Isarna Therapeutics GmbH

MUNICH--(BUSINESS WIRE)-- Isarna Therapeutics today announced upcoming oral presentations at the OIS Retina Innovation Summit on May 4th and the Association for Research in Vision and Ophthalmology (ARVO) Meeting on May 7th, both in Seattle, WA. Isarna’s Chief Medical Officer, Prof. Marion R. Munk, will present updated clinical data from its Phase 2 BETTER study evaluating the company’s lead program, ISTH0036. ISTH0036 is an RNA-based antisense molecule that blocks the production of transforming growth factor-beta (TGF-β), a leading driver of fibrosis in ophthalmic pathology. To date, the trial has reported a good safety pro ISTH0036 and efficacy in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) patients. The morphological data, analyzed using the AI-powered Discovery platform from RetinAI AG, showed the prevention of fibrosis and epithelial-mesenchymal transition together with a drying effect as a key differentiator to currently approved anti-angiogenic therapies, mostly targeting Vascular Endothelial Growth Factors (VEGF). “Since the initiation of the BETTER trial, we have continued to demonstrate ISTH0036’s overall potential in targeting a key function in the disease progression of AMD and DME,” commented Dr. Rene Rückert, MD, MBA, COO of Isarna Therapeutics. “We value the opportunity to present the recent findings from our ongoing clinical study to experts within the ophthalmology community.” The BETTER study is a parallel, open-label, two-segment Phase 2 clinical trial evaluating ISTH0036 in patients with wet AMD and DME. The study has begun investigating its primary endpoint, the reduction of retinal fluid and central macular thickness (CMT), as well as its secondary endpoint, the improvement of visual acuity (VA). Patients selected for the trials included both newly diagnosed patients and those who have already been treated with anti-VEGF therapeutics. The trial was designed in collaboration with Isarna’s expert advisory board and is currently being conducted by internationally renowned experts at clinical trial centers in Austria and India. About Isarna Isarna Therapeutics was built on profound knowledge in antisense oligonucleotide design and RNA technology and therapeutic development of this innovative compound class. Today, Isarna is developing a portfolio of antisense therapies targeting an emerging therapeutic field in human biology: TGF-β signaling. Precise modulation of TGF-β pathways using antisense therapy may result in safer and more effective treatment options for a broad range of indications. Currently, Isarna is focusing on ophthalmology; its lead compound, ISTH0036, is in Phase 2 clinical development in the blockbuster indications wet AMD and DME. In addition, Isarna has established a portfolio of antisense compounds addressing three important isoforms of TGF-β to treat fibrotic diseases, and various forms of cancer. View source version on businesswire.com: Contacts Isarna Prof. Marion R. Munk, CMO info@isarna-therapeutics.com Media Inquiries Trophic Communications Gretchen Schweitzer or Desmond James Phone: +49 151 678 59086 isarna@trophic.eu Source: Isarna Therapeutics View this news release online at:

MUNICH--(BUSINESS WIRE)-- Isarna Therapeutics will present an update from its ISTH0036 clinical development program and the ongoing BETTER Study at the EURETINA meeting in Hamburg, Germany on September 1st, 2022. Prof. Marion Munk, MD, PhD, FEBO, the CMO of Isarna Therapeutics and a renowned global retina specialist will provide initial positive safety results and efficacy signs from 18 patients treated in the study. To date, the trial has reported a good safety pro ISTH0036 with no drug-related adverse events and no signs of intraocular inflammation. Prof. Munk will discuss initial efficacy signals seen in patients at one month post first treatment. “Isarna values the opportunity to interact with other specialists in the field at the EURETINA conference and present the positive progress we have achieved in the BETTER trial,” commented Dr. Rene Rückert, MD, MBA, COO of Isarna Therapeutics. “We have now recruited a total of 23 out of the targeted 60 patients, with the trial on target to achieve full enrollment in the first quarter of 2023 and final data readout expected by the end of 2023.” The BETTER Study is an ongoing parallel, two-segment Phase 2 open label clinical study to evaluate Isarna’s lead candidate ISTH0036 in patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The study aims to enroll as many as 30 patients for each indication and is being conducted by internationally renowned experts at clinical trial centers in Austria and India. The study’s objective is to evaluate ISTH0036 in these two indications and gain data that will enable the transition into a Phase2b/3 clinical trial. The Phase 2 trial is gathering data on the reduction of retinal fluid and central macular thickness (CMT) as the primary endpoint and improvement of visual acuity (VA) as a secondary endpoint during a treatment period of seven months, followed by a two-month safety follow-up. The trial aims to explore the prevention of fibrosis and epithelial-mesenchymal transition as a key differentiator to currently approved anti-angiogenic therapies, mostly targeting Vascular Endothelial Growth Factors (VEGF). Furthermore, the durability of the antisense therapy ISTH0036 will be evaluated, which showed target suppression in preclinical models for more than four months. Patients selected for the trials will include both newly diagnosed, treatment naïve patients and those who have already been treated with anti-VEGF therapeutics. Wet AMD causes reduced vision in the center of the eye and affects as many as 190 million people globally1. Macular edema occurs when there is abnormal leakage and accumulation of fluid in the macula from damaged, dysfunctional blood vessels in the retina. A common cause of macular edema is diabetes, which is the leading cause of irreversible blindness in mature adults in the U.S.2 Both diseases can be treated with a range of anti-VEGF drugs however, these therapeutics are not able to maintain visual acuity as many patients develop fibrosis during the disease progression. Isarna has developed ISTH0036 to target the transforming growth factor-beta (TGF-β), a protein which is chronically elevated in ophthalmic, fibrotic, immunologic, and cancerous diseases. ISTH0036 suppresses TGF-β protein production via well-studied antisense mechanisms. *** About Isarna Isarna Therapeutics was built on profound knowledge in antisense oligonucleotide design and therapeutic development of this innovative compound class. Today, Isarna is developing a portfolio of antisense therapies targeting an emerging therapeutic field in human biology: TGF-β signaling. Precise modulation of TGF-β pathways using antisense therapy may result in safer and more effective treatment options for a broad range of indications. Currently, Isarna is focusing on ophthalmology; its lead compound, ISTH0036, has entered Phase 2 clinical development in the blockbuster indications wet AMD and DME. In addition, Isarna has established a portfolio of antisense compounds addressing three important isoforms of TGF-β to treat fibrotic liver disease, such as NASH, and various forms of cancer. 1 Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, et al. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013;1:e339–49. 2 Bressler NM. Age-related macular degeneration is the leading cause of blindness. JAMA. 2004 Apr 21;291(15):1900-1. doi: 10.1001/jama.291.15.1900. PMID: 15108691. View source version on businesswire.com: Contacts Contact Isarna Prof. Marion Munk, CMO info@isarna-therapeutics.com Media Inquiries Trophic Communications Gretchen Schweitzer or Desmond James Phone: +49 151 678 59086 isarna@trophic.de Source: Isarna Therapeutics View this news release online at:

Almost five months after emerging from stealth mode on a mission to leverage work being done in “flyover” states like Texas and Wisconsin, Sporos Bioventures has named its first official CEO. Amit Rakhit left his role as president and CMO of Ovid Therapeutics to take the helm at Sporos, a Houston-based upstart launched by Genzyme vet Michael Wyzga , ex- MD Anderson chief Ron DePinho , BridgeBio co-founder Peter Feinberg , Tvardi Therapeutics CSO Jeno Gyuris , and entrepreneur Alex Cranberg . As an “inquisitive and curious” kid, Rakhit was always playing with bugs and flowers, or looking for constellations. But it wasn’t until he was older that he decided to pursue a career in healthcare. After getting his bachelor’s degree in molecular biology from UC-Berkeley, he went straight into medical school at Tufts University. He followed that up with a residency in pediatrics at Tufts, a stint working with the Mother Teresa at an orphanage in Kolkata, India, and a fellowship in cardiology at Boston Children’s Hospital. Rakhit ended up on the staff at Boston Children’s for a while, but he eventually craved more. He began toying with the idea of a career in the biopharma industry, making drugs instead of prescribing them. “While as a physician you can take care of one person, which is very, very meaningful… but in the industry, what we get to do is affect millions of lives,” he told Endpoints News. In 2001, he took a job at Bristol Myers Squibb , where he worked on the blockbuster blood-thinning drug Plavix . “That’s where I learned the business,” he said, adding that he remained at BMS for almost 10 years, before that “inquisitiveness and curiosity” led him to Biogen . “I really wanted to be in a smaller company and see what that was like,” he said. Steve Holtzman recruited Rakhit to Biogen in 2011, where he joined the ALS team. After an unsuccessful Phase III readout, he pivoted over to the Spinraza team, which later became the first drug approved to treat spinal muscular atrophy (SMA). Rakhit recalled that during his residency, he treated a child with SMA who died without an available treatment. “(That) really brought it back home, why I got into medicine and why I went into industry,” he said. Rakhit continued working on neuro at Ovid, where he eventually worked his way up to CMO and president before leaving for Sporos in August. Sporos touts itself as an “innovation hub,” sporting four portfolio companies as well as a suite of in-house small molecule programs. The company nabbed $38.1 million in a Series A round back in May, and soon plans to kick off its own internal antibody engine, according to Rakhit, who said the upstart is experiencing a period of “explosive growth.” — Nicole DeFeudis → At the forefront of studying the blood-brain barrier, Denali raised the window on Hunter syndrome data in late July in which the South San Francisco biotech found positives — and analysts expressed concerns. Two months later, Katie Peng has been named chief commercial officer at Denali, even though none of its drugs are close to launch yet. Peng had been associated with Roche and Genentech for the past 16 years, taking charge of Genentech’s OMNI (ophthalmology, metabolism, neuroscience, immunology) business unit before leaping to Denali. Some analysts particularly soured on Denali’s muddled results for the neurofilament biomarker while giving themselves wiggle room to be swayed down the road. “Bottom line, these data are clearly not encouraging, but we don’t disagree with management that it may be too early to see anything as we don’t fully understand the kinetics of NfL changes, especially in a treatment setting,” wrote Stifel ’s Paul Matteis . → Michael Amoroso should pay rent in Peer Review as much as he’s been here in the last year. He turns up again this week by replacing Matt Kane starting Oct. 15 as president and CEO of Durham, NC-based Precision BioSciences , which got a shot in the arm from Jim Wilson back in February when he used Precision’s ARCUS gene editing platform for his PCSK9 study. We documented Amoroso’s meteoric ascent through the ranks at Abeona in last week’s edition when he was named chairman and then passed the CEO torch to Vishwas Seshadri . Before joining Abeona, Amoroso was Kite ’s chief commercial officer, and earlier he was SVP, Americas commercial, oncology business group at Eisai . → With its RARα agonist tamibarotene in a Phase II acute myeloid leukemia trial in combination with venetoclax and azacitidine , Syros has looked to Novartis for its first CCO. Conley Chee has spent the last 15 years at the pharma giant, concluding his tenure as global head of portfolio management, global pipeline strategy and precision medicine. Chee’s Big Pharma background doesn’t stop there: He’s also been Pfizer ’s team leader of international business development. During last year’s ASH conference, Bain Capital pumped in more than $90 million of financing as Syros charges ahead with a pipeline that’s also comprised of SY-2101 and oral CDK7 inhibitor SY-5609 . → Molly Harper is moving on after just a year as EVP of operations at Relmada Therapeutics , grabbing a C-suite gig as CBO of Cambridge, MA synbio player and Ginkgo collaborator Synlogic . We covered Harper’s jump to Relmada in May 2020 from Akcea , where she was SVP and global franchise general manager, and at Sanofi Genzyme she led US endocrinology in the rare disease division. In recent months she’s also tallied board seats at PreciseDx and Catalyst Pharmaceuticals . → In this week’s first example of top talent at Alexion packing their bags after the AstraZeneca takeover , UK-based iron deficiency biotech Shield Therapeutics has welcomed Sanofi Genzyme vet Jose Menoyo as CMO. Menoyo has experience with companies that AstraZeneca fancies, recently leading US medical affairs at Alexion and serving as SVP of medical affairs at ZS Pharma , which AstraZeneca acquired in 2015. Toward the end of his time at Sanofi, Menoyo was VP, renal global medical affairs and division medical officer, specialty care division. → Also putting the “ex” in Alexion, Lori Escobedo has been named chief people officer of biomolecular condensate specialist Dewpoint Therapeutics , one of this year’s Endpoints 11 honorees . Escobedo filled the VP of HR role supporting R&D, medical affairs, and legal functions at Alexion, and for 12 years before that, she was in HR leadership at Sandoz and Novartis. CSO Isaac Levin and SVP of chemistry and drug discovery Michael Wagner are other execs who have joined Dewpoint since Ameet Nathwani took the top spot almost one year ago. → Wrapping up this little sub-section, Karen-Leigh Edwards has bought her ticket out of Alexion as well, signing on to Bedford, MA-based eye disease biotech Ocular Therapeutix as SVP of technical operations. Edwards spent five years at Alexion, eventually leading external manufacturing and operations before this opportunity came into view. Edwards became associate director, global supply chain during the second of her two tenures with Biogen. → Bayer has turned to Nicole Hayes to be director of US external communications after nearly three years with The Bountiful Company , whose core brands like Nature’s Bounty and Ester-C are now under the control of Nestlé Health Science in a $5.75 billion acquisition. Hayes has also led external communications at Toys “R” Us . → German antisense oligonucleotide biotech Isarna Therapeutics has tapped Claus Schalper as CEO. Schalper tries his hand at leading another company after co-founding Pieris , where he was also CFO, and co-founding and handling CEO duties at XL-protein GmbH . Putting its eggs in the ophthalmology basket for now, Isarna’s lead candidate ISTH0036 will imminently start Phase IIa trials for AMD and DME. → Radiopharma is all the rage with ITM , Aktis and RayzeBio gathering up some serious coin in the space this year — and Fusion Pharmaceuticals is in the middle of the action too, appointing Mohit Rawat president and CBO. Rawat hails from Novartis Oncology , where he was VP and global disease lead for the chronic myeloid leukemia (CML) franchise and at one time was the marketing director for Cosentyx . Incidentally, Novartis has made another stride in with its radiopharma ambition with a breakthrough therapy designation for 177 Lu-PSMA-617, a product of its 2018 acquisition of Endocyte . → New York-based cancer metastasis biotech HiberCell has brought on Jonathan Lanfear to be the new COO, coming shortly after HiberCell bought out Genuity Science in August with its genomics tools and AI platform. Lanfear, a Pfizer alum in business development, joins HiberCell after leaving Takeda last year, finishing his nine years there as the global head of business R&D. → Lise Lund Kjems has joined Gainesville, FL-based Cyclo Therapeutics as CMO. Kjems spent nearly a decade at Novartis before most recently serving as VP, head of clinical development at Albireo . At Cyclo, she replaces acting CMO Gerald Cox , who now shifts to the company’s scientific advisory board. → With BARDA’s financial assistance, Sioux Falls-based SAB Biotherapeutics is on the march to Phase III with SAB-185 , its intravenous polyclonal antibody treatment for Covid-19, and has welcomed Big Pharma vet Russell Beyer as CFO. Starting well before the 1999 merger, Beyer was AstraZeneca’s CFO for Puerto Rico and Mexico, and he’s recently been senior director of finance at Teva for seven years. At the beginning of the summer, SAB announced it would merge with Big Cypress Acquisition Corp. in a $325 million SPAC deal. → Getting its house in order commercially for BTK inhibitor tirabrutinib , Ono Pharmaceutical ’s US sub Ono Pharma USA has recruited David Trexler as CCO. Recently the president and a board member at MorphoSys — which snapped up Constellation Pharmaceuticals for $1.7 billion a few months back — Trexler was the global brand lead for Bavencio and the SVP, US oncology commercial for EMD Serono . He also logged 10 years at Eisai in various business and marketing positions. → Chun-Pyn Shen has made his way over to Impact Therapeutics , where he’s taking on the role of head of regulatory affairs (VP). Shen hops aboard the Shanghai-based company from DymaniCure Biotechnology , where he served as VP, global project head. Shen jumpstarted his career at Merck and spent a decade with the company before heading over to Adaptimmune to served as director, clinical research and development and later on Questcor / Mallinckrodt . Additionally, during his time at Merck KGaA, Shen made significant contributions to the approval of Bavencio. → Striking a huge deal with Boehringer Ingelheim earlier this month — up to $710 million in milestones — to allow the German pharma to gain entry into its antibody “library of libraries,” Emily Leproust ’s DNA manufacturing squad at Twist Bioscience has turned to Dennis Cho as SVP, general counsel and chief ethics and compliance officer. Cho leaves CytomX after only eight months as assistant general counsel and has also brought his legal expertise to Seagen and, for nine years, Celgene . → Brii Bio celebrated its $320 million arrival on the Hong Kong stock exchange with comeback data in the NIH-backed trial for its Covid-19 antibody combo last month. Zhi Hong -led Brii also has a new exec on board with Coy Stout taking the role of SVP and head of US market access and patient advocacy. Thus ends a 17-year relationship Stout had in several capacities with Gilead that drew to a close as VP of US commercial access and reimbursement. → Vaxart just revealed that James Cummings has taken over as CMO this month. Cummings was previously president of Icon ’s federal business unit, Icon GPHS , and VP of clinical development and translational medicine at Novavax . It’s a pivotal hire for Andrei Floroiu ’s bunch at the South San Francisco vaccine biotech as Phase II trials get underway for its oral tablet Covid-19 vaccine. → Swiss uterine fibroid biotech ObsEva has named Luigi Marro as its new chief transformation officer effective today. An alum of Finox Biotech as CFO and Merck Serono in global strategy, Marro is added to the leadership roster after Merck spinout Organon inked a $500 million deal in July for worldwide rights to ObsEva’s preterm labor treatment ebopiprant . → After Avinash Desai earned a promotion to CMO of Actinium , his predecessor Mark Berger is taking the same job in the Lone Star State at Austin-based gene therapy outfit Genprex . Prior to his time at Actinium, Berger was SVP of clinical research at Kadmon and the CMO at Deciphera Pharmaceuticals . The C-suite at Genprex also grows with Hemant Kumar , a Big Pharma vet who settles into the new position of chief manufacturing and technology officer. Kumar’s been involved in manufacturing and technical operations with heavy hitters like Merck , Lonza and Janssen , and he heads to Genprex after a stint as VP, global head of manufacturing, supply chain, and strategy at Arcturus . → The Center for Breakthrough Medicines has tapped Peter Carbone as its COO. Carbone hails from Accorda Therapeutics , where he most recently served as EVP, quality. In addition to his stint at Accorda, Carbone joins with experience from his times at Novartis, Bayer and Amgen . → Nanocan Therapeutics has brought on Elizabeth Charlotte Moser as CSO. Moser joins the Princeton, NJ-based company from Galera Therapeutics , where she was VP for clinical development. Prior to that, she held positions at Elekta and Champalimaud Foundation . → Rob Rode takes over the CCO position at Apnimed as the company expands its leadership following such appointments as CFO Michael Rogers and SVP of medical affairs David White . Before joining Apnimed, which focuses on developing treatments for sleep apnea, Rode served as VP of commercial operations for cardiovascular and metabolic diseases at Merck. → Prime Therapeutics has reeled in Chris Knibb to be its new CFO, taking over for Dave Schlett, who is transitioning to the role of EVP, chief client relationship and administrative officer. Knibb most recently served as CFO at SOC Telemed and previously served as Express Scripts’ SVP of finance and chief accounting officer. → Sandwiched in between The Ohio State University and the famed Jack Nicklaus-designed Muirfield Village Golf Club in Dublin, immunodiagnostic and immunotherapy biotech Navidea Biopharmaceuticals has tapped Michel Mikhail as chief regulatory officer. Mikhail has been a regulatory exec for a variety of companies, including BioNTech , Fresenius Kabi , GlaxoSmithKline when it was SmithKline Beecham , and Boehringer Ingelheim. → Barbara Regonini has taken on the newly created post of finance director at Milan-based hematopoietic stem cell gene therapy biotech Genenta Science , which is in Phase I/II with Temferon for patients with glioblastoma multiforme. Regonini, formerly a senior manager at PwC, was recently CFO at OAM, an Italian financial brokerage company. Elsewhere at Genenta, Brad Loncar — an invaluable Endpoints resource — is on board as a strategic advisor, along with Alec Ross and Rocket Pharmaceuticals CEO Gaurav Shah . → Backed by MPM and OrbiMed , ReCode Therapeutics has been methodically assembling its leadership since taking the wraps off its lipid nanoparticle (LNP) delivery platform to the tune of an $80 million Series A in March 2020. ReCode now brings in Nick France as SVP of clinical development after two years as Escape Bio ’s head of clinical research. At Roivant and Axovant , France was senior director, clinical development for neurosciences and rare diseases, and he’s also held clinical development posts at Strongbridge Biopharma , CSL Behring and GSK. → Craig Masse has been promoted to SVP of discovery research at Ajax Therapeutics out of New York, co-founded by partner Schrödinger and taking aim at hematologic malignancies using computational chemistry. Masse, who first joined Ajax in 2019, was the head of medicinal chemistry during his eight-year run at Nimbus . Furthermore, Ajax has brought on Christina Riordan as VP of preclinical development. Riordan brings a wealth of experience in toxicology from Biogen, Epizyme , Agenus , Surface Oncology and until her move to Ajax, Certara . → The Italian venture capital firm Panakès Partners has named Rob Woodman as partner, leading the firm’s newly created biotech investment team. Most recently, Woodman served as senior partner at Takeda Ventures . Panakès entered the biotech sector back in July with its $180 million fund to support “underserved” life sciences companies in Europe. → Right on the heels of an $11.5 billion acquisition of Acceleron , Merck has promoted Thomas Glocer to independent lead director. A member of Merck’s board of directors since 2007, he comes from the finance world as the current lead director of Morgan Stanley . → EQRx has appointed Kathy Giusti to its board of directors. Giusti, who founded and serves as chief mission officer at the Multiple Myeloma Research Foundation, also founded the Harvard Business School Kraft Precision Medicine Accelerator. Looking to shake up drug pricing, EQRx reverse merged with the CM Life Sciences III SPAC back in August, netting the new biotech $1.8 billion, while appointing Melanie Nallicheri as CEO. She takes over from Alexis Borisy , who becomes the executive chairman of EQRx’s board of directors. → Incyte doubled its fun last week with FDA approvals of ruxolitinib for atopic dermatitis and chronic graft-versus-host disease , and Otis Brawley now joins Incyte’s board of directors. Brawley, the chief medical and scientific officer of the American Cancer Society from 2007-18, is the Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins. → GSK neuro partner Alector has given ex-Novartis SVP global head of clinical development Elizabeth Garofalo a seat on the board of directors alongside Tillman Gerngross and Terry McGuire , among others. The principal for EAG Pharma Consulting , Garofalo is a board member at Xenon Pharmaceuticals , Exicure and Acadia Pharmaceuticals . → Newly retired from AstraZeneca, Ann Taylor has signed on to the board of directors at Terns Pharmaceuticals , which has reasons for optimism with its June data in a thorny NASH field. Taylor was head of clinical biologics at AstraZeneca sub MedImmune before becoming CMO at AstraZeneca in April 2019. → Andrew Allen has joined the board of directors at Verge Genomics , Alice Zhang ’s AI-driven upstart that’s teaming up with Eli Lilly in the neuro space, particularly ALS. Allen, who co-founded and is president and CEO of Gritstone Bio , is also on the boards of Epizyme, TCR² Therapeutics and Sierra Oncology . → Ran Zheng has taken a seat on the board of directors at Jennifer Doudna ‘s CRISPR genome editing upstart Caribou Biosciences. The current CEO of Landmark Bio is a longtime Amgen vet who was also chief technical officer of Orchard Therapeutics . → New York-based Phosplatin Therapeutics has enlisted Elizabeth Tallett to its board of directors. This isn’t Tallett’s first board appointment. Currently, she has seats on the boards of Moderna , Anthem and Qiagen . Tallett was the former president and CEO of Transcell Technologies and a principal at Hunter Partners . Prior to those roles, Tallett was president of Centocor Pharmaceuticals . → Oxford “dark antigen” startup Enara Bio — in a partnership with Boehringer Ingelheim to develop therapies that target lung and GI cancers — has added Robert Ang to the board of directors. Since 2019, Ang has been president and CEO of Vor Biopharma . → MAIA Biotechnology has appointed Steven Chaouki to its board of directors. Chaouki currently served as president, US markets & consumer interactive of TransUnion and previously served as EVP, financial services for the company. Derek Graf and Paul Schloesser contributed to this edition.