{"id":993,"date":"2023-11-06T00:58:28","date_gmt":"2023-11-06T00:58:28","guid":{"rendered":"https:\/\/economicherald.net\/?p=993"},"modified":"2023-11-06T00:58:28","modified_gmt":"2023-11-06T00:58:28","slug":"asx-health-stocks-pyc-on-the-same-page-with-fda-cleos-cancer-test-peer-reviewed","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=993","title":{"rendered":"ASX Health Stocks: PYC on the same page with FDA, Cleo\u2019s cancer test peer-reviewed"},"content":{"rendered":"

PYC to take ADOA drug to human clinical trials
\nImugene provides update of its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial
\nCleo\u2019s CleoDX Triage Test was published in \u2018Cancer\u2019 journal<\/p>\n

\u00a0<\/p>\n

PYC to commence human trials in 2024 after FDA meeting<\/h2>\n

PYC Therapeutics (ASX:PYC)<\/a><\/strong> announced that it has aligned with the US Food and Drug Administration (FDA<\/strong>) on the proposed path for its investigational drug candidate for ADOA (Autosomal Dominant Optic Atrophy).<\/strong><\/p>\n

Following pre-IND meeting with the FDA, PYC now anticipates progressing its drug candidate to human trials in the first half of calendar year 2024.<\/p>\n

Successful progression into human studies will mark the second first-in-class drug program that PYC has advanced into the clinic.<\/p>\n

PYC says it remains on track to realise its objective of progressing a third drug with disease-modifying potential into human studies before the end of 2024.<\/p>\n

Meanwhile, ADOA is a progressive and irreversible blinding eye disease and affects approximately 1 in every 35,000 people, representing a market size of ~$2 billion per annum.<\/p>\n

ADOA is caused by a mutation in one copy of the OPA1 gene and in ~85% of patients. This leads to insufficient levels of OPA1 gene expression to support normal cellular function in the retinal ganglion cells of the eye.<\/p>\n

The abnormal function of the affected cells due to the OPA1 deficiency causes cell stress and ultimately cell death.<\/p>\n

\u00a0<\/p>\n

Imugene advances Phase 1 clinical trial<\/h2>\n

Imugene (ASX:IMU)<\/a><\/strong> surged 15% this morning after providing a clinical trial update of its Phase 1 MAST (Metastatic Advanced Solid Tumours)<\/strong> trial evaluating its novel cancer-killing virus, CF33-hNIS (VAXINIA)<\/strong>.<\/p>\n

In the last announcement last week, Imugene reported that it has cleared cohort 4 of the intravenous (IV) arm of the monotherapy dose escalation study, as well as IV cohort 2 of the combination study where VAXINIA is administered with checkpoint inhibitor drug, pembrolizumab (KEYTRUDA)<\/strong>.<\/p>\n

Imugene announced today that Cohort 5 of the IV arm for the monotherapy dose escalation is now open, as is IV cohort 3 of the combination study.<\/p>\n

Twenty-five patients were evaluable (received at least their first scan at day 42) and seven patients have their first scan still pending.<\/p>\n

Of the evaluable patients the BOR (best overall response) were: one Complete Response (CR), one Partial Response (PR), 16 Stable Disease (SD), showing patients had control and stability of their cancer, and eight progressive disease (PD).<\/p>\n

Importantly, early results from six patients with gastrointestinal cancers who received CF33-hNIS alone including two colorectal cancer, two bile duct, one pancreatic and one liver cancer showed positive treatment effects, with a disease control rate of 75%.<\/p>\n

Trial expansion is now planned for 10 patients with bile duct cancers.<\/p>\n

\u00a0<\/p>\n

Cleo\u2019s cancer test peer reviewed<\/h2>\n

Results from Cleo Diagnostics\u2019 (ASX:COV)<\/a><\/strong> first clinical validation study of the CleoDX Triage Test<\/strong>, performed in a 334 patient cohort, have been published in the peer-reviewed journal \u201cCancers\u201d.<\/p>\n

The article, entitled \u2018A novel predictive multi-marker test for the pre-surgical identification of ovarian cancer\u2019,<\/em> provides a detailed overview of the high performance of Cleo\u2019s ovarian cancer diagnostics test.<\/p>\n

The article concluded that Cleo\u2019s ovarian cancer test was highly accurate with 95% sensitivity and 95% specificity.<\/p>\n

The test also correctly discriminated malignant from benign samples, and was superior to current clinical methods.<\/p>\n

Cleo says peer review provides important validation of Cleo\u2019s technology and commercial strategy, which is targeting the surgical triage market where accurate and sensitive identification of malignant tumours is essential.<\/p>\n

\u00a0<\/p>\n

Share prices today:<\/h2>\n\n

\ufeff<\/span><\/span>
\n<\/span><\/p>\n

The post ASX Health Stocks: PYC on the same page with FDA, Cleo\u2019s cancer test peer-reviewed<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"

PYC to take ADOA drug to human clinical trials Imugene provides update of its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial Cleo\u2019s CleoDX Triage [more…]<\/a><\/p>\n","protected":false},"author":0,"featured_media":994,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-993","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-finance"],"yoast_head":"\nASX Health Stocks: PYC on the same page with FDA, Cleo\u2019s cancer test peer-reviewed - Economic Herald<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/economicherald.net\/?p=993\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ASX Health Stocks: PYC on the same page with FDA, Cleo\u2019s cancer test peer-reviewed - 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