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Re: KPTI

By: Decomposed in POPE 5 | Recommend this post (0)
Tue, 21 Apr 20 2:01 AM | 40 view(s)
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I bought Karyopharm for its cancer treatment. Today it announced its COVID-19 study. It's currently a 3-bagger and will go up a lot more if the test is successful.
April 20, 2020

Karyopharm Announces Dosing of First Patient in Randomized Study Evaluating Low Dose Selinexor in Patients with Severe COVID-19

by finance.yahoo.com

NEWTON, Mass., April 20, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (KPTI) today announced dosing of the first patient in a randomized Phase 2 clinical study evaluating low dose oral selinexor in hospitalized patients with severe COVID-19. This global study is expected to enroll approximately 230 patients at clinical sites in the U.S., Europe, and Israel. Selinexor is an oral selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1 which is involved in both the replication of SARS-CoV-2, the virus that causes COVID-19, and in the inflammatory response to the virus.

The randomized, multi-center, placebo-controlled Phase 2 study (XPORT-CoV-1001/NCT04349098 ) of low dose selinexor is designed to assess the activity and safety of 20mg of selinexor given orally three times a week for two weeks. Patients tolerating therapy well and experiencing clinical benefit may be eligible to continue treatment for an additional two weeks at the discretion of the treating physician. The primary endpoint of the study is time to clinical improvement based on improvement in the Ordinal Scale, consistent with the COVID-19 trial recommendations by the World Health Organization and the U.S. Food and Drug Administration (FDA). Additional secondary endpoints in the study include the overall death rate at day 28 as well as the rate of, and time to, mechanical ventilation.

“In less than two weeks since announcing our intention to study selinexor in patients with severe COVID-19, we have quickly mobilized our team to activate clinical trial sites across the globe and are proud to announce the dosing of the first patient in our randomized study,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. “This important milestone marks the first study of an XPO1 inhibitor in patients with severe viral infections. We remain highly encouraged by the potential anti-viral and anti-inflammatory activity of XPO1 inhibition with selinexor and look forward to working with the medical community of regulators, treating physicians and patients on advancing this important study as quickly as possible.”

SINE compounds have been identified as having the potential to interfere with key host protein interactions with influenza, RSV and other viruses including SARS-CoV-2.1 Furthermore, XPO1 (also called CRM1) was identified as one of the host proteins with the highest number of functional connections with SARS-CoV proteins.2 Finally, SINE compounds, including selinexor, have demonstrated potent anti-inflammatory activity through the inhibition of Nuclear Factor kB (NF-kB), leading to reductions in cytokines such as IL6, IL1, IFNg and others in a variety of models, which may be particularly beneficial to hospitalized patients with COVID-19 and other severe viral infections.

“In my laboratory, we have now used two different approaches to investigate selinexor’s ability to inhibit the viral propagation of the SARS-CoV-2 virus in Vero cells, which are monkey cells commonly used in modeling human viral infections. In our first experiment, with the assistance of Jackelyn Murray in my lab, we demonstrated that selinexor inhibited the production of new virus by 90% at a low concentration (100 nM) from cells that were already infected with SARS-CoV2. This is very exciting as low oral doses of selinexor are expected to deliver levels over 300 nM. In the second experiment, we showed that even lower levels of selinexor, only 10nM, could reduce the ability of the virus to infect new cells by about 99%. I am highly encouraged by these results and thrilled to see how quickly Karyopharm is able to test these scientific findings in patients so dramatically impacted by the current COVID-19 pandemic,” said Ralph Tripp, PhD, a Georgia Research Alliance Eminent Scholar and Professor in the Department of Infectious Diseases in the College of Veterinary Medicine at the University of Georgia.”

Selinexor, marketed as XPOVIO®, is currently approved at higher doses by the FDA as a treatment for patients with relapsed or refractory multiple myeloma. Selinexor is currently the only XPO1 inhibitor approved for commercial use by the FDA and has been extensively tested in clinical trials across numerous cancer indications worldwide since 2012. Karyopharm has sufficient supply of selinexor for current and expected commercial patients with multiple myeloma, for ongoing clinical trials in patients with various cancers, as well as for this study in patients with COVID-19.

http://finance.yahoo.com/news/karyopharm-announces-dosing-first-patient-110010920.html




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Gold is $1,581/oz today. When it hits $2,000, it will be up 26.5%. Let's see how long that takes. - De 3/11/2013 - ANSWER: 7 Years, 5 Months

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The above is a reply to the following message:
Re: KPTI
By: Decomposed in POPE 5
Tue, 03 Mar 20 1:49 AM 		Msg. 54065 of 62138

March 2, 2020

This Biotech Stock Broke Out As A Cancer Drug 'Transforms' Its Story

by ALLISON GATLIN,Investor's Business Daily


This Biotech Stock Broke Out As A Cancer Drug 'Transforms' Its Story

Karyopharm Therapeutics (KPTI) unveiled promising results for a late-stage cancer treatment on Monday — prodding KPTI stock to rocket and break out.

The biotech company studied a regimen of three drugs in patients with multiple myeloma, a type of blood cancer. In the Phase 3 study, patients who received the regimen survived without progressing for a median 4.47 months longer than those given a two-drug combination.

Analysts are bullish on Karyopharm and a key drug in the regimen, Xpovio. RBC Capital Markets analyst Brian Abrahams said the news "transforms" the story around KPTI stock. He reiterated his outperform rating on KPTI stock.

"We continue to see significant opportunity for (Xpovio), not fully appreciated in Karyopharm's valuation," he said in a note to clients. "We model $200 million-plus global sales opportunity for (Xpovio) in its existing late-late multiple myeloma indication."

On the stock market today, KPTI stock soared 69.7%, 27.72, in massive volume.

KPTI Stock Rockets On Test Results

Specifically, Karyopharm tested a regimen of Xpovio, Takeda Pharmaceutical's (TAK) Velcade and a drug called dexamethasone. Patients took the regimen once a week. Their results were tested against a group of patients taking Velcade and dexamethasone twice a week.

Both groups of patients had received one to three prior cancer treatments for multiple myeloma.

At the median, patients on the three-drug regimen survived for 13.93 months without worsening symptoms. Patients taking the two-drug cancer treatment — the standard of care — survived for a median 9.46 months before worsening.

The three-drug cancer treatment also proved to be safe, which is a boon for KPTI stock.

"Overall, the positive (study called Boston) is in line with our expectations, although we'll wait for a presentation of the results at an upcoming medical meeting for more study details," SVB Leerink analyst Jonathan Chang said in his report to clients.

He boosted his price target on KPTI stock to 30 from 22, and kept his outperform rating.

Cancer Treatment Could Expand Sales

Next, Karyopharm plans to ask regulators in the U.S. and Europe to approve the use of the three-drug cancer treatment regimen. If approved, it would be the only combination that includes once-weekly Velcade for relapsed multiple myeloma, Karyopharm says.

Xpovio already has Food and Drug Administration approval to treat multiple myeloma in patients who've received at least four prior cancer treatments. The current market for Xpovio in this patient group is about 6,000 people, Karyopharm said in an email to Investor's Business Daily.

This new cancer treatment regimen would increase the patient population to about 32,000, the biotech company said.

"Karyopharm is also the first 'small' pharmaceutical company to develop and gain approval for a drug in the treatment of refractory multiple myeloma, and competes against much larger pharma companies," the biotech company said.

Other companies targeting multiple myeloma include Takeda, Amgen (AMGN), Bristol-Myers Squibb (BMY)-owned Celgene and Johnson & Johnson (JNJ). Xpovio was the first new drug for multiple myeloma to gain FDA approval since 2015.

Notably, results of the study Monday helped KPTI stock to surge above a buy point at 20.19 out of a consolidation. Shares of KPTI stock have a best-possible Relative Strength Rating of 99. The RS Rating tracks a stock's 12-month performance.

http://www.investors.com/news/technology/kpti-stock-rockets-cancer-treatment-passes-muster/?src=A00220&yptr=yahoo

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