Latest news with #GLP
Yahoo
5 days ago
- Business
- Yahoo
Hoth Therapeutics Reports Positive Preclinical Safety Data for Cancer Fighting HT-KIT -- Dose-Dependent Liver Activity with No Observed Toxicity Supports IND Pathway
HOTH ALERT: Hoth Therapeutics Reports Positive Preclinical Safety Data for HT-KIT — Dose-Dependent Activity, No Toxicity, IND on Deck HOTH announces strong preclinical data for HT-KIT showing dose-dependent liver activity with zero observed toxicity – key milestone as the company prepares for IND filing. Study Results: Liver weight increased from 1.11g → 1.32g across 0 → 3.0 mg/kg No adverse effects on kidney, spleen, or thymus 100% clean safety profile — no visible lesions or gross pathology Validates safety of HT-KIT in vivo Robb Knie, CEO: "These results strengthen our confidence in HT-KIT as we advance toward clinical trials. A strong safety signal with dose responsiveness and no toxicity gives us a clear path forward." NEW YORK, June 18, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company developing innovative therapeutics for rare and inflammatory diseases, today announced encouraging preclinical results from a multi-dose study of HT-KIT, its investigational oncology candidate targeting the c-KIT pathway. The study demonstrated a clear dose-responsive effect on liver mass with no observable toxicity or organ pathology, reinforcing the favorable safety profile of HT-KIT as the Company prepares for further toxicology studies and regulatory advancement. Key Preclinical Findings (HT-KIT): Liver weight increased from 1.11g at 0 mg/kg to 1.32g at 3.0 mg/kg, consistent with pharmacological engagement. Kidney and spleen weights remained stable, indicating no off-target or systemic toxicity. Thymus and other critical organ weights were within normal range across all groups. No gross pathology or visible lesions observed in any treated animal. "These clean and compelling safety results validate our confidence in HT-KIT," said Robb Knie, CEO of Hoth Therapeutics. "A dose-dependent biological signal without organ damage strongly supports our plan to move forward with GLP studies and an IND submission." Hoth Therapeutics expects to initiate GLP toxicology studies, with plans to submit an Investigational New Drug (IND) application soon after. About Hoth Therapeutics, Inc. Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit . Forward-Looking Statement This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of any health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the company believes that the expectations reflected in the forward-looking statements are reasonable, the company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. Investor Contact:LR Advisors LLCEmail: investorrelations@ (678) 570-6791 View original content to download multimedia: SOURCE Hoth Therapeutics, Inc.
The Print
5 days ago
- The Print
Telangana cops book Palamur Biosciences on animal cruelty charge after PETA ‘house of horrors' exposé
On 10 June, in a post on X, PETA India revealed large-scale animal abuse at the Telangana-based Palamur Biosciences Pvt Ltd, one of India's largest government-registered contract laboratories. The information provided by whistleblowers alleged that the facility was killing dogs and other animals without reason and with extreme cruelty, overcrowding them, and subjecting them to social isolation, among other things. PETA India, while asserting that such instances were not isolated but reflect a 'recurring pattern' in the global animal experimentation industry, called on the government to shut down the facility, which it dubbed a 'house of horrors,' and end animal testing in India. New Delhi: Police in Telangana's Mahabubnagar Tuesday booked Palamur Biosciences Pvt Ltd, a preclinical contract research organisation, on a complaint filed by People for the Ethical Treatment of Animals (PETA) India which last week cited revelations by a whistleblower to allege a pattern of animal cruelty at the firm's laboratory. The whistleblowers stepped forward to share video footage, images and testimonies after PETA India filed official complaints with authorities about the likely unauthorised testing on rhesus macaques at the same lab in October 2024, the report said. The lab claims it is 'one of the largest preclinical service providers' and tests drugs, pesticides, and medical devices on animals. It also runs a beagle breeding facility, where, according to the report, 1,500 beagles were being kept in a space for about 800. Dr Anjana Aggarwal, PETA scientist and research policy adviser, told ThePrint, 'This is not an isolated incident but rather business as usual, where systemic cruelty runs rampant.' 'Past investigations by regulatory bodies have revealed similar abuse and neglect of animals at other Indian labs, and PETA entities around the world have documented this as a recurring pattern in the global animal experimentation industry,' Dr Aggarwal added. In its report, PETA India had said it submitted a complaint with CCSEA, statutory body under the Prevention of Cruelty to Animals Act, 1960, as well as the CDSCO, the industry regulator for cosmetics, pharmaceuticals and medical devices. PETA India has also reached out to the National GLP Compliance Monitoring Authority (NGCMA), under the Union government's department of science and technology (DST), which issues Good Laboratory Practice (GLP) certificates. According to the body's website, 'GLP-compliance certification is voluntary in nature.' ThePrint reached Palamur Biosciences, Committee for the Purpose of Control And Supervision of Experiments on Animals (CCSEA), Central Drugs Standard Control Organisation (CDSCO) and National Good Laboratory Practice Compliance Monitoring Authority (NGCMA) for comment over email but had not received a response by the time of publication. The report will be updated if and when a response is received. Also Read: Indian laws are letting animals down every day. It's a legal, moral, ethical issue Filing complaints only the first step Asked if flagging the issue to relevant authorities was enough, Aggarwal said, 'Filing complaints with regulatory bodies is only the first step. What matters is the enforcement of existing standards. Without swift and meaningful punitive action, cruelty to animals thrives unchecked.' She called for the lab in Telangana to be shut down, saying, 'We urge government regulators to end the torment of animals imprisoned at Palamur Biosciences. Anything less than the facility's permanent shutdown is a green light for abuse.' To better regulate such facilities, she said, 'authorities must conduct genuinely unannounced inspections without advanced notice, ensure full access to historical records and CCTV footage, protect whistleblowers, and impose serious penalties—not mere warnings—for violations.' India, she added, needs to get out of the 'archaic, cruel, and unscientific animal experimentation business,' citing the example of the the US Food and Drug Administration (FDA) and the US National Institute of Health (NIH) that 'have already begun the long-overdue transition away from animal testing'. 'Notably, earlier this year, the NIH closed down its beagle laboratory, and the US Navy ended all its testing on dogs and cats, which stands in stark contrast to Palamur Biosciences' breeding and testing on beagles and other animals,' Aggarwal said. What PETA India report said—Inside the 'house of horrors' The report, which PETA said was a first-of-its-kind whistleblower exposé, documented the neglect of dogs, pigs, and monkeys used by Palamur Biosciences. The lab is located in Karvena village, Mahabubnagar district. A whistleblower said that, at the lab, being deemed 'useless' meant certain death for the animal. They shared several instances where animals were allegedly killed, including two involving sick dogs—one with a cherry eye and a beagle with a fungal infection. One whistleblower told PETA India that over 100 dogs were killed in a single incident simply because they were no longer considered 'useful'. According to the PETA report, animals were also being subjected to overcrowding and competition for food, resulting in extreme frustration and frequent fights that often caused serious injuries. Above all, basic treatment, proper wound cleaning, and pain management weren't provided by the company. Rough handling of dogs often led to fractures, the report said. Lab workers also showed cruelty while conducting testing, including studies where 'dogs were injected subcutaneously with test compounds'. 'According to a whistleblower, animals developed abscesses, ulcers, and signs of severe pain following these injections,' it said. A whistleblower alleged that, depending on the location of the abscess, further health issues were seen in the dogs. The report further claimed that the laboratory purchased Göttingen minipigs from Denmark, but does not have a license to breed them. When a minipig was found pregnant, the head veterinarian allegedly ordered the killing of the piglets through intracardiac injection. Despite a policy requiring Palamur to provide playtime for pigs, they are only permitted access to enrichment when customers are around, the report alleged. According to the allegations, among the wild rhesus macaques from Rajasthan, some tested positive for zoonotic pathogens, likely monkeypox. The company simply kept quiet and killed the monkeys, risking infection to others, the report claimed. Riju Chanda is an intern with ThePrint (Edited by Sanya Mathur) Also Read: Goldfish in perfume bottle, protected species on sale—DU students' report on horrors of Delhi pet shops
The Hindu
12-06-2025
- Health
- The Hindu
Palladam poultry units seek upgrade of facilities at lab in Panickampatti
Poultry units in and around Palladam are in anticipation of upgrade of facilities at Poultry Disease Diagnostic Laboratory (PDDL) of the Animal Husbandry Department at Panickampatti near Palladam, established about six years ago to carry out testing of feed and water samples. Out of ₹6.92 crore sanctioned for the PDDL, ₹4.24 crore was for the Poultry Disease Diagnosis Laboratory and ₹2.56 crore for establishing a laboratory for poultry feed testing, it is learnt. The PDDL was sanctioned with BSL (Bio-safety level) II and GLP (Good Laboratory Practice) system under the National Agricultural Development Programme. It was established with the intent of carrying out diagnosis of poultry diseases through conduct of post-mortem, testing of droppings, blood samples and other specimens for major diseases, including viral diseases such as New Castle Disease, Infectious Bursal Disease, Infectious Bronchitis, Avian Leucosis Complex, and common bacterial diseases like Salmonella, and parasitic infestations.. The collective request of the hundreds of poultry units for upgrade of the PDDL in Palladam was made known to Minister for Information and Publicity M.P. Saminathan, District Collector T. Christuraj and senior officials of the Animal Husbandry Department when they carried out an inspection of the facilities at the PDDL on Thursday. The poultry units, in particular, laid emphasis on establishment of incinerator to dispose of dead chicken, and adequacy of manpower and machinery at the PDDL. The PDDLs carry out sero monitoring and surveillance for poultry diseases, covering both commercial and back yard poultry farms. Strict vigil over mortality and transport of poultry in view of preparedness for avian influenza is one of the major responsibilities of these laboratories, sources in Tamil Nadu Veterinary and Animal Sciences University said. At present, the poultry units continue to depend on the PDDL at Namakkal for these tests. Once the PDDL at Palladam is upgraded with the required manpower and machinery, it will be equipped to test serum samples as preliminary screening for antibodies against avian influenza and forward the positive samples to referral laboratories for further confirmation. As per the 2019th census of the Animal Husbandry Department in Tiruppur region, poultry strength in the farm of backyard poultry was 10,97,579 and that of farm poultry 149,84,700. Tiruppur district is in the forefront in rearing of broiler birds under contract farming mainly in Palladam and Gudimangalam blocks, and Palladam has come to be known as a poultry hub with over 4,000 hatcheries and more than 50 broiler farms.
Business Wire
11-06-2025
- Business
- Business Wire
Harmony Biosciences Presents Preclinical Data Demonstrating Significant Wake-Promoting and Cataplexy-Suppressing Effects of BP1.15205 in Narcolepsy at SLEEP 2025
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the presentation of preclinical pharmacological effect data for BP1.15205, an investigational, highly potent, and potentially best-in-class orexin 2 receptor (OX2R) agonist, which demonstrated significant wake-promoting and cataplexy-suppressing effects in a standard transgenic mouse model of narcolepsy type 1. The data will be presented at the 39 th Annual Meeting of the Associated Professional Sleep Societies (APSS) 'SLEEP' on Wednesday, June 11, 2025, at 10:00 AM PDT in Seattle. 'We are encouraged by the robust preclinical data being presented at SLEEP, highlighting BP1.15205 as a potentially best-in-class OX2R agonist,' said Kumar Budur, MD, MS, Chief Medical and Scientific Officer at Harmony Biosciences. 'BP1.15205 is a new and unique chemical scaffold optimized for high potency that demonstrated statistically significant wake-promoting effects at very low doses administered orally in the standard transgenic mouse model. These findings are supportive of dosing flexibility to potentially treat all three central disorders of hypersomnolence at low doses, which could offer an optimized benefit / risk profile. The 3-month GLP toxicity study in two species revealed no concerning adverse events and supports a favorable safety and tolerability profile.' Orexin receptor functional studies showed that BP1.15205 is a highly potent, selective OX2R receptor agonist with no off-target effects expected and a >600-fold selectivity over human OX1R. BP1.15205 is orally bioavailable and has the potential for once-daily dosing. Absorption, distribution, metabolism, and excretion (ADME) properties and preliminary toxicology studies showed that BP1.15205 is a differentiated OX2R agonist drug candidate. In the GLP toxicity study, no adverse events or biochemical changes were observed following a 3-month treatment period at doses up to 300 mg/kg/day, pending histopathology data. An Investigational Medicinal Product Dossier (IMPD) application with the European Medicines Agency (EMA) is being completed for BP1.15205. A first-in-human study is planned to begin in 2H 2025 with topline data anticipated in 2026. Additionally, an Investigational New Drug (IND) application for BP1.15205 will be filed with the U.S. Food and Drug Administration (FDA). 'We are very excited to advance our potentially best-in-class OX2R program and support the strategic expansion of our sleep-wake franchise. We are dedicated to investigating this potential new solution further with the hope of bringing a novel treatment to market that can help even more people with narcolepsy and other central disorders of hypersomnolence,' Budur added. The poster entitled, 'BP1.15205, a Novel Orexin-2 Receptor Agonist, Demonstrates Pharmacological Effects in a Mouse Model of Narcolepsy,' will be presented at P-38; Poster Board Number 1; on June 11, 2025, at 10:00 AM PDT. KEY FINDINGS FROM THE STUDIES INCLUDE: In Vitro Orexin Receptor Functional Studies: BP1.15205 is a highly potent agonist at OX2R receptors: EC 50 = 0.015 nM. BP1.15205 is highly selective for human OX2R receptors: >600-fold selectivity over human OX1R receptors. Minimal interspecies difference in agonist functional properties was observed between human and mouse orexin-2 receptors. In Vivo Pharmacology Studies: Single oral dose administration of BP1.15205 in transgenic mice at the beginning of the 12-hour dark period of a 24-hour light/dark cycle produced significant and dose-dependent increases in total wakefulness time and sleep latency at every dose tested beginning at 0.03 and 0.1 mg/kg, respectfully, as compared to vehicle-treated animals. Significant and dose-dependent decreases in the total number and duration of cataplexy-like episodes were measured following single dose, oral administration of BP1.15205 beginning at 1mg/kg, as compared to vehicle. About Narcolepsy Narcolepsy is a rare, chronic, debilitating neurological disease of sleep-wake state instability that impacts approximately 170,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy – its two cardinal symptoms – along with other manifestations of REM sleep dysregulation (hallucinations and sleep paralysis), which intrude into wakefulness. EDS is the inability to stay awake and alert during the day and is the symptom that is present in all people living with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin/orexin, a neuropeptide in the brain that supports sleep-wake state stability. This disease affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed. About Harmony Biosciences Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2025 net product revenue, expectations for the growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved, including ZYN002 and EPX-100; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche ('Bioprojet'); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe; and macroeconomic effects and changes in market conditions, including the impact of tariffs, inflation and the risk of recession. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 25, 2025, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
India.com
09-06-2025
- Business
- India.com
Authorities Crack Down on Boss IPTV and Affiliate Illegal IPTV Services: Users Warned of Criminal Charges and Deportation Risks
New Delhi: A major international crackdown has uncovered an extensive illegal Internet Protocol Television (IPTV) operation streaming pirated content across various digital platforms. Operating under brand names such as Boss IPTV, Guru IPTV, Tashan IPTV, Brampton IPTV, Vois IPTV, Indian IPTV, Punjabi IPTV, Edmonton IPTV, Boss Entertainment IPTV, and UltrastreamTV, this unlawful network has been implicated in severe copyright infringement and data privacy violations, According to police, these services have been illegally broadcasting premium Indian and international content including channels and programs from Star, Zee Network, Colors, Sony, Sun Network, ETV, Aha, Sonyliv, as well as global streaming platforms such as Netflix, Amazon Prime Video, Hulu, and international sports leagues—without securing proper licenses or permissions. Delivered through Android/Linux-based set-top boxes or via apps on smart devices, the illegal services were aggressively promoted online via social media, websites, and blogs, offering premium content at prices significantly below legal services. Government investigations reveal that these platforms do not pay content owners or platforms for rights, deeply harming the entertainment industry. The global South Asian broadcast sector loses an estimated $200–$300 million annually due to IPTV piracy, affecting licensed platforms like YuppTV,. In addition to economic damage, there are serious security concerns: pirated IPTV services often harvest user data—such as credit card information—and are linked to phishing scams, tax evasion, and potentially funding other illegal operations including drug trade and terrorism. Previously in 2021, following a complaint filed by YuppTV, the Faridabad Cyber Crime Branch conducted a raid on Boss IPTV operations in India, leading to the arrest of six individuals connected to the illegal piracy network. YuppTV has further filed a civil complaint in the United States District Court, represented by Goldstein Law Group, LLC ('GLP') targeting Boss IPTV and its affiliated entities. The complaint highlights severe violations of U.S. federal copyright law under 18 U.S.C. § 2319. According to GLP: 'Any subscriber using illegal IPTV pirate services… may be linked to copyright infringement, a crime under U.S. federal law. Convictions may result in felony charges, and non-citizens convicted of such offenses may be subject to deportation under U.S. law.' Recently, another similar case was reported by the Gandhinagar Cyber Crime Unit in Gujarat which arrested Mohammed Murtuza Ali, suspected to be the key figure behind another massive illegal IPTV operation known as Bos IPTV. Operating from Jalandhar, Punjab, Ali allegedly ran a piracy network that drew over five million subscribers and generated close to ₹700 crore (US $84 million) in annual revenue. Legal authorities suggest that to avoid the possibility of arrest and other penalties, all current users accessing pirated services immediately discontinue use and migrate to legal, licensed platforms such as YuppTV. Visit to obtain legal, authorized access to Indian content. For more information about the ongoing litigation and enforcement actions against Boss IPTV and related services, please visit: [Insert Litigation Info Link]
