Biodexa Pharmaceuticals PLC (BDRX) News

Will this ever go back up!!!

Men I wish I woke up early! Still stuck in this pos

Biodexa Announces Health Canada Has Approved Phase 2a Dose Confirmation Study Of Tolimidone In Type 1 Diabetes
Benzinga 2024-07-16T08:31:00-04:00

$1 close after 63M volume on 10m float

NOTHING NEFARIOUS GOING ON HERE

BDRX: Bummer.

We sure did but at least we are not 100% this one looks like it has made this move multiple times. So we should be good in the long term. No need to take a huge loss . Just average down when appropriate

BDRX: If you did NOT 'toss-the-farm' at this, well, YES ya might see what transpires in the Post-M here. It appears to be attempting somewhat of a (feeble) 'comeback' the last several minutes. Myself, I simply believe that the RECTUM-stuff this Firm deals with just did NOT resonate well with Wall Street. So, pun intended, WE got it up the ASS!!!!

Maybe after hours?

BDRX: I lost big here, Bro!!! (But during the past 2-weeks, any stock that had ANYTHING to do with CANCER, soared to Mars!!! But, of course, NOT this one!!!)

Same here .

is this a diluting POS?

BDRX: Hope so!!! (I'm an Atheist, but see me below right now, workin' ALL the angles --- and angels??)

PLANNING TO GET ALL BACK FROM "BDRX" EAGLE -EYE WATCHING, IF NEED BE I WILL ADD OWL-EYE----360 DEGREES

LCFY: And it's STILL soaring!!! 350% Up, non-stop!! $20 bucks coming there today!!)

LCFY: And it's STILL soaring!!! 350% Up, non-stop!! $20 bucks coming there today!!)

BDRX: Still holding all of it, unfortunately, at this depressing point. (And that @LCFY explosion!! Totally missed that beast!!!)

STAY AWAY DROM THIS GARBAGE...CHART IS A DISASTER

LOOKING FORWARD TO SCORE HUUUUUUUUUGE ON BDRX. WILL BOUNCE BACK, IF YOU STILL IN CONSIDER AVERAGE DOWN OR CAN BE BEARISH FOR NOW

TOO FAST FOR ME, SAW IT AT 93%, THOUGHT WILL NOSE-DIVE AFTER HALT BUT ***YOU CAN VISUALISE THE OUTCOME.

DID NOT SEE THE CHART , WANT TO BUY ON IMPULSE****THE CHART WAS EXTRAORDINARY, EVEN TILL NOW. STORNG HANDS

BDRX: Disaster, Capt. Tim!!! (Did you score on @LCFY??? I saw you screamin' about it, very early.)

WORST THAN LGVN, CAUTION BRO

BDRX: Monster TOILET-FLUSH, Bro. (Nasty!!! And not likely even a CHANCE of a comeback later today.)

PS: And all as @LCFY has just left our Solar System!!! (And, for NO FLUCKIN' reasons whatsoever!!!)

Yeah I was between the two! Picked the wrong one. Got trapped!!!!! Damnit

BDRX: Horrible Open --- @KZIA stole the show.

BDRX 1.19 bad open..... I take that back

Hault?

BDRX: Was a MONSTER-hard decision this morn,, T-F-C-D!!! To pick anything!!

BDRX looking good going into the open

better than vlcn kzia rnlx

BDRX: Grabbed some circa half-hour ago. (Hope Cancer-related stuff is still TRENDING!!)

BDRX..........................................https://stockcharts.com/h-sc/ui?s=BDRX&p=W&b=5&g=0&id=p86431144783

Biodexa Announces Additional Positive Results Of Phase 2 Trial Of eRapa in Treatment Of Precancerous Polyps in the GI Tract - Now 12-Month Data
CARDIFF, UK / ACCESSWIRE / July 11, 2024 / Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), an acquisition-focused clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is making good progress with eRapa™, its drug to treat Familial Adenomatous Polyposis (FAP).

FAP is a mostly inherited condition that puts people at a much greater risk of developing colorectal cancer. Positive 12-month data from a phase 2 clinical trial were recently presented at the 2024 InSIGHT biannual meeting in Barcelona.

With FAP, hundreds or thousands of precancerous polyps grow throughout the gastrointestinal tract. There is no approved therapeutic option for treating FAP patients - for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. People with FAP, which usually appears in the patient's mid-teens, end up eventually having their entire colon and/or rectum resected and having to carry a colostomy bag for the remainder of their lives . If left untreated, there is a 100% chance the person will develop colorectal cancer.

A Better Way Of Treating FAP

While multiple screenings and surgeries are a way of life for the more than 100,000 people worldwide who suffer from this condition, it doesn't have to remain that way.

Biodexa believes eRapa could be the first therapeutic option to treat this precancerous condition, and its data so far backs up that assessment. Results of a 12-month phase 2 clinical trial of eRapa demonstrated an overall 17% median decrease in overall polyp burden and an overall non-progression rate of 75%. Even more compelling, of patients in Cohort 2 (treated daily, alternate weeks), 89% of patients were deemed non-progressors at 12 months, with a median reduction in polyp burden of 29%. That could be gaming-changing for FAP patients if it means fewer surgeries with much improved quality of life. The 12-month data demonstrate a longevity of effect of eRapa.

"The promising phase 2 results, if confirmed in a registrational phase 3 study, may delay or potentially obviate the need for resection of the colon and/or rectum in FAP patients," said Stephen Stamp, CEO of Biodexa. "The six-month, and now 12-month, data together with its apparent tolerability suggest longer-term use of eRapa may be possible, with the potential to forestall resection and substantially increase the quality of life of patients with this devastating precancerous condition impacting up to 40,000 patients in the U.S. and up to 60,000 in Europe."

eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus, which slows down the mTOR (mammalian Target Of Rapamycin) protein. Too much mTOR has been linked to cancer.

Stopping It In Its Tracks

The phase 2 open-label study of 30 adults with FAP was conducted in seven U.S. centers of excellence. The median age of the trial participants was 43 years, with either an intact colon or one with a portion removed and at least ten noncancerous tumors in the rectal remnant. Patients were enrolled in three dosing cohorts, including every other day, daily every other week and daily. Although the primary endpoints were safety and tolerability of eRapa and percentage change from baseline in polyp burden at six months, patients continued to receive treatment and monitoring for 12 months, leading to the new data.

Biodexa said the dosing given to cohort 2 - daily every other week - will likely be the preferred dosage regime for its phase 3 trial, which the company is gearing up to launch soon. That study is planned to be a double-blind placebo-controlled design recruiting approximately 140 high-risk patients diagnosed with germline or phenotypic FAP.

Biodexa's phase 2 results were presented at InSIGHT by Carol Burke, M.D., a specialist gastroenterologist at the Cleveland Clinic and a leading authority in FAP. Burke is the Principal Investigator for both the phase 2 study and the upcoming phase 3 study. The phase 2 trial was partially supported by $3 million in grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT). CPRIT is providing a $17 million grant for the phase 3 trial.

FAP may be rare, but for the tens of thousands of people suffering from this precancerous condition, there's got to be a better treatment. Biodexa believes it has that with eRapa. The phase 2 trial results seem to lean that way, and with a phase 3 study about to kick off, there may be hope on the horizon for FAP patients.

Contact:
Stephen Stamp, CEO, CFO
ir@biodexapharma.com

Important notice, please read: The information and statistical data contained herein may contain forward-looking statements that reflect the company's intentions, expectations, assumptions, or beliefs concerning future events, including, but not limited to, expectations with respect to FDA and other regulatory bodies approval of new products, technology, and product development milestones, the ability of the company to leverage its product development and negotiate favorable collaborative agreements, the commencement of sales, the size of market opportunities with respect to the company's product candidates and sufficiency of the company's cash flow for future liquidity and capital resource needs and other risks identified in the Risk Factor Section of the company's Annual Report on Form 10-K and any subsequent reports filed with the SEC. We do not undertake to advise you as to any change in this information. The forward-looking statements are qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the company's research and development programs. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Biodexa Pharmaceuticals PLC to provide investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.

SOURCE: Biodexa Pharmaceuticals PLC



View the original press release on accesswire.com

© Copyright 2024 ACCESSWIRE. All Rights Reserved.

$1.50s + 110%

.86

.90 kurplunk

come back in 6 months

.95 and selling off

$BDRX The 12-month results from the Phase 2 clinical trial of eRapa in Familial Adenomatous Polyposis (FAP) were presented at the InSIGHT 2024 meeting in Barcelona. Here are the key findings:

Reduction in Polyp Burden: There was a significant reduction in the total number of polyps compared to the baseline measurements.
Non-Progression Rates: The treatment showed high rates of non-progression, meaning it effectively prevented the growth and development of new polyps.
Safety Profile: eRapa was generally well-tolerated, with only a few serious adverse events reported, which were manageable and did not outweigh the benefits.
These results are promising for the potential use of eRapa in managing FAP, offering hope for a condition that currently has limited treatment options.
.

BDRX 10Q expected Friday 6/28

BDRX...................................https://stockcharts.com/h-sc/ui?s=BDRX&p=W&b=5&g=0&id=p86431144783

Twelve month Phase 2 Clinical Trial Results of eRapa™ in Familial Adenomatous Polyposis (FAP) to be Presented at Prestigious Biennial InSIGHT 2024 Meeting in Barcelona

Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announces that 12 month data of a Phase 2 clinical trial of eRapa in Familial Adenomatous Polyposis (“FAP”) are to be presented at the prestigious biennial InSIGHT 2024 meeting in Barcelona, Spain on June 22, 2024. Carol Burke, MD, the Principal Investigator, will present the six and 12 month data (NCT04230499) in an oral presentation at the meeting. Dr Burke presented the six-month data at the Digestive Disease Weekly meeting in Washington D.C. on May 21, 2024.

eRapa in FAP
FAP is characterized as a proliferation of polyps in the GI tract, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US2 and one in 11,300 to 37,600 in Europe3. eRapa has received Orphan Designation in the US with plans to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.

Results of the Phase 2 study at six months
In the duodenum, 14/18 (78%) patients were non-progressors with 11/18 (61%) of these patients with PR. In the colorectum, 25/29 (86%) patients were non progressors including all with an intact colon; of these 15/29 (67%) patients demonstrated PR including 4 with an intact colon. Only two drug-related Grade 3 Serious Adverse Events occurred during the trial (with no Grade 4 or 5 reported), and 97% of patients remained on treatment at six months. In summary, eRapa appeared safe and well-tolerated with a significant 24% reduction in the total polyp burden at six months compared with baseline (p=0.04) and an overall 83% non-progression rate.

when

when

on sale

BDRX...................................https://stockcharts.com/h-sc/ui?s=BDRX&p=W&b=5&g=0&id=p86431144783

Looking good

Is that why we have No FAP November?

Z

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BDRX..................................................https://stockcharts.com/h-sc/ui?s=BDRX&p=W&b=5&g=0&id=p86431144783

BDRX: Heck, last time I saw an iHub board THIS quiet, was on the AAPL board when Steve Jobs croaked!!

SONG BREAK: