Phase I, Pilot Study in Healthy Volunteers, to Assess the Safety and Pharmacokinetics of PCO-02, Which Active Ingredient is BPC-157, a Penta-deca-peptide From Gastric Source.

Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157, a pentadecapeptide from gastric source.

开始日期2015-10-01

申办/合作机构

PHARMACOTHERAPIA D.O.O.

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100 项与 Bepecin 相关的专利（医药）

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186

项与 Bepecin 相关的文献（医药）

2024-10-01·INFLAMMOPHARMACOLOGY

New studies with stable gastric pentadecapeptide protecting gastrointestinal tract. significance of counteraction of vascular and multiorgan failure of occlusion/occlusion-like syndrome in cytoprotection/organoprotection

Review

作者: Zubcic, Slavica ; Krezic, Ivan ; Seiwerth, Sven ; Kalogjera, Luka ; Strbe, Sanja ; Oreskovic, Ivana ; Smoday, Ivan Maria ; Sever, Marko ; Staresinic, Mario ; Sikiric, Suncana ; Coric, Luka ; Skrtic, Anita ; Brcic, Klara ; Kavelj, Ivana ; Oroz, Katarina ; Skoro, Marija ; Sikiric, Predrag ; Vranes, Hrvoje ; Boban Blagaic, Alenka ; Vukovic, Vlasta ; Beketic Oreskovic, Lidija ; Blagaic, Vladimir

Since the early 1990s, when Robert's and Szabo's cytoprotection concept had already been more than one decade old, but still not implemented in therapy, we suggest the stable gastric pentadecapeptide BPC 157 as the most relevant mediator of the cytoprotection concept. Consequently, it can translate stomach and gastrointestinal mucosal maintenance, epithelium, and endothelium cell protection to the therapy of other tissue healing (organoprotection), easily applicable, as native and stable in human gastric juice for more than 24 h. These overwhelm current clinical evidence (i.e., ulcerative colitis, phase II, no side effects, and no lethal dose (LD1) in toxicology studies), as BPC 157 therapy effectively combined various tissue healing and lesions counteraction. BPC 157 cytoprotection relevance and vascular recovery, activation of collateral pathways, membrane stabilizer, eye therapy, wound healing capability, brain-gut and gut-brain functioning, tumor cachexia counteraction, muscle, tendon, ligament, and bone disturbances counteraction, and the heart disturbances, myocardial infarction, heart failure, pulmonary hypertension, arrhythmias, and thrombosis counteraction appeared in the recent reviews. Here, as concept resolution, we review the counteraction of advanced Virchow triad circumstances by activation of the collateral rescuing pathways, depending on injury, activated azygos vein direct blood flow delivery, to counteract occlusion/occlusion-like syndromes starting with the context of alcohol-stomach lesions. Counteraction of major vessel failure (congested inferior caval vein and superior mesenteric vein, collapsed azygos vein, collapsed abdominal aorta) includes counteraction of the brain (intracerebral and intraventricular hemorrhage), heart (congestion, severe arrhythmias), lung (hemorrhage), and congestion and lesions in the liver, kidney, and gastrointestinal tract, intracranial (superior sagittal sinus), portal and caval hypertension, aortal hypotension, and thrombosis, peripherally and centrally.

2024-10-01·ALTERNATIVE THERAPIES IN HEALTH AND MEDICINE

Effect of BPC-157 on Symptoms in Patients with Interstitial Cystitis: A Pilot Study.

Article

作者: Ayadi, Bahram ; Walker, Christopher ; Lee, Edwin

Context:

Moderate to severe interstitial cystitis (also known as bladder pain syndrome) is a disabling disease with no effective treatment. Although pentosan polysulfate is an approved treatment for interstitial cystitis, some patients on this medication experience treatment failure after one year, and its long-term use has been linked to pigmentary maculopathy. The peptide Body Protective Compound 157 (BPC-157) is a possible treatment for interstitial cystitis but is currently not approved by the US Food and Drug Administration.

Objective:

To assess the safety and efficacy of BPC-157 manufactured by a 503A compounding pharmacy as a treatment for interstitial cystitis.

Participants:

Twelve women between the ages of 39 and 76 years with a mean age of 58.3 years participated in this trial at a private clinic. Of these, 10 were White, one was Asian, and one was Latina. None of the 12 women had responded to pentosan polysulfate.

Methods:

The women underwent cystoscopy and were treated with injections of the peptide BPC-157 (total of 10 mg) around the area of inflammation of the bladder during a single procedure. Global Response Assessment questionnaire was given to all the subjects to assess the efficacy of BPC-157.

Results:

Complete resolution of symptoms after one treatment was reported in 10 of 12 patients, who rated their success at 100%. The remaining 2 of 12 patients rated their success at 80%, with most symptoms resolved but about 20% of their symptoms lingering. No one dropped out of the study, and no adverse events were reported. This therapy was successful because all 12 patients scored a 5/5 on the Global Response Assessment.

Conclusion:

This is the first report of intravesical BPC-157 (10 mg) injection to help patients with moderate to severe interstitial cystitis who did not respond to pentosan polysulfate treatment.

2024-09-01·ARTHROSCOPY-THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY

Injectable therapeutic peptides–an adjunct to regenerative medicine and sports performance?

Letter

作者: Dekker, Travis J ; DeFoor, Mikalyn T

High level athletes and bodybuilders are constantly seeking novel therapies to enhance recovery and expedite return from injury-injectable peptides are a new and trending therapy that may be the wave of the future of in the realm of regenerative medicine research in treating joint injuries and osteoarthritis. Very early in vivo research of the pharmacokinetics suggests the possibility of Body Protection Compound 157 (BPC-157) appears to be at the forefront of therapeutic peptides with early demonstration of these experimental peptides optimizing endurance training, metabolism, recovery and tissue repair. While uUnregulated, yetand readily available for purchase over the internet, there is scarce orthopaedic literature investigating the clinical use and outcomes of these therapeutic peptides in tendon, muscle and cartilage injury. However, this has not slowed the recent exponential growth of the multi-billion-dollar industry in development of therapeutic peptides. As orthopaedic surgeons and team physicians, we should stay up-to-date with the latest pharmacokinetic, safety, ethical, and legal profilesregulations regarding synthetic peptide supplementation for injury recovery and sports performance optimization from our elite athletes to our fitness fanatics as these patients will continue to seek the latest and greatest in treatment options and will be approaching us with questions on their results, risks and benefits..

项与 Bepecin 相关的新闻（医药）

2023-11-30

·FiercePharma

Fighting unauthorized GLP-1 knockoffs, Novo Nordisk files 2 new lawsuits against Florida companies

Novo Nordisk is taking action again against companies that are allegedly making adulterated versions of its popular GLP-1 Ozempic, Wegovy and Rybesus. Seven weeks after a federal judge dismissed (PDF) a Novo Nordisk’s lawsuit, which accused a Florida pharmacy of selling unauthorized knockoffs of its GLP-1 drugs Wegovy, Ozempic and Rybelsus, Novo has sued the same company. Brooksville Pharmaceuticals is the target of a refiled Novo lawsuit, this one claiming there are impurities in the company’s compounded versions of the popular diabetes and weight-loss treatments. Earlier this month, Florida judge William Jung gave Novo three weeks to renew its complaint against Brooksville. In addition, Novo is suing another Florida company, Wells Pharmacy. In both complaints, Novo says that the companies are selling adulterated versions of the treatments that contain BPC-157, a peptide that promotes gastrointestinal healing but has not been sanctioned for use in compounded products because of safety risks. In September, the FDA clarified its ban on BPC-157, saying it would “consider taking action against a compounder” for using it or other bulk drug substances in its classification. Novo also says that the compounded versions from Wells and Brooksville contain at least 19% less semaglutide—the active ingredient in Wegovy, Ozempic and Rybelsus—than promised on their labels. “Compounded products do not have the same safety, quality and effectiveness assurances as FDA-approved drugs, and adulterated and misbranded injectable compounded drugs may expose patients to significant health risks,” Jason Brett, Novo’s executive director of medical affairs, said in a release. The complaints continue a feud between Novo Nordisk and companies accused of selling unauthorized versions of GLP-1 drugs. In June, Novo filed lawsuits against five companies in four states, charging them with false advertising, trademark infringement and unlawful sales. A month later, Novo alleged that four more companies, including Brooksville, were doing the same. In September, Eli Lilly got into the act, filing lawsuits against eight companies in the U.S. who are accused of producing or selling compounded versions of the popular GLP-1/GIP drug Mounjaro. A month later, Lilly went after 11 online pharmacies, including several overseas, that are allegedly importing, selling or distributing unauthorized versions of Mounjaro. In May, in warning consumers about unauthorized versions of the weight loss drugs, the FDA explained that some pharmacies are permitted to make compounded versions of treatments that are having supply shortages. But in the rush to provide these highly demanded medications, some pharmacies are making versions with unauthorized ingredients. As demand has increased for the weight loss drugs, sales have skyrocketed. In the third quarter, Lilly (38%) and Novo (29%) posted the largest year-over-year revenue increases in the industry. During the period, Ozempic and Wegovy combined for $4.7 billion in sales, which accounted for 57% of Novo’s revenue. Meanwhile, Mounjaro’s sales reached $1.4 billion in the quarter.