RCE Share Price History
05 Aug, 2020
Recce Pharmaceuticals Announces Positive Oral Data on New RECCE® 435 Against Helicobacter Pylori in Animal Model
RECCE 435 Oral Rat Study % Positive for H. pylori, Urease Test Mean Body Weights of Rats Following Oral Administration w/vehicle and RECCE 435 Group Mean Body Weights of Rats Following Oral Administration w/vehicle and RECCE 435 GroupHighlights: * New RECCE® 435 oral showed dose-dependent and efficacy against Helicobacter pylori (H. pylori) bacteria isolated from a patient with a duodenal ulcer compared to control vehicle in independent study model in rats * Separate and independent repeat oral dosing study indicates 500mg/kg twice daily vs. water control yielded no observed toxicity with favorable weight gain throughout * High solubility and antibacterial effect supportive of a ‘targeted’ oral therapy for stomach infection * Discussions with world leading H. pylori experts to assess commercial pathway SYDNEY, Australia, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the Company developing a new class of synthetic anti-infectives, today announced positive efficacy activity against Helicobacter pylori (H. pylori) bacteria in rats treated with new antibiotic RECCE® 435, including a favorable toxicity profile in a related study. RECCE® 435 is a broad-spectrum synthetic polymer antibiotic formulated for oral use.“The Company is most encouraged by these data, further indicating a long anticipated potential against H. pylori, a significant pathogen with a particular prevalence in the neighboring Asia-Pacific region,” said Dr. John Prendergast, Recce Pharmaceuticals Non-Executive Chairman. “This study further endorses our ever promising therapeutic potential to advance a new class of synthetic antibiotics and anti-infectives for the treatment of a wide spectrum of pathogens capable of causing deadly infections. While Recce is pleased with these results, they do not mean that the RECCE® 435 compound will be safe or effective for use in humans.”The efficacy study was conducted by an independent Contract Research Organization to assess oral dose-dependent efficacy of RECCE® 435 in-vivo (rats) against a clinical isolate of H. pylori. H. pylori is a species of Gram-negative bacteria commonly infecting the lining of the stomach and upper digestive tract. There is no available first-line therapy that is curative in all patients at this time and it is a major cause of morbidity and mortality worldwide; it is estimated more than 50% of the global population is infected.1,2In the study, five groups of 10 rats each were observed. Three of these groups were treated with varying doses of RECCE® 435 (250, 500, 1,000 mg/kg) and dose-dependent efficacy was seen at all doses with significant reduction in bacterial load. Upon completion of the study, a urease test was carried out upon the stomach lining to confirm the presence of H. pylori in the subjects. Helicobacter pylori can survive within the acidic environment of the stomach by producing an enzyme called urease. Therefore, H. pylori presence was measured by a urease diagnostic test in the stomachs of rats in the study with those. No signs of toxicity were observed at any dosage level throughout the efficacy study.A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2e899f19-b3ca-4432-a304-9000d38b5c13GroupGroup IDRatsUrease test% Positive for H. pylori [Urease Test] PositiveNegative 1Uninfected control100100 2Infected control109190 3AB Combo 135 mg/kg (Amoxicillin 90 mg/kg + Clarithromycin 45 mg/kg)105550 4Infected + RECCE® 435 - 250 mg/kg106460 5Infected + RECCE® 435 - 500 mg/kg104640 6Infected + RECCE® 435 - 1000 mg/kg102820 RECCE® 435 mg/kg dosing is based upon ‘total administered solution’. A significant proportion of RECCE® 435 administered solution quoted includes inactive components such as diluent/water and stabilizing medium. The Active Pharmaceutical Ingredient (API) as is sometimes the quoted mg/kg of the comparative product/s, likely to dramatically benefit by way of reduction to the otherwise stated RECCE® figure.This study assessed a combination of two broad spectrum antibiotics being used – Amoxicillin and Clarithromycin. Amoxicillin was used at a higher dosage, being one of the most active antimicrobials against H. pylori.3 This standard therapy has recently been undermined by its ineffectiveness for a number of reasons including the development of high resistance rates and the lack of novel drugs.An additional independent study examining the safety of oral dosing of RECCE® 435 up to 500mg/kg was administered to groups of five mice each twice daily for seven days, compared to water-only administration. The data indicates their feeding habits, which contributes to weight gain, were not negatively impacted, supporting overall general and gastrointestinal health.A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c1a9300a-c2e6-42a9-98ed-3c7e276d7300Mean body weights of rats following oral administration with vehicle and RECCE® 435 group Body weight (g) (Mean ± SD) DaysDay 1Day 2Day 3Day 4Day 5Day 6Day 7 Vehicle Water – dosed twice daily (each 12h) over 7 days 213 ± 8.09224.4 ± 6.73236.2 ± 4.82246 ± 5.15253.2 ± 4.15262.6 ± 3.65268.2 ± 5.81 RECCE® 435 - 500 mg/kg dosed twice daily (each 12h) over 7 days 213.4 ± 4.56223.4 ± 9.32231.6 ± 7.7240 ± 4.74246.8 ± 5.89255.2 ± 9.65269.4 ± 5.77 H. pylori was recently added by the FDA to the Agency's list of qualifying pathogens that have the potential to pose a serious threat to public health. As a result, drug treatments being studied for patients with H. pylori infection have been granted Qualified Infectious Disease Product (QIDP) designation. In addition to H. pylori increasing risk of ulcers and other gastric diseases, research suggests that some 35-60% of gastric adenocarcinomas are attributable to H. pylori infection.4The World Health Organisation (WHO) also lists H. pylori as a priority pathogen on its list of antibiotic-resistant bacteria that pose the greatest threat to human health.5 Helicobacter pylori is known to cause stomach inflammation (gastritis) and more serious conditions such as stomach ulcers and stomach cancer.6About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialization of new classes of synthetic anti-infectives designed to address the urgent global health problems of antibiotic resistant superbugs and emerging viral pathogens.Recce antibiotics are unique – their potency does not diminish even with repeated use, a common failure associated with existing antibiotics and their propensity to rapidly succumb to resistant superbugs.Patented lead candidate RECCE® 327, wholly owned and manufactured in Australia, has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms.The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval.Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of RECCE® technologies targeting synergistic, unmet medical needs.1 https://www.mja.com.au/journal/2016/204/10/epidemiology-clinical-impacts-and-current-clinical-management-helicobacter 2 https://www.racgp.org.au/afp/2014/may/helicobacter-pylori-eradication/ 3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5314729/ 4 https://journals.lww.com/ctg/Abstract/2013/03000/Helicobacter_Pylori_Test_and_Treat__Strategy_for.2.aspx 5 WHO list of bacteria 6 ttps://www.healthdirect.gov.au/helicobacter-pyloriExecutive DirectorMedia & Investor Relations (AU) Media & Investor Relations (USA) James GrahamAndrew GeddesMeredith Sosulski, PhD Reece Pharmaceuticals, Ltd.CityPRLifeSci Communications +61 (02) 8075 4585+61 (02) 9267 4511+1 929 469 3851 firstname.lastname@example.org@email@example.com
22 Jul, 2020
If you want to know who really controls Recce Pharmaceuticals Ltd (ASX:RCE), then you'll have to look at the makeup of...
16 Jul, 2020
Recce Pharmaceuticals Enters Agreement with Path BioAnalytics to Test RECCE® Compounds in Expanded SARS-CoV-2 Program
Highlights: International study will be conducted in a laboratory at a leading academic institution in the U.S. to evaluate anti-viral activity of RECCE® 327 and new.
14 Jul, 2020
SYDNEY, Australia, July 14, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the Company developing new classes of synthetic anti-infectives, today announced the appointment of Alan W. Dunton, M.D., to its Board of Directors as an independent Non-Executive Director and as a member of the Company’s Audit & Risk and Remuneration & Nomination Committees. “On behalf of all the team at Recce, we welcome Dr. Dunton to our Board of Directors,” stated Dr. John Prendergast, Recce Pharmaceuticals Non-Executive Chairman. “Alan joins us at a critical time as we move into the second half of 2020, where we anticipate a number of human clinical trials evaluating our broad-spectrum novel antibiotic, RECCE® 327\. In addition, we will continue to investigate the efficacy of our synthetic compounds against SARS-CoV-2 among other key clinical development milestones. Alan’s biopharmaceutical industry experience with large pharma R&D organizations and public biotechnology companies, particularly commercialization of three antibiotics, two of which are now considered to be ‘blockbuster’ drugs, will be invaluable to Recce. We look forward to his guidance and counsel.”Dr. Dunton brings more than three decades of senior pharmaceutical experience leading clinical research development efforts, advancing drug candidates including a number of blockbuster antibiotics, through regulatory review and commercialization at fortune 500 companies including Johnson & Johnson and Roche.Dr. Dunton said, "I am pleased to join Recce's Board at such a pivotal time in the Company’s development, as its new classes of synthetic anti-infectives continue to show significant promise in tackling the global health problems of antibiotic resistant superbugs and emerging viral pathogens. I look forward to supporting the Company in advancing its pipeline candidates through the clinic."Dr. Dunton has held leadership positions at various biotechnology and pharmaceutical companies including serving as president and chief executive officer at Panacos Pharmaceuticals, Inc., Metaphore Pharmaceuticals, Inc., and chief operating officer at Emisphere Technologies, Inc. Dr. Dunton served in several positions at Johnson & Johnson including president and managing director at the Janssen Research Foundation, where he was responsible for leading over 2,000 professionals worldwide, and prior to this as vice president of global clinical research and development at the R.W. Johnson Pharmaceutical Research Institute. Dr. Dunton earned his medical degree from New York University School of Medicine following his bachelor’s degree in biochemistry from the State University of New York at Buffalo. Dr. Dunton then completed his fellowship in clinical pharmacology at New York Hospital/Cornell University Medical Center and, in 1987, was awarded The Nellie Westerman Prize from the American Federation for Clinical Research (AFCR) for his work in medical ethics. He currently serves on the boards of Oragenics, Inc., Palatin Technologies, Inc., Cormedix, Inc., and Regeneus, Ltd., an Australian clinical-stage company in the field of regenerative medicine.About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialization of new classes of synthetic anti-infectives designed to address the urgent global health problems of antibiotic resistant superbugs and emerging viral pathogens.Recce antibiotics are unique – their potency does not diminish even with repeated use, a common failure associated with existing antibiotics and their propensity to rapidly succumb to resistant superbugs.Patented lead candidate RECCE® 327, wholly owned and manufactured in Australia, has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms.The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval.Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of RECCE® technologies targeting synergistic, unmet medical needs. Executive DirectorMedia & Investor Relations (AU)Media & Investor Relations (USA) James GrahamAndrew GeddesMeredith Sosulski, PhD Reece Pharmaceuticals, Ltd.CityPRLifeSci Communications +61 (02) 8075 4585+61 (02) 9267 4511+1 929 469 3851 firstname.lastname@example.org@email@example.com
08 Jul, 2020
Recce Pharmaceuticals Announces RECCE® Compounds Selected by CSIRO/Doherty Institute in Priority 1 Candidate Group for SARS-CoV-2 Antiviral Screening Program
Highlights: RECCE® 327 and New RECCE® 529 compounds were selected for their unique mechanisms of action against hyper-mutation, as indicated on bacteria and viruses.
06 Jul, 2020
SYDNEY, Australia, July 06, 2020 -- Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the Company developing new classes of broad-spectrum synthetic antibiotics, today announced.
04 May, 2020
Recce Pharmaceuticals Announces Positive Data on RECCE® 327 Against Neisseria gonorrhoeae in STD Animal Model
Highlights: Statistically significant reduction of Neisseria gonorrhoeae bacteria in reproductive organs of female miceRECCE® 327 outperformed market approved drug Meropenem.
30 Apr, 2020
Recce Pharmaceuticals Announces First-Quarter 2020 Financial Results and Provides Operational Highlights
Highlights: Strong cash position with reserves of AUD $4.09MFormalized a Phase I Clinical trial agreement to conduct a first-in-human study of RECCE® 327Completed.
23 Apr, 2020
Recce Pharmaceuticals Announces More Positive Data on RECCE® 327 Against MRSA Superbug in Burn Wound Animal Model
Highlights: Statistically significant reduction in MRSA superbug bacterial load and higher percentage of wound contraction with RECCE® 327 as compared to Soframycin in rat.
20 Apr, 2020
Recce Pharmaceuticals Announces Positive Data on RECCE® 327 Against Influenza A Respiratory Virus Infection in Animal Model
Highlights: Dramatic reduction in viral load in the lungs of mice treated with RECCE® 327 as compared to the approved antiviral drug treated and vehicle control untreated.
15 Apr, 2020
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08 Apr, 2020
Recce Signs Phase I Clinical Trial Agreement to Initiate Study of Synthetic Antibiotic RECCE® 327 in Healthy Subjects
Recce Pharmaceuticals Ltd (RCE.AX), the company developing a new class of broad-spectrum synthetic antibiotics, today announced it has formalized a Phase I clinical trial agreement to conduct a first-in-human study of its lead compound RECCE® 327 in 40 healthy subjects. The Phase I clinical study of RECCE® 327 will be conducted at a specialized clinical trial facility in Sydney, Australia, independent of the hospital system.
16 Jan, 2020
If You Had Bought Recce Pharmaceuticals (ASX:RCE) Stock A Year Ago, You Could Pocket A 123% Gain Today
The Recce Pharmaceuticals Ltd (ASX:RCE) share price has had a bad week, falling 11%. On the other hand, over the last...