's "sleeper hit" pipeline product.
Significantly improved response rate and overall survival in 60 with refractory disease or early relapse seems assured based on data from EHA, and the drug almost certainly will be used in off label cases as well.
Food distributor Sysco Corp said on Friday that a record U.S. outbreak of avian flu would limit its chicken and egg supply for nine to 18 months, based on information provided to the company by its suppliers.
Sysco is the biggest U.S. food distributor, whose clients include restaurants, hotels and hospitals. The company is discussing options with its customers, including creating alternative menu items during the period, a Sysco spokesman said in an email.
It is too soon to tell whether the supply squeeze will have a material impact on financial results, spokesman Charley Wilson said. Poultry accounted for 10 percent of Sysco's revenue in 2014, according to filings.
Read MoreNebraska declares state of emergency over bird flu
The U.S. poultry and egg industry is grappling with the country's biggest outbreak on record of avian influenza, which has proven highly infectious and deadly for poultry. Governors in Nebraska, Wisconsin, Minnesota and Iowa have declared a state of emergency, and the outbreak has shown few signs of waning.
Earlier this week, Cargill Inc said it has implemented increased biosecurity measures at its facilities receiving liquid egg tankers and shell eggs from impacted states and that it is working with egg suppliers to ensure they are employing measures to prevent spread of the flu.
Meanwhile, on Thursday, Post Holdings Inc, calling the flu a "force majeure event," said it now estimates that 25 percent of its egg supply has been affected. Sysco is a major customer for Post's Michael Foods business, which sells egg products, according to filings.
Stifel Nicolaus analyst Christopher Growe expects Post's previous estimate of a $20 million financial impact in 2015 to at least double, according to a research note.
Growe said that Post's contracts require the company to go to the open market and to third parties to replace the lost supply at high prices. "We believe that by declaring force majeure, the company will be able to either pass higher
Yes, I think there is an excellent chance that the FDA will approve for elderly AML. In fact, I am optimistic that the filing will get fast track status. There is a compelling need for new Rx.
I think that the pipeline of early stage drugs is under appreciated.