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News Article | February 23, 2017

— Summary The report provides comprehensive information on the therapeutics under development for Oral Mucositis, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Oral Mucositis and features dormant and discontinued projects. Report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Scope - The report provides a snapshot of the global therapeutic landscape of Oral Mucositis - The report reviews pipeline therapeutics for Oral Mucositis by companies and universities/research institutes based on information derived from company and industry-specific sources - The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages - The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved Oral Mucositis therapeutics and enlists all their major and minor projects - The report assesses Oral Mucositis therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type - The report summarizes all the dormant and discontinued pipeline projects - The report reviews latest news related to pipeline therapeutics for Oral Mucositis Reasons to buy - Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Identify and understand important and diverse types of therapeutics under development for Oral Mucositis - Identify potential new clients or partners in the target demographic - Develop strategic initiatives by understanding the focus areas of leading companies - Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics - Devise corrective measures for pipeline projects by understanding Oral Mucositis pipeline depth and focus of Indication therapeutics - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope - Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline Table of Content: Key Points Table of Contents 2 List of Tables 5 List of Figures 6 Introduction 7 Oral Mucositis Overview 8 Therapeutics Development 9 Pipeline Products for Oral Mucositis - Overview 9 Pipeline Products for Oral Mucositis - Comparative Analysis 10 Oral Mucositis - Therapeutics under Development by Companies 11 Oral Mucositis - Therapeutics under Investigation by Universities/Institutes 12 Oral Mucositis - Pipeline Products Glance 13 Late Stage Products 13 Clinical Stage Products 14 Early Stage Products 15 Oral Mucositis - Products under Development by Companies 16 Oral Mucositis - Products under Investigation by Universities/Institutes 17 Oral Mucositis - Companies Involved in Therapeutics Development 18 Aldeyra Therapeutics, Inc. 18 Cellceutix Corporation 19 Colby Pharmaceutical Company 20 Daewoong Pharmaceutical Co., Ltd. 21 Galera Therapeutics, Inc. 22 Intrexon Corporation 23 Onxeo SA 24 Otsuka Holdings Co., Ltd. 25 ProCertus BioPharm Inc. 26 Soligenix, Inc. 27 …Continued For more information, please visit

Fahl W.E.,University of Wisconsin - Madison | Fahl W.E.,ProCertus BioPharm
International Journal of Cancer | Year: 2014

Topical application of the alpha adrenergic vasoconstrictors norepinephrine, phenylephrine or epinephrine to skin or mucosa in alcohol:water-based delivery vehicles minutes before irradiation has recently been shown to protect skin and mucosa cells against radiotherapy-induced toxicities in both preclinical and clinical studies. The protective mechanism is thought to involve transient skin or mucosal vasoconstriction with secondary, transient hypoxia and associated radioprotection. Regarding possible protection of tumor cell nests within the radiotherapy field, the endothelial cell-abnormal stroma constructed blood vessels generally found in human tumors commonly lack adrenergic receptor-containing smooth muscle cells that are required to achieve vasoconstriction. Consistent with this, we show here that topical application of norepinephrine or phenylephrine to broken or intact skin over human Cal-27 or A-431 xeonograft, or mouse solid L1210 allograft tumors growing subcutaneously in nude mice, showed no effect upon radiation-induced tumor growth inhibition. Although vasoconstrictor-induced nude mouse skin blanch was seen minutes after topical application of 600 mM norepinephrine, no blanching was seen within the A-431 xenograft tumors. Radiation dermatitis was severe 11 days post-irradiation (2 × 13.8 Gy) in the irradiated field containing xenograft tumors in mice that received topical delivery vehicle, but was absent in mice that received topical norepinephrine. Topical vasoconstrictor-conferred prevention of radiation dermatitis without discernible radioprotection of three histologically diverse xenograft or allograft tumors supports further development of the topical vasoconstrictor therapeutic strategy in humans. © 2014 UICC.

Soref C.M.,ProCertus BioPharm | Hacker T.A.,University of Wisconsin - Madison | Fahl W.E.,ProCertus BioPharm | Fahl W.E.,University of Wisconsin - Madison
International Journal of Radiation Oncology Biology Physics | Year: 2012

Purpose: A new aminothiol, PrC-210, was tested for orally conferred radioprotection (rats, mice; 9.0 Gy whole-body, which was otherwise lethal to 100% of the animals) and presence of the debilitating side effects (nausea/vomiting, hypotension/fainting) that restrict use of the current aminothiol, amifostine (Ethyol, WR-2721). Methods and Materials: PrC-210 in water was administered to rats and mice at times before irradiation, and percent-survival was recorded for 60 days. Subcutaneous (SC) amifostine (positive control) or SC PrC-210 was administered to ferrets (Mustela putorius furo) and retching/emesis responses were recorded. Intraperitoneal amifostine (positive control) or PrC-210 was administered to arterial cannulated rats to score drug-induced hypotension. Results: Oral PrC-210 conferred 100% survival in rat and mouse models against an otherwise 100% lethal whole-body radiation dose (9.0 Gy). Oral PrC-210, administered by gavage 30-90 min before irradiation, conferred a broad window of radioprotection. The comparison of PrC-210 and amifostine side effects was striking because there was no retching or emesis in 10 ferrets treated with PrC-210 and no induced hypotension in arterial cannulated rats treated with PrC-210. The tested PrC-210 doses were the ferret and rat equivalent doses of the 0.5 maximum tolerated dose (MTD) PrC-210 dose in mice. The human equivalent of this mouse 0.5 MTD PrC-210 dose would likely be the highest PrC-210 dose used in humans. By comparison, the mouse 0.5 MTD amifostine dose, 400 μg/g body weight (equivalent to the human amifostine dose of 910 mg/m 2), when tested at equivalent ferret and rat doses in the above models produced 100% retching/vomiting in ferrets and 100% incidence of significant, progressive hypotension in rats. Conclusions: The PrC-210 aminothiol, with no detectable nausea/vomiting or hypotension side effects in these preclinical models, is a logical candidate for human drug development to use in healthy humans in a wide variety of radioprotection settings, including medical radiation, space travel, and nuclear accidents. © 2012 Elsevier Inc.

Soref C.M.,University of Wisconsin - Madison | Fahl W.E.,University of Wisconsin - Madison | Fahl W.E.,ProCertus BioPharm
International Journal of Cancer | Year: 2015

In a new strategy, we sought to determine whether topically applied vasoconstrictor, with its accompanying transient skin hypoxia and exclusion of systemic drug, would prevent or suppress radiotherapy or chemotherapy-induced alopecia. Topical vasoconstrictor was applied to 1-cm2 skin patches on the backs of 10-day-old rats and minutes later they received either 7.1 gray (Gy) whole-body radiation or systemic N-nitroso-N-methylurea (MNU) or Cytoxan. The degree of alopecia was scored 10 days later by visual assessment (% coat retention) and hair follicle histologic analysis. Topical application of epinephrine or norepinephrine in an alcohol:water delivery vehicle induced clear skin blanch, and in a dose-dependent manner, topical epinephrine or norepinephrine (20-1,000 mM) applied before 7.1 Gy irradiation conferred 95% of coat retention in the treated skin patches versus 0% coat retention in vehicle controls, or in skin outside the treated patches. By histology, small numbers of dystrophic hair follicles were observed in hairless skin versus the normal density of anagen follicles in the immediately adjacent, drug-protected skin patches at day 20; protected coats were retained into adulthood. Topical epinephrine or norepinephrine before systemic MNU (30 ug/gm body weight) conferred up to 95% of coat retention in treated skin patches versus 0% coat retention elsewhere. Epinephrine-conferred % coat retention dropped to 16% in rats that received systemic Cytoxan, a drug whose plasma half-life is at least 8- to 10-fold longer than MNU. A general strategy is discussed for the use of topical epinephrine or norepinephrine in the clinic to provide an inexpensive and convenient strategy to prevent cancer therapy-induced alopecia. What's new? Nearly two-thirds of cancer patients who receive chemotherapy experience chemotherapy-induced hair loss, or alopecia. To improve clinical management of alopecia, the present study explored a new strategy, based on topical application of a vasoconstrictor prior to radiation or chemotherapy. In a rat alopecia model, application of epinephrine or norepinephrine before radiation or chemotherapy was found to confer up to 95% coat retention. Topical application of the vasoconstrictors induced a visible skin blanch in neonate rats, with protected coat growth occurring at the blanched sites. The results support further development of a topical vasoconstrictor strategy for clinical use. © 2014 UICC.

Copp R.R.,ProCertus BioPharm | Peebles D.D.,ProCertus BioPharm | Fahl W.E.,University of Wisconsin - Madison | Fahl W.E.,ProCertus BioPharm
Bioorganic and Medicinal Chemistry Letters | Year: 2011

The synthesis, growth inhibition and radioprotective activity of the PrC-210 aminothiol, 3-(methylamino)-2-((methylamino)methyl)propane-1-thiol, and its polyamine and thiolated polyamine progenitors are reported. All of the molecules significantly inhibited growth of cultured normal human fibroblasts. The combination of an ROS-scavenging thiol group and a positively charged alkyl-amine backbone provided the most radioprotective aminothiol molecule. © 2011 Elsevier Ltd. All rights reserved.

Peebles D.D.,ProCertus BioPharm | Soref C.M.,ProCertus BioPharm | Copp R.R.,ProCertus BioPharm | Thunberg A.L.,ProCertus BioPharm | And 2 more authors.
Radiation Research | Year: 2012

To identify new aminothiol radioprotectors that are active when applied topically and have fewer side effects when administered systemically, a new family of aminothiol radioprotectors was designed and synthesized. Three key elements in the aminothiol design were, (1) small size for efficient transmembrane diffusion, (2) positive charged amines in alkyl backbone for strong ionic interaction with DNA backbone, and (3) a perpendicular, alkyl side-chain with a terminal thiol that is projected away from the DNA backbone to enable reactive oxygen species scavenging around DNA. Several in vitro assays were used to characterize the prototype aminothiol, PrC-210, for efficacy: protection against reactive oxygen species-induced plasmid DNA nicking, mass spectrometry to detect aminothiol-reactive oxygen species by-products, S. typhimurium mutagenesis, human cell growth inhibition, Western blot for p21 expression, and FACS analysis. Additionally, two in vivo assays were used to assess radioprotective efficacy; a Sprague-Dawley rat dorsal skin radiodermatitis assay was developed to screen for aminothiol efficacy when topically applied, and ICR mouse survival was scored after systemic PrC-210 administration and whole-body radiation. PrC-210 efficiently scavenged reactive oxygen species and completely protected supercoiled plasmid DNA against reactive oxygen species-induced damage. Neither PrC-210 nor its analog PrC-211 were bacterial mutagens. In cell culture, PrC-210 application to diploid human fibroblasts showed: (1) inhibition of cell growth with an IC70 of 4.1 mM, (2) induced levels of p21 expression, and (3) a G1/S-cell cycle block that was reversed after washout of PrC-210-containing medium. In rodents, PrC-210 was an effective radioprotector showing: (1) complete prevention of Grade 23 radiodermatitis when applied topically (370 mM in ethanol:propylene glycol:water solution) prior to skin irradiation, (2) complete prevention of Grade 23 radiodermatitis when administered by i.p. injection (200 μg/g of body weight) before skin irradiation, (3) 100 survival of mice from an otherwise 100 lethal dose of whole-body radiation (8.75 Gy) when administered by i.p. injection (252 μg/g of body weight 0.5 × maximum tolerated dose) before irradiation, and (4) a dose reduction factor of 1.6, the same as amifostine. These data suggest that the PrC-210 aminothiol is a plausible candidate for drug development as a human pre-exposure radioprotector. © 2012 by Radiation Research Society.

ProCertus BioPharm | Date: 2012-10-26

Dermatological pharmaceutical products; Inhaled pharmaceutical preparations for the treatment of respiratory diseases and disorders; Pharmaceutical preparations and substances for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmic, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders; Pharmaceutical preparations for use in chemotherapy; Pharmaceutical preparations for use in dermatology; Pharmaceutical preparations for use in urology; Pharmaceutical preparations for wounds; Pharmaceutical products for ophthalmological use; Pharmaceutical products for the prevention and treatment of cancer.

ProCertus BioPharm | Date: 2012-03-09

Aspects of the present disclosure are directed to formulations that permit the solubilization and long term, stable storage of adrenergic agonist vasoconstrictors in organic solvents. Provided herein are formulations comprising about 250 mM to about 3000 mM of an acid salt of an adrenergic agonist vasoconstrictor dissolved in a pharmaceutically acceptable topical delivery vehicle comprising a water miscible, organic solvent having a water content of less than 40% by weight. Also provide are methods for using and kits containing such formulations.

DUBLIN--(BUSINESS WIRE)--Research and Markets ( has announced the addition of the "Radiodermatitis - Pipeline Review, H1 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Radiodermatitis, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Radiodermatitis and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

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