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26.03.2020

Covid-19: FDA Postpones Domestic and Foreign Inspections

In response to the COVID-19 outbreak, the U.S. Food and Drug Administration FDA has decided to postpone most foreign inspections until the end of April. This decision is already effective. However, foreign inspections (outside the U.S.) which are deemed critical will be considered on a case-by-case basis and might still be conducted.

FDA is aware that this might have an impact on other FDA responsibilities and activities, including product application reviews and product safety. Therefore, temporary tools will be employed to ensure the safety of products. Together with U.S. Customs and Border Protection, the aim is to prevent unsafe products from entering the US market. This can be supported by:

physical examinations and/or product sampling at the border,

reviewing a firm¡¦s previous compliance history,

using information sharing from foreign governments as part of mutual recognition and confidentiality agreements,

requesting records in advance of or in lieu of on-site drug inspections,

application of the risk-based import screening tool (PREDICT).

Meanwhile, FDA announced that all domestic routine surveillance facility inspections are temporarily postponed as well. Routine surveillance facility inspections are facility inspections that FDA conducts routinely every few years based on a risk analysis. However necessary domestic for-cause inspection will be evaluated and will proceed if mission-critical.

FDA continues to monitor this outbreak and the impact to its operations and stands ready to resume foreign inspections as soon as feasible.

Source: FDA Press Announcement

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Roswell Park to Assess Immunotherapy Combination in Cancer Patients With COVID-19

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The U.S. Food and Drug Administration has authorized clinical researchers at the center to conduct a study assessing the safety and effectiveness of giving both rintatolimod and interferon alfa to cancer patients with COVID-19, the disease caused by the novel coronavirus. The study is one of very few worldwide to repurpose an experimental cancer therapy as treatment for COVID-19.

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www.examinerlive.co.uk/news/west-yorkshire-news/bradford-doctor-leading-research-coronavirus-18226167

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Bradford is also one of just four centres in the UK researching the effects of Beta Interferon on coronavirus, in a study coordinated by the University of Southampton.

Beta interferon improves the immunity within the airwaves of the lungs against the Covid-19 virus so that it helps protect the people from coming to harm, explained Dr Saralaya.

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May 11th, 2020 at 3:24 PM

Stanford has a coronavirus therapy that might prevent severe cases

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Researchers at Stanford have a new coronavirus treatment idea: Giving patients who have been just diagnosed COVID-19 positive an interferon drug version within three days of the test.

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The trial is seeking 120 volunteers who haven¡¦t been admitted to a hospital after their positive diagnosis. They will be given either the drug or a placebo, and then they¡¦ll be monitored over nine successive visits.

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If successful, such protocols could speed up recovery and reduce the risk of life-threatening complications for patients who are healing at home.

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www.fool.com/investing/2020/05/08/why-protagonist-therapeutics-is-skyrocketing-today.aspx

......Protagonist Therapeutics argues that there is a significant unmet need for polycythemia vera. The company estimates that the indication currently offers a market opportunity between $1 billion and $2 billion in the U.S. and Europe. In other words, if PG-300 is approved for the treatment of polycythemia vera, Protagonist Therapeutics and its shareholders could be handsomely rewarded.

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An experimental trial of recombinant human interferon alpha nasal drops to prevent coronavirus disease 2019 in medical staff in an epidemic area

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Conclusion: We propose that type-I IFN deficiency in the blood is a hallmark of severe Covid-19 and could identify and define a high-risk population. Our study provides a rationale for testing IFN administration combined with adapted anti-inflammatory therapy targeting IL-6 or TNF-£\ in most severe patients. These data also raise concern for utilization of drugs that interfere with the IFN pathway.

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Dr James Liang - Overview of MPNs

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Overview of MPNs with a special focus on the use of pegylated interferon as a therapeutic option in the management of ET and PV.

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Interferon Treatment for Global Virus Outbreaks: SARS and COVID-19 (May 8, 2020)

Lurie Cancer Center & Hematology/Oncology Grand Rounds

Eleanor N. Fish, PhD, FAAS, University of Tortonto

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Condition or disease (For example: breast cancer)

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P2 Estimated Study Completion Date : November 1, 2022

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Phase 2 PTG-300 vs ¦w¼¢¾¯ ¤µ¤ÑPTG-300³s²Ä2´Á¤~°µ6­Ó¤H§A´N­nªì¨B¸Ñª¼¡H§Ú¯uªº¤£À´¡C

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PTG-300¬O­Ó¥Ö¤Uª`®g¤@©P¤@¦¸ÅK¶Pº¸»X¡uÅK½Õ¯À(hepcidin)¡vªºÃþ¦üª« (Hepcidin Mimetic)¡A®ÄªG¥Ø«e¬Ý¨Ó¥u¯à±±¨î¬õ¦å²y¼Æ(¦å¤ñ®e)¤Î¯e¯f¯gª¬¡A¦ýµLªk¸Ñ¨MPVªº¯e¯f¥»½è---bone marrow panmyelosis PV¯f¤Hªº°©Åè¤Á¤ù¯S©Ê¡A¤]¬O2016WHOªº½T¶E¼Ð·Ç¡A´N¬O¥þ²Ó­M¨t(¬õ¦å²y¡A¥Õ¦å²y¡A¦å¤pªO)¼É¼W¡A²³æ¨Ó»¡¤Á¤ù¤U´N¬O°©ÅèÀ½¤F¤@°ï²Ó­M¡F¦ÓHU¡A¤@­Ó§í¨îDNA¡F¤zÂZ¯À¡A¥»¨Ó´N¦³°©Åè§í¨îªº®ÄªG¡A¨Ã¯àªø´Á§í¨îÅܲ§jak2³y¦å·F²Ó­M¡F³o¨â­Ó¥Ø«eªº²Ä¤@½u¥ÎÃĤ£½×ÃIJz¾÷Âà³£«Ü¦X²z¡APTG-300¦pªG­nªvÀø°ª­·ÀIªºpv¡A­n¸ò³o¨â­ÓÃÄ«~¤ñ¹F¨ìsuperiority¡AÃø«×«D±`¤§°ª¡C¥ú¨â­ÓPV±`¨£¯gÀYPV¦X¨Ö¥Õ¦å²y¹L¦hleukocytosis©Î¦X¨Ö¦å¤pªO¹L°ªthrombicytosis ´N¥Ø«eµ²ªG¦Ó¨¥¡A§¹¥þ¨S¦³²z¥Ñ¨Ï¥ÎPTG-300¶i¦æªvÀø¡C

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³Ì«á·íµM¡AÀ°¥L»¡ÂI¦n¸Ü¡A¯à§ä¨ìRonald Hoffman, M.D., Director of the Myeloproliferative Diseases Program at The Icahn School of Medicine at Mount SinaiÀ°¥L°µ¬ã¨s¡A¬OÁÙº¡°÷¤O¡AÃĤ]¥i¯à°÷¦³¼ç¤O¡C

³o¦ìRonald Hoffman¬O½Ö©O¡H´N¬O¶i¦æ©µªø«¬¤zÂZ¯ÀPegasys vs HUªvÀøPVªº²Ä¤T´ÁÁ{§É¸ÕÅç(¹ï¡A¥@¬É¤W°£¤FÃĵØAOP¥u¦³¥L°µ¤F²Ä¤T´Á¡AÁÙ¬O¦Û¤v©Ôªº¬ã¨s¸g¶O¡A«Dù¤ó¥X¸ê)ªº³Ã¥ë¡A¬ã¨s¦WºÙMPD-RC 112¡Aµ²ªGªvÀø´Á¶¡2¦~(ª`·N¥u¦³2¦~)¡A©MHU¤£¬Û¤W¤U¡F¥t¥~ÁÙ°µ¤FMPD-RC 111¡AÃҹꩵªø«¬¤zÂZ¯ÀPegasysªvÀø¹ïHU²£¥Í§ÜÃĩʪº¯f¤H¡A¹ï§A¨S¬Ý¿ù¡A´N¬O®³¤zÂZ¯À°µ¤F2½u¥ÎÃĪº¬ã¨s¡Aµ²ªG¤£½×PVÁÙ¬OET³£¦³¦nªºÀø®Ä¡C

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news.cancerconnect.com/myeloproliferative-neoplasms-mpn/mpn-rc-112-clinical-trial-fails-to-confirm-interferon-superiority-in-pv-and-et-yubSjvw-Dkyv4eTp5hv1pA

¥H¤W¤p§Ì²L¨£ ·íµM§Ú¤]·Q¶R¨ìötªÑ....¦ý¬Ý¨Ó³o¤äPTGX­·ÀI¬Æ°ª¡A¤§«e¤]´¿¨ì14¶ô¡A¦b4­Ó¦h¤ë«á¤S¶^¨ì3.97¡A¦A¨Ó¬Ý¤§«áµo®i§a

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·|­û¡G¤p¥¿¥¿10141351  µoªí®É¶¡:2020/5/9 ¤U¤È 09:45:44²Ä 8596 ½g¦^À³
www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31042-4/fulltext

Triple combination of interferon beta-1b, lopinavir¡Vritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial

¤zÂZ¯À£]-1b¡A¬¥¤Ç¨º­³¡V§Q¦«¨º­³©M§Q¤Ú­³ªLªº¤TÁp²Õ¦XªvÀøCOVID-19¦í°|±wªÌ¡G¤@¶µ¶}©ñ¼ÐÅÒ¡AÀH¾÷¡A2´Á¸ÕÅç

Published:May 08

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Summary

Background

Effective antiviral therapy is important for tackling the coronavirus disease 2019 (COVID-19) pandemic. We assessed the efficacy and safety of combined interferon beta-1b, lopinavir¡Vritonavir, and ribavirin for treating patients with COVID-19.

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¦³®Äªº§Ü¯f¬rªvÀø¹ï©óÀ³¹ï2019¦~«aª¬¯f¬r¯f¡]COVID-19¡^¤j¬y¦æ¦ÜÃö­«­n¡C§Ú­Ìµû¦ô¤FÁp¦X¤zÂZ¯À£]-1b¡A¬¥¤Ç¨º­³¡V§Q¦«¨º­³©M§Q¤Ú­³ªLÁp¦XªvÀøCOVID-19±wªÌªºÀø®Ä©M¦w¥þ©Ê¡C

Methods

This was a multicentre, prospective, open-label, randomised, phase 2 trial in adults with COVID-19 who were admitted to six hospitals in Hong Kong. Patients were randomly assigned (2:1) to a 14-day combination of lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin 400 mg every 12 h, and three doses of 8 million international units of interferon beta-1b on alternate days (combination group) or to 14 days of lopinavir 400 mg and ritonavir 100 mg every 12 h (control group). The primary endpoint was the time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT-PCR, and was done in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT04276688.

¤èªk

³o¬O¤@¶µ°w¹ïCOVID-19¦¨¤Hªº¦h¤¤¤ß¡A«e¤©Ê¡A¶}©ñ¼ÐÅÒ¡AÀH¾÷¡A2´ÁÁ{§É¸ÕÅç¡A¤w³Q­»´ä¤»®aÂå°|¦¬ªv¡C±wªÌ³QÀH¾÷¤À°t¡]2¡G1¡^¡A¨C12¤p®ÉªA¥Îlopinavir 400 mg©Mritonavir 100 mg¡A¨C12 h§Q¤Ú­³ªL400 mg¡A¨Ã¦b¹j¤éªA¥Î¤T¾¯800¸U°ê»Ú³æ¦ì¤zÂZ¯Àªº14¤Ñ²Õ¦X¡]¦X¨Ö²Õ¡^©Î¨C12¤p®ÉªA¥Î14¤Ñªºlopinavir 400 mg©Mritonavir 100 mg¡]¹ï·Ó²Õ¡^¡C¥D­n²×ÂI¬O¬°ÄY­««æ©Ê©I§l¨t²Îºî¦X¯g«aª¬¯f¬r2 RT-PCR´£¨Ñ»ó«|«ø¤l³±©Êªº®É¶¡¡A¨Ã¦b·N¦V©ÊªvÀø¤H¸s¤¤§¹¦¨¡C¸Ó¬ã¨s¤w¦bClinicalTrials.govµù¥U¡ANCT04276688¡C

Findings

Between Feb 10 and March 20, 2020, 127 patients were recruited; 86 were randomly assigned to the combination group and 41 were assigned to the control group. The median number of days from symptom onset to start of study treatment was 5 days (IQR 3¡V7). The combination group had a significantly shorter median time from start of study treatment to negative nasopharyngeal swab (7 days [IQR 5¡V11]) than the control group (12 days [8¡V15]; hazard ratio 4¡P37 [95% CI 1¡P86¡V10¡P24], p=0¡P0010). Adverse events included self-limited nausea and diarrhoea with no difference between the two groups. One patient in the control group discontinued lopinavir¡Vritonavir because of biochemical hepatitis. No patients died during the study.

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2020¦~2¤ë10¤é¦Ü3¤ë20¤é¡A©Û¶Ò¤F127¦W±wªÌ¡F±N86­ÓÀH¾÷¤À°t¨ì²Õ¦X²Õ¡A±N41­Ó¤À°t¨ì¹ï·Ó²Õ¡C±q¯gª¬µo§@¨ì¶}©l¬ã¨sªvÀøªº¤¤¦ì¼Æ¤Ñ¼Æ¬O5¤Ñ¡]IQR 3-7¡^¡C²Õ¦X²Õ±q¬ã¨s¶}©lªvÀø¨ì»ó«|«ø¤l³±©Êªº¤¤¦ì®É¶¡¡]7¤Ñ[IQR 5-11]¡^©úÅãµu©ó¹ï·Ó²Õ¡]12¤Ñ[8-15]¡F¦MÀI¤ñ4¡P37 [95¢HCI] 1¡P86¡V10¡P24]¡Ap = 0¡P0010¡^¡C¤£¨}¨Æ¥ó¥]¬A¦Û­­©Êäú¤ß©M¸¡Âm¡A¨â²Õ¤§¶¡µL®t²§¡C¹ï·Ó²Õ¤¤ªº¤@¦W±wªÌ¥Ñ©ó¥Í¤Æ¨xª¢¦Ó°±¥Î¤F¬¥¤Ç¨º­³¡V§Q¦«¨º­³¡C¬ã¨s´Á¶¡¨S¦³±wªÌ¦º¤`¡C

Interpretation

Early triple antiviral therapy was safe and superior to lopinavir¡Vritonavir alone in alleviating symptoms and shortening the duration of viral shedding and hospital stay in patients with mild to moderate COVID-19. Future clinical study of a double antiviral therapy with interferon beta-1b as a backbone is warranted.

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www.biospace.com/article/releases/protagonist-therapeutics-announces-initial-phase-2-results-with-hepcidin-mimetic-ptg-300-in-the-treatment-of-polycythemia-vera/

Protagonist Therapeutics Announces Initial Phase 2 Results with Hepcidin Mimetic PTG-300 in the Treatment of Polycythemia Vera

NEWARK, Calif., May 7, 2020 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced initial data from the ongoing Phase 2 study of PTG-300 in patients with polycythemia vera.

finance.yahoo.com/news/why-did-protagonist-therapeutics-ptgx-212309643.html

CEO Dinesh V. Patel said the company is focused on ¡§rapidly advancing¡¨ PTG-300 and deferring the start of an ulcerative colitis candidate¡¦s Phase 2 study. This will help reduce expenses and extend its cash pile another 6 months through mid-2022.

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Anti-viral drug trio found to shorten COVID-19 illness in mild cases: study

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by Kelly MACNAMARA Agence-France Presse9 May 2020

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Researchers in Hong Kong have found that patients suffering milder illness caused by the new coronavirus recover more quickly if they are treated with a three-drug antiviral cocktail soon after symptoms appear.

Authors of the study, published in the Lancet on Friday, described the findings as early but important.

They called for larger-scale research on critically-ill patients to ascertain if the drug combo could be a viable treatment for them too.

Our trial demonstrates that early treatment of mild to moderate COVID-19 with a triple combination of antiviral drugs may rapidly suppress the amount of virus in a patient¡¦s body, said Kwok-Yung Yuen, professor at the University of Hong Kong, who led the research.

He said the treatment, which appeared safe in patients, was shown to relieve symptoms, and reduce the risk to health-care workers by reducing the duration and quantity of viral shedding (when the virus is detectable and potentially transmissible).

Scientists are racing to identify effective medicines to use against the new coronavirus, but there is currently no treatment, cure or vaccine.

The study tracked the virus in 127 adults admitted to six hospitals in Hong Kong after they tested positive.

Of those participating, 86 patients were given a two-week course of three medicines: interferon beta-1b, a drug used to treat multiple sclerosis; HIV drugs lopinavir-ritonavir; and ribavirin, used to treat hepatitis.

A randomly-assigned control group of 41 people was just given the lopinavir-ritonavir combination.

Treatment began on average five days after symptoms started and all patients otherwise received standard care, including oxygen therapy.

Researchers then measured how long it took for a swab test for the virus to turn out negative.

They found that those taking all three medicines were able to clear the coronavirus in seven days on average (between five and 11 days) -- significantly shorter than the 12-day average for the control group.

Those on the three-drug regimen also saw a complete alleviation of their symptoms in an average of four days, compared to eight for the control group.

The study was carried out between February 10 and March 20 in Hong Kong, where everyone who tests positive for COVID-19 is admitted to hospital.

The authors conceded several limitations with the trial, including that it was open label -- people knew which drugs they were taking and there was no placebo.

Also, patients admitted more than seven days after the onset of symptoms were not given interferon because of concerns that it could cause inflammation.

Of these, 34 were given the combination of lopinavir-ritonavir and ribavirin, while 17 were in the control group.

Both of these groups took equally long to clear the virus which, the authors suggested, meant that interferon was key to the shorter illness for the patients treated from the first week of symptoms.

Future clinical study of a double antiviral therapy with interferon beta-1b as a backbone is warranted, the study said.

Reacting to the study, Stephen Evans, Professor of Pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said it justifies the consideration of adding interferon beta to the list of genuinely, evidence-based, promising treatments to be tested in further randomised trials.

It has been clear from long experience that HIV is best treated with combinations of different drugs and this could also be the case with COVID-19, he added.

Everyone who tests positive for the virus is admitted to hospital in Hong Kong

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BetterLife Pharma Enters into a Licensing Agreement

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ANCOUVER , May 7, 2020 /CNW/ - BetterLife Pharma Inc. (BetterLife or the Company) (CSE: BETR / OTCQB: PVOTF / FRA: NPAT) today announced that it has entered into an agreement to acquire worldwide rights (other than in Greater China , Japan and ASEAN countries) to commercialize and sell AntiCovir, a potential COVID-19 treatment, from Altum Pharmaceuticals Inc. (Altum). AntiCovir is an Interferon a2b (IFNa2b ) based potential treatment that is proposed to be administered using a Metered Dose Inhaler (MDI) or a nebulizer. Altum is currently preparing protocol and application to conduct a 306 patient randomized, double-blind, placebo controlled, powered for Phase 3 registration clinical trials in Australia . Subject to regulatory approvals, the clinical trials in Australia could begin as early as July 2020 . Under the terms of the transaction, on closing BetterLife will issue 10,000,000 common shares to Altum and grant to Altum 5,000,000 warrants to acquire an equivalent number of common shares at a price of $0.19 per common share. The Warrants have a term of two years and are only exercisable upon successful completion of the Phase 3 trial.

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www.onclive.com/onclive-tv/dr-michaelis-on-the-role-of-interferon-in-mpns

youtu.be/64qvf-fCJg0

Dr. Michaelis on the Role of Interferon in MPNs

Laura C. Michaelis, MD

Published: Monday, May 04, 2020

Laura C. Michaelis, MD, associate professor, Medical College of Wisconsin, discusses the role of interferon in myeloproliferative neoplasms (MPNs).

Hydroxyurea is a common treatment arm in randomized trials in polycythemia vera and essential thrombocythemia, says Michaelis. However, interferon has seen an uptick in utility for patients with JAK2-positive MPNs. Notably, data suggests that interferon can lessen a patient¡¦s molecular mutation burden.

The National Comprehensive Cancer Network guidelines have indicated interferon as an appropriate frontline treatment for some patients with MPNs, says Michaelis.

Interferon may be better tolerated in younger patients with MPNs, explains Michaelis. Moreover, interferon is less likely to cause fertility-related adverse events in patients.

In terms of long-term treatment considerations, it is important to remember that hydroxyurea is associated with skin toxicities, explains Michaelis.

Pegylated interferon is well tolerated and should be considered in the up-front treatment of patients with MPNs, concludes Michaelis

«Â´µ±d¬P¦{Âå¾Ç°|°Æ±Ð±ÂÅÚ©Ô¡P¦Ì®L¸Ì´µ(Laura C. Michaelis)°Q½×¤F¤zÂZ¯À¦b°©Åè¼W´Þ¸~½F(MPN)¤¤ªº§@¥Î¡C

Michaelis»¡, HUßm°ò§¿¯À¬OPV¦hÅn¦å¯g©MET¥²»Ý¦å®ê¦å¯gÀH¾÷¸ÕÅ礤±`¨£ªºªvÀø¤è¦¡¡CµM¦Ó,¤zÂZ¯À¹ïJAK2¶§©ÊMPN±wªÌªº®Ä¥Î¦³©Ò¤W¤É¡C ­È±oª`·Nªº¬O,¼Æ¾ÚÅã¥Ü¤zÂZ¯À¥i¥H´î»´±wªÌªº¤À¤l¬ðÅÜ­t¾á¡C

Michaelis»¡,°ê®aÀù¯gºî¦Xºô¸ô«ü«nªí©ú¤zÂZ¯À¬O¤@¨ÇMPN±wªÌªº¤@ºØ¾A·íªº«e½uªvÀø¡C¦Ì®L¸Ì´µ¸ÑÄÀ»¡,¤zÂZ¯À¦bMPNªº¦~»´±wªÌ¤¤¥i¯à­@¨ü©Ê§ó¦n¡C¦¹¥~,¤zÂZ¯À¤£¤Ó¥i¯à¾É­P±wªÌ»P¥Í¨|¦³Ãöªº¤£¨}¨Æ¥ó¡C

Michaelis¸ÑÄÀ»¡,±qªø´ÁªvÀø¦Ò¼{¨Ó¬Ý,­«­nªº¬O­n°O¦íßm°ò§¿¯À»P¥Ö½§¬r©Ê

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Note:

Dr. Laura Michaelis

patientpower.info/bio/laura-c-michaelis-md/

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Laura Michaelis ¤]¬O2019 MPN ­^¶¯º]¤§¤@­û³á (¹ï«Ü¦hMPN »â°ìÀ³¸Ó¤]¬O±`±`¬Ý¨ìªº·N¨£»â³S¤§¤@)

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