Tag: Investigational

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Healthcare

OPTIMIZE study reports lowest TLR ever achieved in an Investigational Device Exemption (IDE) study with Svelte Medical System’s bioresorbable coated drug-eluting coronary stent

OPTIMIZE Pivotal Study 1 Year Outcomes Announced at TCT Connect

NEW PROVIDENCE, N.J.–(BUSINESS WIRE)–The Svelte® Drug-Eluting Stent (DES) achieved 1.5% clinically-driven Target Lesion Revascularization (TLR) at 1 year, the lowest ever reported in an Investigational Device Exemption (IDE) clinical study. Primary and secondary endpoint outcomes of the OPTIMIZE IDE study, designed to assess the safety and efficacy of the Svelte DES Integrated Delivery System (SLENDER IDS®) and Rapid Exchange (DIRECT RX®) platforms, were presented today during the Late-Breaking Trials session at TCT Connect.

OPTIMIZE randomized 1,639 subjects (1:1 SLENDER IDS or DIRECT RX DES vs. Xience® or Promus® DES) at 74 investigative sites in the US, Japan and Europe in support of US and Japan regulatory approvals. Under the prespecified study statistical analysis plan, the threshold for non-inferiority of 1 year Target Lesion Failure (TLF) using an absolute non-inferiority margin was not quite met (p=0.034 with 0.025 the prespecified threshold for non-inferiority). Unprecedented Target Vessel Myocardial Infarction (TVMI) rates of 8.8% were observed across both treatment groups, driven by the frequent use of high-sensitivity troponin biomarkers during peri-procedural assessments, leading to overall TLF of 9.9%, nearly double the expected rate and effectively underpowering the study. Non-inferiority of the Svelte DES compared to the Xience and Promus DES was clearly established in independent analyses of the OPTIMIZE results using either a comparable relative non-inferiority margin with the protocol definition of MI (p=0.009), or the SCAI definition of MI (p=0.003), which specifically accounts for high-sensitivity troponin use in the assessment of peri-procedural TVMI.

Dean Kereiakes, M.D., F.A.C.C., the Medical Director at The Christ Hospital, Lindner Research Center in Cincinnati, Ohio and co-principal investigator of the OPTIMIZE study stated, “The Svelte DES went head-to-head against the gold standard for DES and demonstrated exceptionally low TLR and stent thrombosis rates at 1 year. I regard the high TVMI rates observed in this study as artifact. When nearly 1 in 3 subjects assessed using high-sensitivity troponin assays is counted as TVMI across both treatment groups (including previously studied and highly regarded DES as the control), it is clear the protocol definition of TVMI, and not clinically meaningful TVMI, plagued this study.”

“The high TLF reported in both OPTIMIZE treatment groups is driven by the 25% of study subjects assessed peri-procedurally with high-sensitivity-troponin. These subjects accounted for 80% of all study TVMIs, yet 96% of them had no ECG changes and 88% were discharged post-procedure without delay, data that are not indicative of true clinical TVMI,” added Sunil Rao, M.D., F.A.C.C., Professor of Medicine at Duke University in Durham, North Carolina and co-principal investigator of the OPTIMIZE study. “With definition-driven TVMI placed into appropriate context, it’s exciting to see the exceptional clinical outcomes achieved in OPTIMIZE with 79% of subjects undergoing TRI. The low profile of the Svelte DES, and especially SLENDER IDS, facilitates TRI. The significantly lower access site hematoma rates and strong 1 year clinical results in TRI subjects should be of interest to radial specialists seeking to downsize catheters and improve patient care.”

Direct stenting was undertaken in 30% of OPTIMIZE subjects, with 96% device success rates observed. Ronald Caputo, M.D., F.A.C.C., an interventional cardiologist at Levine Heart & Wellness in Naples, Florida and top-5 user of SLENDER IDS for direct stenting in the OPTIMIZE study stated, “SLENDER IDS offers a unique low-profile option especially attractive to radial operators. It and DIRECT RX are extremely deliverable stents. I was very impressed with their performance during the study and exceptional 1 year clinical outcomes.” Investigators with prior experience direct stenting with SLENDER IDS in Europe also realized significant reductions in procedure, device and fluoroscopy times, as well as radiation exposure, compared with direct stenting using control DES.

SLENDER IDS and DIRECT RX utilize the same low profile, highly conformable stent with a new class of bioresorbable sirolimus-eluting drug carrier designed to minimize inflammation and promote vessel healing. Both SLENDER IDS and DIRECT RX hold CE Mark certification and are commercially available in Europe.

“We are deeply grateful to each and every one of the patients, investigative team members and support personnel contributing to the OPTIMIZE study. Our highly differentiated platforms bring a new and unique approach to coronary stenting which improves procedural efficiency while enhancing patient outcomes and comfort, delivering value to all constituents – patients, physicians, providers and payers,” said Jack Darby, President and CEO of Svelte Medical Systems.

About Svelte Medical Systems

Headquartered in New Providence, New Jersey, Svelte Medical Systems (www.sveltemedical.com) is a privately-held company engaged in the development of highly deliverable balloon expandable stents. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits, are forward-looking statements. A number of risks and uncertainties, such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the company’s products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings, could cause actual events to adversely differ from the expectations indicated in these forward-looking statements.

Contacts

Jack Darby

President and CEO

Svelte Medical Systems, Inc.

jdarby@sveltemedical.com
(908) 264-2012

Categories
Healthcare

TYME announces outcome of interim futility review for HopES Sarcoma Phase II study

  • Principal Investigator of the HopES Sarcoma Study Recommended Continuation of the Trial

BEDMINSTER, N.J.–(BUSINESS WIRE)–$TYME—Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced today a positive outcome of an interim futility review for the HopES Sarcoma Phase II clinical trial that is evaluating TYME’s lead cancer metabolism-based candidate, SM-88, as a potential oral treatment for patients with Ewing’s Sarcoma and other high-risk sarcomas.

“It is evident that the salvage cohort will pass the futility test and meet the criteria for expansion,” said Sant Chawla, M.D., founder of the Sarcoma Oncology Center, Santa Monica, CA and principal investigator for the HopES Sarcoma trial.

The interim futility review was completed in late July and, based on the analysis of the data and recommendations of Dr. Sant Chawla, the study will proceed with the current trial design as planned. The next major milestone in the HopES Sarcoma trial is expected in calendar year 2021. Sarcomas represents a great unmet medical need and significant opportunity for all stakeholders. There are more than 12,000 patients diagnosed each year without meaningful treatment options.

“We are pleased to have reached this important point in the HopES Sarcoma trial and now await the final results of the trial to determine the potential of oral SM-88 in high-risk sarcomas in an effort to improve the lives of these patients with, what we believe could be, a better safer approach,” said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at TYME. “To date, SM-88 has demonstrated encouraging tumor responses in 15 different cancers across four separate studies with minimal serious grade 3 or higher adverse events.”

The HopES Sarcoma trial is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88, with the conditioning agents methoxsalen, phenytoin and sirolimus, in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The first cohort will evaluate oral SM-88 as maintenance monotherapy following standard primary or palliative treatments for Ewing’s sarcoma patients with a high risk of relapse or disease progression. The second cohort will determine the clinical benefits of SM-88 as salvage monotherapy for patients with clinically advanced sarcomas. Patient dosing began in January 2020. The Joseph Ahmed Foundation is providing funding and patient support for this investigator-initiated Phase II (HopES) trial of SM-88 in patients with previously treated metastatic sarcoma, sponsored by the Sarcoma Oncology Research Center. The primary objectives are to measure efficacy events, including overall response, stable disease and progression free survival. Secondary objectives include duration of response, overall survival, clinical benefit rate using response evaluation criteria in solid tumors (RECIST 1.1), and incidence of treatment-emergent adverse events. Learn more at TYMETRIALS.com.

About Sarcomas and Ewing’s Sarcoma

Sarcomas are rare cancers in adults but are more common in children. There are approximately 12,0001 new sarcoma cases annually in the U.S. alone. There are many “subtypes” of sarcoma, as it can arise in many tissue structures throughout the body (nerves, muscles, joints, bone, fat, blood vessels – collectively referred to as the body’s “connective tissues”). Sarcomas are most frequently found in the limbs, as this is where the majority of the body’s connective tissues are found but can also present within the sites of more “common” cancers (e.g., breast sarcoma, stomach sarcoma, lung sarcoma, ovarian sarcoma, etc.). Sarcoma cancers often grow hidden deep in the body and are often diagnosed when the tumor size limits effective treatment options.

Ewing’s sarcoma is a primary bone cancer within a group of cancers known collectively as the Ewing’s sarcoma family of tumors. Ewing’s sarcoma is a type of tumor that forms in the bone or soft tissue. It is a rare type of cancer that is often overlooked and receives minimal recognition and research funding. Although Ewing’s sarcoma is typically a pediatric cancer, (it accounts for 30% of bone cancers in children), it can also be found in adults. The most commonly affected areas include the pelvis, thigh, lower leg, upper arm, and chest wall.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease. Learn more.

About the Joseph Ahmed Foundation

The Joseph Ahmed Foundation (JAF) is a 501(c)(3) non-profit organization that was founded in 2016 by the family of Joseph Ahmed, who lost his courageous battle with Ewing’s Sarcoma eight months after his diagnosis on September 1, 2014, at the age of 16. Through their tragic loss and grief, Joseph’s loved ones established the Joseph Ahmed Foundation which is dedicated to raising public awareness for the importance of early detection of the disease, and the urgent need of funding for research and development of innovative treatment and therapies to treat Ewing’s Sarcoma and other forms of pediatric cancer. JAF’s mission is to provide resources for research programs and support services through fundraising, philanthropic donations, corporate sponsorship and grants. JAF is comprised of passionate board members and volunteers who all share the same vision, finding a cure. The foundation can be reached at 212-867-8667. The global website is www.thejosephahmedfoundation.org

About Tyme Technologies

Tyme Technologies, Inc., is an emerging biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system. For more information, visit www.tymeinc.com. Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.

Forward-Looking Statements/Disclosure Notice

In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidates, including SM-88, and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned preclinical and clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such as “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” or “anticipates,” and similar words including their use in the negative or by discussions of future matters such as effect of the novel coronavirus (COVID-19) pandemic and the associated economic downturn and impacts on the Company’s ongoing preclinical and clinical trials and ability to analyze data from those trials, the cost of development and potential commercialization of our lead drug candidate and of other new products, expected releases of interim or final data from our clinical trials, possible collaborations, the timing, scope and objectives of our ongoing and planned clinical trials and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of TYME’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the severity, duration, and economic impact of the COVID-19 pandemic; that the information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply and the ability to achieve adequate clinical study design and start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final data from any clinical trial may differ from prior or preliminary study data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on May 22, 2020, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission available at www.sec.gov.

The information contained in this press release is as of its release date and TYME assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.

1 https://www.cancer.org/cancer/soft-tissue-sarcoma/about/key-statistics.html

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For Investor Relations & Media Inquiries:

Investor Relations

1-212- 461-2315

investorrelations@tymeinc.com
media@tymeinc.com

Categories
Healthcare

Merck and Hanmi Pharmaceutical enter into licensing agreement to develop Efinopegdutide, an investigational once-weekly therapy for nonalcoholic steatohepatitis (NASH)

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Hanmi Pharmaceutical today announced that the companies have entered into an exclusive licensing agreement for the development, manufacture and commercialization of efinopegdutide (formerly HM12525A), Hanmi’s investigational once-weekly glucagon-like peptide-1 (GLP-1)/glucagon receptor dual agonist, for the treatment of nonalcoholic steatohepatitis (NASH).

“Data from phase 2 studies has provided compelling clinical evidence that warrants further evaluation of efinopegdutide for the treatment of NASH,” said Dr. Sam Engel, associate vice president, Merck clinical research, diabetes and endocrinology, Merck Research Laboratories. “We continue to build on our proud legacy of developing meaningful medicines for the treatment of metabolic diseases and look forward to advancing this candidate.”

Under the agreement, Merck will be granted an exclusive license to develop, manufacture and commercialize efinopegdutide in the United States and globally. Hanmi will receive an upfront payment of $10 million and is eligible to receive milestone payments up to $860 million associated with the development, regulatory approval and commercialization of efinopegdutide, as well as double-digit royalties on sales of approved product. Hanmi retains an option to commercialize efinopegdutide in Korea.

“This licensing agreement supports Hanmi’s goals of developing and providing innovative therapies to the patients who need them,” said Dr. Se Chang Kwon, CEO and president, Hanmi Pharmaceutical. “We believe that Merck’s strong scientific expertise in metabolic diseases makes it well positioned to advance this candidate forward and maximize its potential for patients around the world.”

About efinopegdutide

Efinopegdutide is a GLP-1/glucagon receptor dual agonist, which activates both the GLP-1 and glucagon receptors. The safety and efficacy of efinopegdutide has previously been evaluated in multiple Phase 1 and Phase 2 clinical trials, including for the treatment of severely obese individuals with and without type 2 diabetes mellitus.

About Merck

For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

About Hanmi Pharmaceutical

Hanmi Pharmaceutical is a Korea-based pharmaceutical company, fully integrated with strong focus in R&D which is strategically designed in 3 major fields: 1) Biologics: LAPSCOVERY platform applied long-acting pipelines. Key targeting areas are diabetes and obesity; 2) NCE: Mainly oncology targeted pipelines; and 3) Fixed-dose combination programs. The company has worked closely with global partners on various co-developments and collaborations. Hanmi continues to further expand through “Open Innovation Strategy” by finding potential partners for innovative solutions.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2019 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Merck Media:

Pam Eisele

(267) 305-3558

Sienna Choi

(908) 740-1256

Merck Investors:

Peter Dannenbaum

(908) 740-1037

Michael DeCarbo

(908) 740-1807