Biotech Company Seeks FDA Approval For Psilocybin-IBS Treatment

Tryp Therapeutics announced on Wednesday that it had “submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its planned Phase 2a clinical trial investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS) at Massachusetts General Hospital (MGH).”

The Canadian company said in the announcement that the “planned open label study in collaboration with Harvard Medical School/Massachusetts General Hospital will evaluate the effect of psilocybin-assisted psychotherapy in patients with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms.” 

“Many of these patients also suffer from fibromyalgia, anxiety and fatigue. The primary efficacy endpoint of the study will be improvement in abdominal pain. The proposed study will also explore changes in brain connectivity and responses to pain at baseline and at four weeks, six months and twelve months post the psychedelic drug sessions, along with numerous other secondary endpoints,” the announcement said. 

“Tryp and our collaborators at Harvard/MGH believe there is tremendous potential for the treatment of debilitating IBS symptoms by utilizing the combined administration of psilocybin and psychotherapy. The clinical study will examine how psilocybin-assisted psychotherapy may alter brain networks involved in chronic abdominal pain and gastrointestinal-specific anxiety in patients with IBS to improve their symptoms. Submission of IND 163994 is an important step in advancing our program,” said Jim Gilligan, the chief executive officer of Tryp Therapeutics.

Gilligan told Green Market Report that the “most important thing is a clinical data – to be able to not just assume or hypothesize that we’re going to have a benefit, but to actually demonstrate that we can do something positive for patients.

“We’re looking at things a little bit differently than the big guys, looking at unique areas where we can have first-mover advantage. But we’re judicious in selecting areas where we really think that we’ll have a positive outcome,” Gilligan said.

According to Green Market Report, Gilligan “likened the planned administration of psilocin to the work of anesthesiologists.”

“Using an IV to induce and subsequently awaken the patient from the psychedelic state, the approach might also allow for the use of serotonin antagonists to terminate the psychedelic experience, if necessary,” the outlet said, which noted that TRP-8803 will be “central” to the company’s approach to the therapy.

TRP-8803 is “Tryp’s lead program,” the company says, describing it as “a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe.

“The Company has an ongoing Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, an upcoming Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia and a planned Phase 2a trial for the treatment of irritable bowel syndrome at Mass General Hospital, all of which are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. Where a preliminary clinical benefit has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin) which has the potential to further improve efficacy, safety and patient experience,” Tryp said in Wednesday’s announcement. 

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New Study Finds Cannabis A Safe, Effective Treatment For Cancer Pain

A new study led by a team of Irish, American and Canadian researchers has determined that medical cannabis is a safe and effective treatment for pain caused by cancer when combined with other drugs. The researchers, who are affiliated with the Royal College of Surgeons, Dublin, and the Medical Cannabis Programme in Oncology at Cedars Cancer Centre in Canada, McGill University and Harvard Medical School, concluded that medicinal cannabis is “a safe and effective complementary treatment for pain relief in patients with cancer.”

The study, which was published this week by the peer-reviewed journal BMJ Supportive & Palliative Care, sought to investigate the effectiveness of medical cannabis in reducing pain in cancer patients. The research also examined the effectiveness of medical cannabis in reducing the use of other medications in patients with cancer.

“Our data suggest a role for medicinal cannabis as a safe and complementary treatment option in patients with cancer failing to reach adequate pain relief through conventional analgesics, such as opioids,” the authors of the study wrote.

In their introduction, the researchers note that approximately 38% of cancer patients experience moderate to severe pain. The rate is even higher for some groups of patients, with 55% of patients undergoing anticancer treatment and 66% of patients with advanced, metastatic or terminal disease experiencing pain. Painkillers, often powerful opioids, are the standard treatment for cancer pain, but about a third of patients who use the drugs still experience pain.

To conduct the study, the research team surveyed 358 adult cancer patients over a period of three years to collect real-world data on cancer pain and its treatment. The average age of participants in the study group was 57, and 48% of patients were men. The most common cancer diagnoses were genitourinary, breast and bowel cancers.

About a quarter of the patients were given medical cannabis products rich in THC, 17% were given CBD-dominant formulations and 38% were given a balanced mix of the two products.  Every three months for a period of one year, study participants were surveyed and asked how much pain they were experiencing. Patients were also asked how many drugs they took to treat the pain.

Medical Cannabis Reduced Cancer Pain

At three, six and nine months into the study, patients experienced a significant reduction in pain, as measured by factors including pain severity, average pain intensity and overall interference with day-to-day life. Additionally, the research revealed that medical cannabis formulations with a balanced mix of THC and CBD were most effective at reducing the pain experienced by patients during the study.

The researchers also observed a reduction in the number of medications taken by participants during the study period and concluded that medical cannabis was a safe and effective complementary option for patients. 

“The particularly good safety profile of [medicinal cannabis] found in this study can be partly attributed to the close supervision by healthcare professionals who authorized, directed, and monitored [the] treatment,” the researchers wrote.

Overall, the medical cannabis products were well tolerated by the patients in the study group. The most commonly reported side effects of the medical cannabis treatments were fatigue and sleepiness, but only by two and three patients, respectively.

The team of researchers recommended further study into using cannabis as a treatment for pain caused by cancer, writing that their “findings should be confirmed through randomized placebo-controlled trials.” They also recommended continued research “particularly to understand any benefits and risks of these medicines for children and young people.”

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Harvard Grad Student Dies in Bali From Police Brutality Over Cannabis Arrest

Rodrigo Ventocilla Ventosilla, 32, a Harvard Kennedy School (HKS) graduate student from Peru, died on August 11 while under police custody at a hospital in Denpasar, Indonesia under what the family calls suspicious circumstances. Ventosilla, a trans man, was arrested for possession of cannabis while traveling to Bali to celebrate his honeymoon.

The HKS and trans communities are pleading for help in highlighting the injustice and human rights violations that allegedly took place last month in Bali, with allegations of police brutality and torture.

Police took Ventocilla to Bhayangkara Hospital after he suffered stomach pain and vomiting, according to Radar Bali. But his condition deteriorated, and he was transported to the Sanglah Central General Hospital, where he was pronounced dead on August 11 at around 3:10 p.m.

HKS Dean Douglas Elmendorf and HKS Senior Associate Dean for Degree Programs and Student Affairs ​​Debra E. “Debbie” Isaacson announced Ventocilla’s death to school associates and friends on August 12. 

Witnesses allege that it was a case of police brutality, and say that the police’s official story is baloney. They are demanding an independent investigation of what happened in Bali. Stefanus Satake Bayu Setianto, head of public relations for the Bali Police, claims Ventocilla consumed more unseized drugs on August 8 in jail which led to his death.

A statement from the families of Ventocilla and his spouse, Sebastián Marallano, asked for the “Peruvian justice system to properly investigate the human rights violations of Rodrigo and Sebastian and to guarantee truth, justice, and reparation.”

Marallano flew to Bali on a separate flight but was detained by police without charge after attempting to help Ventocilla, according to the family’s statement. Marallano—who had nothing to do with the cannabis charges—was also “hospitalized” days after being detained by police.

“We received yesterday a statement from Rodrigo’s family with their description of extremely disturbing circumstances surrounding Rodrigo’s death—a statement that talks about his arrest and detention just before his death, and that highlights his rights as a transgender man,” Elmendorf wrote in an August 24 statement.

“The statement from Rodrigo’s family raises very serious questions that deserve clear and accurate answers. Harvard Kennedy School supports the family’s call for an immediate and thorough investigation and for public release of all relevant information, and the School stands with all of Rodrigo’s friends and colleagues and with the LGBTQ+ community.”

Ventocilla was a co-founder of the Peruvian trans rights advocacy organization Diversidades Trans Masculinas. At the Harvard Kennedy School, he was pursuing a master’s degree in Public Administration in International Development.

The family is asking the Peruvian Foreign Ministry to conduct an investigation into the actions of Julio Eduardo Tenorio Pereyra, the head of consular services for the Peruvian Embassy in Indonesia.

It’s just the latest cannabis-related crime in Bali in which the punishments don’t seem to fit the crime by Western standards. A Brazilian student faced 15 years after he was caught at the Ngurah Rai International Airport in Bali with 9.1 grams of cannabis.

Elmendorf and Isaacson said that HKS will hold a memorial gathering in memory of Ventocilla.

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When Harvard Professors Took Psychedelics With Their Own Students

In the popular Netflix documentary series How to Change Your Mind, host Michael Pollan briefly touches on the academic ecosystem in which psychedelic drugs were studied after LSD was synthesized in Switzerland. A much, much closer look at this ecosystem can be found in a new book titled Harvard’s Quixotic Pursuit of a New Science, written by the Washington-based attorney Patrick L. Schmidt.

Schmidt’s book, which evolved from an undergraduate thesis project, traces the convoluted but surprisingly dramatic history of the Department of Social Relations, a decades-long attempt by some of Harvard’s most forward-thinking faculty members to combine the rising disciplines of sociology, cultural anthropology, and personality psychology into a single program.

The Department of Social Relations was established in 1946 in response to the Second World War, which raised questions about human nature and man’s place in society that older, more authoritative disciplines such as history, economics and government failed to answer. Although the department no longer exists, it made valuable contributions to the college and country alike.

For instance, at the start of the Cold War, the American government asked Social Relations faculty to study Soviet citizens and social institutions to figure out how the country would respond to coordinated attacks from the U.S. army. To the Pentagon’s dismay, researchers concluded the USSR was built on strong foundations that would take decades to corrode.

The most infamous chapter in Schmidt’s history takes place during the 1960s, the decade Social Relations—always on the lookout for out-of-the-box thinkers—hired Timothy Leary and Richard Alpert. Before Leary took to wearing his signature Nehru-collared shirts and love-beads, he was a self-described “caricature of a professor,” sporting a tweed-jacket with those unsightly leather elbow patches. 

Leary had been brought to Harvard by David McClelland, director of Social Relations’ Center for Research in Personality. McClelland was impressed by Leary’s book Interpersonal Diagnosis of Personality: A Functional Theory and Methodology for Personality Evaluation and hoped he would elevate psychology at Harvard. Leary did, though not—as Schmidt writes—“in the way McClelland had imagined.”

Leary alarmed his colleagues long before he began experimenting with psychedelic drugs. While teaching an advanced graduate seminar on the theory and practice of psychotherapy, he encouraged students to conduct fieldwork not at hospitals and clinics, but community centers, orphanages, jails, and other places where people lacked access to the psychiatric care they so desperately needed.

Leary became interested in psychedelics after taking magic mushrooms on a visit to Mexico in 1960. When Sandoz synthesized psilocybin a few years later, he requested a sample for research purposes. To Leary’s delight, the pharmaceutical company provided him with a giant bottle of pills. Attached to the package was a note: “Here’s a starter kit to get going and please send us a report of the results.”

Even in the progressive Department of Social Relations, Leary struggled to find colleagues willing to follow him down this road. Fortunately, he found a friend in Alpert, an assistant professor of clinical psychology and education. Schmidt says the two became friends because they were the only bachelors in the department, and the only teachers to offer office hours at night.

Together, Leary and Alpert set up three experiments. In the first, also known as the Harvard Psilocybin Project, graduate students from Harvard and other schools in Boston were given psilocybin and asked to write a report about their trips. In the second experiment, they offered psilocybin to prison inmates in the hope it would diminish recidivism.

In the third and final experiment, which eventually became known as the Good Friday Experiment, Leary and Alpert gave psilocybin to divinity students at the Andover Newton Theological School to see if it would cause them to have religious experiences. (Leary himself described his introduction to magic mushrooms in Mexico as “religious” in nature and wondered if others would do the same.)

The experiments made Leary and Alpert popular with students and unpopular with Harvard’s administrators—both for the same reason. Insisting that psilocybin should be taken in a non-clinical setting, sessions were held in people’s homes and apartments rather than in labs. This way, as the Harvard Psilocybin Project progressed, “it became less experimental, acquiring a partylike atmosphere.”

News about the experiment-parties spread quickly. Their inhibitions removed, ecstatic students phoned their parents to share fragments of their beautiful but admittedly concerning visions. Disapproving scholars promoted reports that experiments devolved into “mystical orgies” and that Alpert exchanged drugs with undergraduate men “in exchange for sexual favors.”

The professors were allowed to continue their experiments under the condition that they stop involving undergraduate students. This may have been for the better considering the average undergrad was more interested in consuming drugs than researching them. Also, two young students had been sent to mental institutions after taking psychedelics.

Not every test subject was enthusiastic about their trip. “There’s no wisdom there,” one student recorded. “I solved the secret of the universe last night, but this morning I forgot what it was.” The American novelist John Kerouac, an acquaintance of Leary’s, reached a similar verdict: “Got high but had funny hangover of brainwashed emptiness…Me take no more.”

Leary and Alpert protested Harvard’s interference in their work. While undergraduate students were less bookish than their graduate counterparts, they were also more enthusiastic and open-minded. Now that they were barred from the experiments, they would try to obtain and consume psychedelics without the supervision of responsible adults.

The students who went mad from their trips deserve sympathy and the student who did not find his trip academically valuable makes a fair point. Statistically, however, they were the exception rather than the norm. Undeterred—indeed motivated—by Richard Nixon’s condemnations, drug use at Harvard developed into a supportive, welcoming, and generally good-natured culture.

“Drugs were becoming ultra-trendy,” Leary recalled. “Every weekend the Harvard resident houses were transformed into spaceships floating miles above the Yard … For the most part the drug epidemic Cambridge seemed benign. Hundreds of Harvard students expanded their minds, had visions, read mystical literature, and wrote intelligent essays about their experiences. It seemed to us they were benefitting.”

Benefitting or not, the psilocybin experiments soon came to end altogether. In 1963, Leary’s contract with Harvard was terminated for failing to attend his own lectures, though Leary contested this claim and suspected it was nothing more than an easy excuse to show him the door. Later that year Harvard refused to renew Alpert’s contract, sending him off as well.

Despite its brief lifespan, the Harvard Psychedelic Project could have only occurred at Harvard, inside the Department of Social Relations. The tolerance for and—more importantly—interest in Leary and Alpert’s research was the result of a larger battle being waged at the university between tenured professors who wanted to preserve academic tradition and newcomers who wanted to develop new ways of thinking.

Like the Harvard Psychedelic Project, the Department of Social Relations itself was eventually terminated by Harvard faculty. Yet while Social Relations is largely forgotten, the legacies of Leary and Alpert live on. With cultural norms shifting, the academic world is once again studying the effects and benefits of psychedelics. Every study published today is in some way connected to the Project. 

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Children with cancer and their misunderstood endocannabinoid system

Conventional cancer treatments, especially radio and chemotherapy are harsh on the body. But for children, conventional treatments can become unbearable. Hidden by prohibition is how the endocannabinoid system (ECS) behaves in children with cancer. Childhood and the ECS are sadly two subjects rarely explored in unison. Adolescent cancer is indeed a rare disease despite being […]

The post Children with cancer and their misunderstood endocannabinoid system appeared first on Cannabis News, Lifestyle – Headlines, Videos & Cooking.

Harvard Researchers to Explore Cannabis as Medicine for Poorer Nations

A new collaborative institute aims to study cannabis as part of its mission to increase access to evidence-based plant medicine in poor and developing nations.

The International Phytomedicines Institute (IPI) at Harvard Medical School, was launched on May 26 during the 2019 Global Health Catalyst summit at Harvard Medical School, an annual conference focused primarily on reducing disparities to access to healthcare. Phytomedicine is a plant-based medicinal practice that utilizes plant materials for preventive and therapeutic purposes

Cannabis is one of the primary plants the IPI will begin studying. 

The IPI aims to apply the wealth of science and technology at Harvard and strategically partner it with other educational institutions and private industry to convert potential high-impact medicinal plants “to evidence-based pharmaceutical grade products for global health and economic development.”

Leading the effort is Professor Wil Ngwa, who is director of the Global Health Catalyst at Brigham and Women’s Hospital and Dana-Farber Cancer Institute, both affiliated with Harvard Medical School. Ngwa sees the collaborations as a key to providing focused and detailed research into the medicinal qualities of the cannabis plant.

“You need the critical mass of people coming together, and I think that Harvard provides that platform,” he said.

Seed funding for the initiative was provided by the Brigham and Women’s Hospital and Dana-Farber Cancer Institute, and it includes funding support and sponsored research agreements with industry partners.

While initial commitments from the launch already have reached $6 million, more funds are expected from ongoing partnership discussions, according to Lydia Asana, Ph.D., coordinator for the Harvard Global Health Catalyst Summit. So far, the focus of the Global Health Catalyst has been research into cancer and non-communicable diseases, but in the last few years researchers at the center developed an interest in pain management, Asana said.

“That led to our initial dabbling with cannabinoids and their potential to be used to manage pain,” she said. “It just seemed like things were coming together and it was a great time to explore this.”

Access to pain medications is severely limited in poor and developing countries. For example, of the 329 tons of morphine-equivalent opioids distributed worldwide per year, roughly 22 pounds went to low-income countries, according to a report from the International Narcotics Control Board (INCB), which looked the average global distribution between 2010 and 2013. The INCB found in a 2015 report that 75% of the world population has no access to proper pain relief medicines. 

A study in 2017 by the Lancet Commission on Pollution and Health showed that more than 25.5 million people who died in 2015 experienced serious health-related suffering. Of those, more than 80% of the people who died with serious illnesses that year were from developing regions — and the vast majority lacked access to palliative care and pain relief. Each year, nearly 2.5 million children die with serious health-related suffering, 98% of whom are from developing regions, according to the Lancet report.

“This is a major problem in African countries and Southeast Asian countries,” Asana said.

Ngwa, who used the term “farm to bedside” to describe the breadth of their planned research, said the institute will begin looking at crops with the goal of clearing up the reams of existing, but confusing and conflicting, scientific information on cannabis.

“One of the things that we think is the problem is that each cannabis product, whether it’s grown in California or it’s grown in Massachusetts, is not the same,” Ngwa said.

Ngwa said the institute will operate in a Drug Enforcement Agency (DEA)-approved facility at the Harvard Institutes of Medicine and other Harvard facilities to provide quality assurance to their industry partners. They’ll also begin studying the plant to develop uniform standards and applications.

“We provide high-quality, credible scientific analysis to identify what molecules are present and in what quantities, and can provide comparative analysis based on available data which would inform research conclusions, marketing, etc.,” he said.

The number of collaborators and industry partners represents an unprecedented level of collaboration at the Harvard-based institute.

IPI industry partners with either sponsored research agreements or commitments include Flavocure Biotech Inc.; Atlas Biotechnologies, and Cannabis Science Inc. Another partner is the Locker Room Consulting-Nestre-Primative (LNP) consortium.

Locker Room Consulting was founded by a group of professional athletes, including former National Football League (NFL) receiver Calvin Johnson, to help other former athletes in business and philanthropy.

The NFL and the NFL Players Association announced in May 2019 their plan to support additional resources for pain management in athletes, including alternative therapies such as cannabis.

Educational partners include the University of Pennsylvania, Oxford University in the United Kingdom, the University of Massachusetts, and the University of Heidelberg in Germany.

Though the institute just launched, and staffing and the focus of upcoming clinical trials are undetermined, Ngwa said he expects the institute to begin a clinical trial in 2020.  


Feature image: Plant medicine will be part of the focus of the International Phytomedicines Institute at Harvard Medical School, which was launched on May 26 during the 2019 Global Health Catalyst summit at Harvard Medical School. (Shutterstock)

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