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Spideyboy, you wrapped it up realistically
and very professionally.
Small wonder the sp is stuck where it is now.
My hope, perhaps more of a wishful thinking,
is that some BP will step forward with funds
thus avoiding near term dilution.
Time will tell.
Thank you for your learned opinion.
That would of course be something different entirely :)
Hi again Midas,
Regards this PR, I don't think there is anything new or particularly interesting to glean from it.
The key point in the PR is:
"Dr. Papp who is leading the design of Can-Fite’s pivotal Phase III psoriasis registration trial, which will be submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for market clearance of Piclidenoson in the treatment of moderate to severe psoriasis."
On this there are 2 things to see.
1. They are clearly designing the new Phase 3 Psoriasis study with Dr. Papp. So we are years off from getting an outcome on the psoriasis situation.
2. They appear to be stuck with their beefed up previous PR wording where to calm and I dare say confused sentiment, they keep adding in buzz wording about registration trial and submission to FDA and EMA to keep people thinking they are moving ahead with some sort of speed. However as we know this is not the case. First they will design, then recruit then get data read out, all of which will take years and plenty more money to get there in this indication.
The liver cancer study, while still being at least a year off, is the closest thing I see on the horizon.
If only USA would replace Romania for
the Compassionate Use Treatment,
the impact on sp would have been tenfold
or at least sparked some attention to a
would be BP parntership.
Hi Midas,
Thanks for bringing this to my attention.
Indeed a positive news day for CANF.
And while I don't want to take anything away from this, I still feel the company is a long way off.
We know that they are recruiting for a pivotal phase 3 trial for this Child Pugh B Liver cancer group, and they they need to run another "pivotal" study in the psoriasis indication.
It seems a key reason for Romania to have approved this for compassionate use is that it was one of their own citizens in the prior trial that achieved a complete response and therefore is going to stay on the drug. It would make sense for Romania to do this to keep that citizen alive and thus blanket compassionate approve in the country.
This said however, and as mentioned in the PR, compassionate use has already been in effect in Israel for some time. Thus with rather little or almost no revenues from Isreal despite it being compassionate use for many years, we can assume that this addition of Romania will not translate to any meaningful revenues either.
Thus while I am indeed happy for those in Romania that will now be able to take the product, I still feel the CANF is still running out of cash quickly and will need to dilute by end of year.
I fully believe in their products to have a place in the market, the issue is just that management has an uncanny ability to design the clinical studies in such a away that they fail the primary endpoint(s) making progress difficult. Snatching defeat from the jaws of victory as it were.
I will of course continue to follow all developments with CANF :)
Honestly speaking, i cannot decipher
this company although i am quite
deeply invested in it!
Hopefully one day.........
That’s Two drugs on phase-3 for a rather small biotech. Can’t believe it’s still trading at this level.
IMO
Hi Spideyboy:
$CANF,
Every day a news day!
Nice, very nice!
Can-Fite’s Drug Namodenoson Approved for Compassionate Use Treatment of Advanced Liver Cancer Patients in Romania
https://finance.yahoo.com/news/fite-drug-namodenoson-approved-compassionate-110000142.html
Namodenoson induced a complete response with disappearance of all metastases in a patient who will now continue the treatment under a compassionate use program in Romania
Can Fite’s Phase III pivotal study is open for patient enrolment
PETACH TIKVA, Israel, August 23, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today its liver drug candidate Namodenoson has been approved for compassionate use for the treatment of patients with advanced liver cancer in Romania. Namodenoson was previously approved for compassionate use in Israel, where advanced liver cancer patients have been treated for several years.
In parallel, Can-Fite’s pivotal Phase III study in patients with advanced liver cancer (hepatocellular carcinoma), is open for patient enrolment and will recruit patients in Israel, the U.S., and five countries in Europe. This pivotal study received a ‘green light’ to proceed from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and if successfully concluded, the Company will be in a position to submit the drug for approval with each of the regulatory authorities. Namodenoson has Orphan Drug Status with both the FDA and EMA and Fast Track Status with the FDA. A registration plan has been submitted to and accepted by the FDA.
"We are committed to providing Namodenoson, with an excellent safety profile and strong efficacy in this patient population in clinical trials to date, to fulfill an urgent unmet medical need. The anti-cancer effect of Namodenoson together with its liver protective properties make it unique among anti-cancer drugs for this devastating disease," stated Can-Fite CEO Dr. Pnina Fishman.
The hepatocellular carcinoma (HCC) drug market is expected to reach $3.8 billion in 2027 in the G8 countries according to DelveInsight. The American Cancer Society estimates that in the U.S., liver cancer incidence has tripled since 1980, with an estimated 41,000 cases diagnosed and 31,000 deaths annually. Incidence of liver cancer is much higher in other countries, with more than 800,000 diagnoses and 700,000 deaths estimated globally each year.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for advanced hepatocellular carcinoma in a pivotal Phase III trial. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are "forward looking statements". Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to the COVID-19 pandemic and the Russian invasion of Ukraine; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the "Risk Factors" section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 24, 2022 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220823005373/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Late breaking news. Positive PR today. Moving in the right direction. Could it possible that sub-analysis revealed other posible indications, venereology related?
Nonetheless, very good news today.
IMO
A very perplexing company indeed.
https://finance.yahoo.com/news/fite-selected-present-positive-psoriasis-110000461.html
What do you make of todays PR?
Can-Fite Selected to Present the Positive Psoriasis Phase III Data at the 31st European Academy of Dermatology and Venerology Congress
https://finance.yahoo.com/news/fite-selected-present-positive-psoriasis-110000461.html
Presentation by study’s co-author Dr. Kim Papp, a Key Opinion Leader who has completed over 150 studies and worked on numerous drugs now on the market
Dr. Papp is designing Can-Fite’s pivotal Phase III psoriasis registration trial
PETACH TIKVA, Israel, August 22, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today that Dr. Kim A. Papp, MD, PhD, will present late-breaking news at the 31st European Academy of Dermatology and Venerology (EADV) Congress from an ongoing analysis of Can-Fite’s recently completed Phase III COMFORT™ study in which Piclidenoson met its primary endpoint with statistically significant improvement over placebo in psoriasis patients. The presentation titled "Treatment of plaque psoriasis with piclidenoson: Efficacy and safety results from a phase 3 clinical trial (COMFORT)" will be delivered on September 10, 2022, during the Late Breaking News session from 8:30 am to 11:45 am in Milan, Italy.
The study is co-authored by numerous dermatology key opinion leaders, researchers, and investigators, in Europe, Israel, and Canada, including Dr. Papp who is leading the design of Can-Fite’s pivotal Phase III psoriasis registration trial, which will be submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for market clearance of Piclidenoson in the treatment of moderate to severe psoriasis.
Based in Waterloo, Ontario, Canada, Dr. Papp has over 25 years’ experience as a Principal Investigator. Internationally renowned as a Key Opinion Leader in clinical research, Dr. Papp has conducted over 70 international dermatology studies on a wide range of dermatological disorders. The K. Papp Clinical Research center is considered one of the top clinical research centers in the world. Instrumental in improving and refining study designs, Dr. Papp has completed over 150 research studies on 50 compounds and has worked on new treatments that are now available and helping tens to hundreds of thousands of patients with their condition.
"As we continue to analyze the data from our COMFORT study, we are gaining additional insight into Piclidenoson’s efficacy and safety. Upon completing the latest sub-analysis, we look forward to Dr. Papp presenting new data at EADV," stated Can-Fite CEO Dr. Fishman. "As we work closely with Dr. Papp on finalizing the pivotal Phase III study protocol, we are grateful to the talented group of researchers who helped conduct COMFORT and analyze the data for this study."
About Piclidenoson
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II clinical studies. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.
About the Phase III COMFORT™ Study
The COMFORTTM CF101-301PS, is a Phase III randomized, double-blind, placebo- and active-controlled study of the efficacy and safety of daily Piclidenoson (CF101) administered orally in patients with moderate-to-severe plaque psoriasis. The primary objectives of this study are to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg twice daily (BID) in patients with moderate-to-severe plaque psoriasis, compared with placebo, as determined by the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) at Week 16 (superiority); and evaluate the safety of oral Piclidenoson in this patient population. The secondary objectives of this study are to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg BID, compared with placebo, as determined by the proportion of subjects who achieve, respectively, PASI 50, Physician Global Assessment (PGA) score of 0 or 1, and improvement on the Psoriasis Disability Index (PDI) at Week 16 (superiority); evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg BID, compared with Otezla (apremilast), as determined by the proportion of subjects who achieve PASI 75, PGA score of 0 or 1, PASI 50, and improvement in PDI at Weeks 16 and 32 (non-inferiority); and evaluate the efficacy and safety data for Piclidenoson through the extension period of up to 48 weeks of treatment.
Can-Fite: Reports Progress in the Development of Piclidenoson for Osteoarthritis in Pets Through its Partner Vetbiolix
https://finance.yahoo.com/news/fite-reports-progress-development-piclidenoson-112500193.html
Safety study successfully completed; efficacy trial to commence and financially covered by Vetbiolix
Canine osteoarthritis market is projected to reach $3 billion by 2028
PETACH TIKVA, Israel, August 17, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today that through a development and commercialization agreement signed with Vetbiolix in June of 2021, Piclidenoson is set to enter a clinical trial for the treatment of osteoarthritis in dogs. The canine osteoarthritis market is projected to reach $3 billion by 2028.
Vetbiolix, a France-based veterinary biotech company, which has the exclusive right to Piclidenoson in the veterinary osteoarthritis market for companion animals including cats and dogs for two years, recently completed an initial study in dogs to explore dose-range safety and pharmacokinetics. Piclidenoson was well tolerated, with the pharmacokinetic data proportional to dose. Based on these data, Vetbiolix is moving forward with clinical safety and efficacy studies in dogs with osteoarthritis.
If the study yields positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval.
Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs) which only treat symptoms and carry significant harmful side effects and an injectable disease-modifying osteoarthritis drug (DMOAD) that targets the progression of the disease.
"We have had a highly productive collaboration with Vetbiolix and are very pleased that they are moving Piclidenoson forward into clinical efficacy studies in dogs with osteoarthritis," stated Can-Fite CEO Dr. Fishman. "We are hopeful that Piclidenoson, with its excellent safety and efficacy profile in human auto-immune disease, will also provide an effective treatment for canines with osteoarthritis resulting in greater quality of life for dogs and their human families."
About Piclidenoson
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II clinical studies. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.
A very nice surprise indeed.
Sure am glad to have
been wrong.
Hopefully they’ll have a late reaction to the news, ‘cause the PR is good. It could put approval 2 years out though.
IMO
Not a too enthusiastic market reaction,
and this is an understatement.
CANF earned this attitude rightfully!
Let’s see how the market reacts.
The news couldnt even break past a $1.00. Very concerning.IMO
Can-Fite to Submit FDA & EMA Registration Plans for Piclidenoson in the Oral Treatment of Moderate to Severe Psoriasis
https://finance.yahoo.com/news/fite-submit-fda-ema-registration-110000722.html
Further analysis of Phase III COMFORT™ data show Piclidenoson’s superior safety profile and higher patient compliance compared to Otezla®
PETACH TIKVA, Israel, July 11, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today that it is planning to submit its registration plans to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for its lead drug candidate Piclidenoson in the treatment of moderate to severe psoriasis.
Can-Fite recently reported topline results from its Phase III COMFORT™ study which met its primary endpoint with statistically significant improvement over placebo in psoriasis patients and an excellent safety profile for Piclidenoson. Further analysis of the Phase III COMFORT™ data point towards a better safety profile for Piclidenoson as compared to Otezla, which induced gastro-intestinal adverse events in 6% of patients compared with 1% in patients treated with placebo or Piclidenoson. Discontinuation of treatment amongst patients treated with Otezla was significantly higher compared to that of the Piclidenoson treated patients.
A sub-analysis of the efficacy data that divided patients into those who had PASI>25 (more severe psoriasis) and PASI<25 (less severe) at baseline revealed that patients who started with higher PASI values at entry benefitted more from treatment with Piclidenoson as compared to placebo. This result demonstrates the efficacy of Piclidenoson in the treatment of patients with more severe disease.
In its registration plans, Can-Fite will submit the final efficacy and safety results from COMFORT™, a multicenter, randomized, placebo- and active-controlled, double-blind study that assessed the efficacy and safety of Piclidenoson in more than 400 adults with moderate to severe plaque psoriasis together with a request for registration advice to the FDA and EMA. Additionally, current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data will be submitted to the agencies along with a pivotal Phase III protocol and other supporting clinical pharmacology plans.
"The additional safety and efficacy data that emerged following our topline Phase III results point to a strong market positioning for Piclidenoson among approved oral psoriasis drugs. Today, a large percentage of people living with psoriasis choose not to be treated with biologics due to reported serious side effects and the need to be treated in a clinic. Similarly, a percentage of patients using Otezla, the leading oral drug for psoriasis, suffer from gastrointestinal issues and discontinue treatment. We believe that if Piclidenoson achieves its primary endpoint once again in an upcoming pivotal Phase III study, Piclidenoson will offer a safe and effective long-term treatment for people living with psoriasis, including those with the most severe cases," stated Can-Fite Medical Director, Dr. Michael Silverman.
About Piclidenoson
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II clinical studies. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.
About the Phase III COMFORT™ Study
The COMFORT™ CF101-301PS, is a Phase III randomized, double-blind, placebo- and active-controlled study of the efficacy and safety of daily Piclidenoson (CF101) administered orally in patients with moderate-to-severe plaque psoriasis. The primary objectives of this study are to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg twice daily (BID) in patients with moderate-to-severe plaque psoriasis, compared with placebo, as determined by the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) at Week 16 (superiority); and evaluate the safety of oral Piclidenoson in this patient population. The secondary objectives of this study are to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg BID, compared with placebo, as determined by the proportion of subjects who achieve, respectively, PASI 50, Physician Global Assessment (PGA) score of 0 or 1, and improvement on the Psoriasis Disability Index (PDI) at Week 16 (superiority); evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg BID, compared with Otezla (apremilast), as determined by the proportion of subjects who achieve PASI 75, PGA score of 0 or 1, PASI 50, and improvement in PDI at Weeks 16 and 32 (non-inferiority); and evaluate the efficacy and safety data for Piclidenoson through the extension period of up to 48 weeks of treatment.
Im done with them as soon as I can get close to break even Im OUT.
No email reply , no tel reply, not even
a possibility to leave a message.
Very disappointing!
No reaction from CANF ir, i will
call the company later the day.
Any result will be published here.
This company can never hold a gain. Ive been sitting on this now for two years and cant break even.
Damage done already. A correction should be forthcoming. I’m positive BW will not claim responsibility for the gaffe.
IMO
They used Business Wire (a Berkshire Hathaway company and the global leader in press release distribution) to write and publish the PR.
I do suspect whoever at Business Wire who wrote this will be in hot water right about now.
I suppose we are all in agreement. A correction PR is a must.
IMO
Indeed. With a large CORRECTION written at the beginning
Of course, but of course we would prefer
a public official PR amendment!
Me2. if I get a reply, I’ll post.
I guess they blew the PR then.
Nope, not any biased press, was copy/paste from the Canfite PR:
https://ir.canfite.com/news-events/press-releases/detail/993/can-fite-announces-positive-top-line-results-from
I rushed an email to IR with exactly your
query. Hopefully they will check and advz,
myself i was perplexed as well!
Correct, primary endpoints met. Pivotal too. Maybe a slight error in part of the non-biased press? I don’t think so.
IMO
Confused here. I think they wrote something incorrectly in that quote?
This was already a global pivotal trial agreed with the EMA at least.
Press Release from November 1st, 2016
CAN-FITE ADVANCES TOWARDS A PIVOTAL PHASE III CLINICAL TRIAL IN PSORIASIS WITH PICLIDENOSON (CF101) FOLLOWING REACHING AGREEMENT WITH EMA
"today announced that it has reached an agreement with the European Medicines Agency (EMA) on the final design of a global pivotal Phase III trial for its lead drug candidate, Piclidenoson (CF101), in the treatment of psoriasis."
"Phase III trial is a randomized, double-blind, placebo- and active-controlled study that will investigate the efficacy and safety of daily Piclidenoson administered orally as compared to placebo as its primary endpoint and as compared to apremilast (Otezla®) as its secondary endpoint in approximately 400 patients with moderate-to-severe plaque psoriasis. Medication is to be taken orally twice daily for 32 weeks in a double-blinded fashion. The primary end point will be the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) vs. placebo at week 16. The secondary endpoints will include non-inferiority to Otezla® on week 32 and efficacy and safety data for CF101 through the extension period of up to 48 weeks of treatment. Patients will be selected to the study based on over expression of the A3AR biomarker."
Clearly the same trial.
https://ir.canfite.com/news-events/press-releases/detail/771/can-fite-advances-towards-a-pivotal-phase-iii-clinical
also from a Can-Fite short introductory paper made by the company itself in December 2021.
Piclidenoson Clinical Development
• Phase III in Psoriasis – Topline Results Expected Q1 2022
Can-Fite completed enrollment of ~400 patients with moderate-to-severe psoriasis in its
pivotal Phase III Comfort™ trial based on positive results from an interim analysis of the
data. The trial is designed to establish superiority vs. placebo and non-inferiority vs.
Otezla®, an oral drug that generated $1.9 B in 2020 sales, projected to be $3.4 B by 2026
https://docs.publicnow.com/viewDoc?hash_primary=3150C2317F29DE465022FAA827AD9B8BCCCA630B
Maybe they just messed up in a rush to write the PR, or meant to write that they will approach the EMA with the data, and the FDA with a protocol for a pivotal phase III study? I mean they met the primary end-point with statistical significance. No need to redo a clinical trial when you meet the Primary Endpoint with Statistical Significance.
The global psoriasis treatment market is projected to grow from $26.37 billion in 2022 to $47.24 billion by 2029, exhibiting a CAGR of 8.7% in forecast period... Read More at:- https://www.fortunebusinessinsights.com/industry-reports/psoriasis-treatment-market-100600
Even a 10% market penetration would lift this company into prominence and with it the share price.
IMO
I hope so. The market is in a downturn cycle, IMO. Maybe the news will bring a lot of investors looking to park their investment on a highly potential stock like CanFite.
It’s been under the radar due to the company name.
IMO
Correction, “piclidenoson”
I wonder what the brand name might be!
IMO
On the other hand CANF s/p is so
depressing low, hence it should be
considered good news and fetch
some + 25% by EOD.
Having said that, the bio market is
real crazy and not stable nowadays.
Just throwing it out there,, superiority to Otezla outcome was a secondary outcome measure. Not needed for approval. It would been nice had it been superior in 32 weeks, but people live much longer than that. I suspect once approved, provided it does get approved, patient’s and physicians choice will dominate.
Otezla side effects are huge compared to piclidenodon.
IMO
You are right. Let’s see how the big boys try to protect their market.
“A linear increase in the response of patients to Piclidenoson was achieved along the study period, on week 48 reaching PASI 50 in 90% of patients, PASI 90 in 10% of patients and PDI improvement in 60% of patients.”
Linear increase. It may not have been superior to otezla, however, i read this as it works just as good but it will take longer than 32 weeks, and without the nasty side effects of Otezla.
IMO
Can-Fite stock rises 23% as psoriasis drug beats placebo but lags behind Otezla in phase 3 trial
Jun. 29, 2022 8:40 AM ETCan-Fite BioPharma Ltd. (CANF)AMGN
By: Ravikash, SA News Editor
Can-Fite BioPharma's (NYSE:CANF) oral drug piclidenoson helped reduce severity of symptoms compared to placebo, but failed to beat Amgen's (AMGN) Otezla in adult patients with moderate to severe plaque psoriasis in a phase 3 trial.
Plaque psoriasis causes dry, itchy, raised patches (plaques) on the skin.
The study, dubbed COMFORT, included more than 400 adults and evaluated piclidenoson 2-mg or 3-mg twice daily, against placebo.
The company said piclidenoson 2-mg or 3-mg, had clinically equivalent efficacy responses and at week 16, patients receiving the 3-mg dose showed statistically significant improvement in severity of disease compared to placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response (Piclidenoson 3mg: 9.7% vs. placebo: 2.6%). PASI 75 indicates a 75% or greater reduction in PASI scores from the time treatment started.
However, when compared to Amgen's (AMGN) Otezla, piclidenoson showed inferiority with respect to change in severity, or PASI, at week 32, which was the secondary goal to beat. PASI 75 (17% for piclidenoson vs. 26.2% for Otezla).
"Based on Piclidenoson’s safety and efficacy data revealed in this trial, we plan to approach the U.S. FDA and the European EMA with a protocol for a pivotal Phase III study for drug approval and registration,” stated Can-Fite CEO Pnina Fishman.
The company noted that piclidenoson was superior to Otezla in the Psoriasis Disability Index (PDI), a questionnaire measuring health-related quality of life, (20.5% for piclidenoson versus 10.3% for Otezla).
Can-Fite noted that piclidenoson had an excellent safety profile overlapping that of placebo and was better when compared to Otezla.
------------------------------------------------------------------------------
Let's see how the market reacts to these data.
“superiority of Piclidenoson as compared to Otezla in the Psoriasis Disability Index (PDI) (20.5% vs. 10.3%, respectively, P<0.05).”
I like it. I like it a lot.
IMO
"Based on Piclidenoson’s safety and efficacy data revealed in this trial, we plan to approach the U.S. FDA and the European EMA with a protocol for a pivotal Phase III study for drug approval and registration," stated Can-Fite CEO, Dr. Pnina Fishman.
Can-Fite Announces Positive Top-Line Results from Piclidenoson Phase III COMFORT™ Study in Moderate to Severe Psoriasis
https://finance.yahoo.com/news/fite-announces-positive-top-line-110000545.html
Phase III COMFORT™ study met its primary endpoint with statistically significant improvement and Piclidenoson had an excellent safety profile
Can-Fite has licensing deals for the marketing of Piclidenoson for the treatment of Psoriasis in multiple global regions
PETACH TIKVA, Israel, June 29, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced positive top-line results from the COMFORT™ trial, a Phase III, multicenter, randomized, placebo- and active-controlled, double-blind study to assess the efficacy and safety of Piclidenoson in more than 400 adults with moderate to severe plaque psoriasis.
The study data show that patients treated with oral Piclidenoson 2 mg or 3 mg twice daily, had clinically equivalent efficacy responses. At week 16, patients receiving Piclidenoson 3mg demonstrated statistically significant improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response: Piclidenoson 3mg: 9.7% vs. placebo: 2.6% (P< 0.04). Secondary endpoint parameters at week 32 comparing Piclidenoson to the active control drug, Otezla, revealed inferiority with respect to PASI 75 (17% vs. 26.2%, respectively) and PASI 50 (34.1% vs. 49.5%, respectively), but revealed superiority of Piclidenoson as compared to Otezla in the Psoriasis Disability Index (PDI) (20.5% vs. 10.3%, respectively, P<0.05). A linear increase in the response of patients to Piclidenoson was achieved along the study period, on week 48 reaching PASI 50 in 90% of patients, PASI 90 in 10% of patients and PDI improvement in 60% of patients.
Piclidenoson had an excellent safety profile overlapping that of the placebo treated patients, showing a better safety profile when compared to Otezla.
"Based on Piclidenoson’s safety and efficacy data revealed in this trial, we plan to approach the U.S. FDA and the European EMA with a protocol for a pivotal Phase III study for drug approval and registration," stated Can-Fite CEO, Dr. Pnina Fishman.
Dr. Michael T Goldfarb, MD, dermatologist and attending physician, Beaumont Hospital, Dearborn, Michigan, who has performed numerous psoriasis clinical trials over the last 38 years, commented, "Psoriasis causes skin inflammation, which impacts quality of life for patients. Our aim is to support more patients in achieving control of their symptoms, and especially using drugs with a good safety profile in this chronic disease which may require lifelong treatment. The clinically meaningful improvements seen in this trial, in both skin symptoms and quality of life, underline the highly favorable therapeutic index of Piclidenoson in psoriasis. Taken together, the results of the COMFORT™ trial strengthen our belief that oral Piclidenoson can address important unmet needs for patients with psoriasis, where the goal is an efficacious drug with an excellent safety profile to treat this chronic and devastating disease."
Full results from the COMFORT™ Phase III study will be presented at an upcoming medical conference and published in a peer-reviewed medical journal.
Can-Fite has five out-licensing deals for marketing and distribution of Piclidenoson for the treatment of psoriasis in markets including Canada, Eastern Europe, Central Europe (Austria, Swiss, Spain), China, and South Korea.
About Piclidenoson
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II clinical studies. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.
About the Phase III COMFORT™ Study
The COMFORT™ CF101-301PS, is a Phase III randomized, double-blind, placebo- and active-controlled study of the efficacy and safety of daily Piclidenoson (CF101) administered orally in patients with moderate-to-severe plaque psoriasis. The primary objectives of this study are to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg twice daily (BID) in patients with moderate-to-severe plaque psoriasis, compared with placebo, as determined by the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) at Week 16 (superiority); and evaluate the safety of oral Piclidenoson in this patient population. The secondary objectives of this study are to evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg BID, compared with placebo, as determined by the proportion of subjects who achieve, respectively, PASI 50, Physician Global Assessment (PGA) score of 0 or 1, and improvement on the Psoriasis Disability Index (PDI) at Week 16 (superiority); evaluate the efficacy of oral Piclidenoson 2 mg or 3 mg BID, compared with Otezla (apremilast), as determined by the proportion of subjects who achieve PASI 75, PGA score of 0 or 1, PASI 50, and improvement in PDI at Weeks 16 and 32 (non-inferiority); and evaluate the efficacy and safety data for Piclidenoson through the extension period of up to 48 weeks of treatment.
Any news at all doesnt seem to go far with this ticker.
that will be important
Been in this a long time. Any news at all doesnt seem to go far with this ticker.
that will be important
Phase III Psoriasis Study Data Expected Q2 2022 – Topline results are expected in Q2 2022 in Can-Fite’s Phase III Comfort™ psoriasis study for both its 16 week primary endpoint and 32 week secondary endpoint. The study is designed to establish Piclidenoson’s superiority compared to placebo at 16 weeks and non-inferiority compared to Apremilast (Otezla®) at 32 weeks. During the first quarter, a preclinical study showed Piclidenoson destroyed pathological skin cells, offering further evidence of potential efficacy in psoriasis.
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