Spectrum Pharmaceuticals announced detailed results from ADVANCE, a Phase 3 trial of Rolontis, demonstrating that it was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia in all four cycles of the study. Rolontis is a novel long-acting granulocyte colony-stimulating factor being studied as a treatment for neutropenia in patients undergoing myelosuppressive cytotoxic chemotherapy. The data released in an abstract as part of the American Society of Clinical Oncology, or ASCO, 2018 Annual Meeting, also showed similar safety profiles between the treatment groups.
Thursday, May 17, 2018
GW publishes phase 3 data on marijuana med for epilepsy
GW Pharmaceuticals, along with its U.S. subsidiary Greenwich Biosciences, announced that The New England Journal of Medicine has published results from a Phase 3 study of Epidiolex in patients with Lennox-Gastaut syndrome, a rare, severe and difficult to treat form of childhood-onset epilepsy. Epidiolex is a pharmaceutical formulation of highly purified cannabidiol, a cannabinoid lacking the high associated with marijuana. In this study, both evaluated doses of Epidiolex significantly reduced the monthly frequency of drop seizures compared to placebo in highly treatment-resistant patients when added to existing treatment. “This publication in The New England Journal of Medicine marks the third time within a year that positive data for Epidiolex have been published by a top-tier, peer-reviewed journal, offering further evidence of the potential of Epidiolex as a new treatment option within the field of treatment-resistant, childhood-onset epilepsy,” said Justin Gover, GW’s Chief Executive Officer. “We are now in the latter stages of the FDA’s review of the Epidiolex New Drug Application and look forward to a decision from FDA in late June. If approved, we expect to make this important new medicine available to patients with LGS and Dravet syndrome in the second half of the year.”
Endocyte has positive Phase 2 prostate cancer data at ASCO
Endocyte announced that a poster with data from the Peter MacCallum Cancer Centre will be presented on Endocyte’s lead investigational therapy at the 2018 ASCO Annual Meeting on Saturday, June 2, 2018. Updated data from the phase 2 study of 177Lu-PSMA-617 as a potential treatment for metastatic castration-resistant prostate cancer, including data from an additional 20 patient expansion cohort, will be highlighted by the poster. “We are very pleased that we continue to see high rates of PSA response, even in heavily pre-treated patients,” said Mike Sherman, president and CEO of Endocyte. “In the 50 patients receiving 177Lu-PSMA-617, 62% had a greater than 50% reduction in their PSA levels. Further, 44% of patients had a PSA reduction of 80% or greater. We look forward to sharing more information on this phase 2 trial at ASCO.”
Nektar ASCO results should get positive view: Piper
Nektar 214+nivo response for melanoma not conclusive, says Piper Jaffray. Piper Jaffray analyst Tyler Van Buren keeps his Overweight rating and $125 price target on Nektar (NKTR) after the release of PIVOT ASCO abstract of NKTR 214+nivo (BMY). The analyst says that while the 1L melanoma response rate may be “slightly lower than some had hoped for”, the 1L RCC response rate were “nicely above” what has been seen with ipi+nivo treatment. Van Buren adds that while small in numbers, “3/4 responses in 1L bladder and 1/3 responses in triple negative breast cancer are encouraging.” The analyst believes that the stock may be down in the morning, but investors should not come to “rash conclusions”, as the ASCO presentation with more patients and detail is likely to be positive.
Wednesday, May 16, 2018
Florida’s medical marijuana program is attracting troubled doctors
Debbie Knight had battled painful arthritis for years and hoped medical marijuana could provide some relief.
So one day in February, the 57-year-old Elvis and Cher impersonator scoured the internet, looking for the best doctor who could grant her access to Florida’s new program.
Fort Lauderdale 420 Marijuana Doctors was the closest and the cheapest. The office was in a safe part of town. And it reassured her that the business appeared to be a legitimate franchise, with sister offices in Miami and Jacksonville.
“I figured it’s like a little McDonald’s cannabis chain,” Knight said.
Then she walked into the office in Plantation.
It smelled like dirty, sweaty shoes. Crumpled fast-food bags dotted the doctor’s exam room. Papers and other junk piled up on the desk.
A young assistant asked her to pay $200, instead of the $80 that Knight saw online.
“Right there, I was ready to walk out the door, and I should have,” Knight said.
Dr. Khaja Chisty called Knight into his office for her exam, which Knight said consisted of a few questions. As she left, Chisty said her name would be entered into the state’s registry of patients allowed to buy marijuana by the following day, Knight said. Instead, weeks passed without her being added to the system.
The first time Knight called to ask why, the assistant apologized. The second time, a week later, the telephone number was disconnected.
Knight didn’t know that 14 months earlier, Chisty had agreed to stoppracticing medicine in Colorado after that state’s medical board accused him of presigning and postdating prescriptions and violating other patient care standards.
He, like other medical professionals with tarnished licenses, are finding new life in Florida’s medical marijuana program.
A Tampa Bay Times examination of the 1,432 doctors in the program reveals Florida’s new marijuana initiative has turned into a magnet for physicians with troubled pasts.
The Times analyzed Department of Health data from April detailing medical board discipline, $100,000-plus malpractice cases and criminal incidents, then reviewed hundreds of doctors’ files.
In total, 262 of the doctors had some sort of blemish on their record, the Times analysis shows — nearly 1 in 5 of the doctors allowed to prescribe marijuana.
Marijuana doctors were 2.8 times as likely as other doctors to have been disciplined by the Board of Medicine, and 2.4 times as likely to have been charged with a crime. Altogether, 108 of them were responsible for $69.4 million in malpractice judgments and settlements, some for maiming or killing patients.
Some of the doctors have been fined, suspended or stripped of their licenses in other states. They’ve misdiagnosed conditions, falsified records and written prescriptions for people they never saw. They’ve been jailed for domestic violence. A few have sexually abused patients, including those as young as 14 and 16.
Experts and marijuana advocates said they were surprised by the findings. Several faulted Florida’s system for being too discouraging to good physicians.
“The whole structure is set up to make it very unattractive for your average, law-abiding physician to want to do this,” said Ben Pollara, a political consultant who is a prominent leader in Florida’s medical marijuana movement. “And so the result is you get a higher proportion of people who may not have as much respect for the laws of the land.”
Florida Rep. Katie Edwards-Walpole, D-Plantation, who was a co-sponsor of the state’s first medical marijuana legislation in 2014, said the results of the Times analysis made her “blood boil.”
She blamed the Florida Board of Medicine and state Department of Health for being too lenient, and said the law may need to be changed.
“Perhaps we need to go back and make sure that physicians that have these pending claims or have been adjudicated have a character fitness component,” she said. “This isn’t a right for physicians to be able to do this. This really is a privilege.”
Neither the health department or medical board commented directly on the Times’ analysis. But a statement from spokesman Devin Galetta touted the state’s backgrounding of physicians and called the overall process for qualifying doctors “robust” and “thorough.”
“Our top priority in administering any disciplinary action against a licensed practitioner is always patient safety,” he said.
Two years ago, voters approved a constitutional amendment to expand Florida’s marijuana program to include those suffering from cancer, epilepsy, glaucoma, HIV-AIDS, post traumatic stress, Parkinson’s disease and a host of other ailments.
All that’s required is a letter of recommendation from a physician. The physician adds a patient’s name to a state database, and the state issues a card that lets him or her receive medical cannabis from an approved dispensary.
Floridians are increasingly warming to the idea.
Approximately 100,576 people are registered in the state’s medical marijuana program, and experts expect those numbers to steadily increase.
The state has slashed the length of the course doctors must take from eight hours to two, and the price of joining the program has dropped from $995 to $250. Still, doctor enlistments have lagged.
Pollara says Florida requires doctors to include specific details in their marijuana recommendations — details that make the document look like a prescription.
Because prescribing medical marijuana is illegal under federal law, some physicians are reluctant to join out of fear of being prosecuted or blacklisted by hospitals and other medical centers, said Ron Watson, executive director of the Florida Society of Cannabis Physicians.
“Hospital systems and nursing homes and hospices, they don’t even want this on their property because they’re scared that they might lose all their Medicaid and Medicare reimbursements,” Watson said. “If the hospital in their little town says, ‘Whoops, sorry, no more hospital staff privileges,’ what are you going to do?”
The Times review shows that physicians with soiled histories are increasingly filling in the gap.
At least 45 doctors in the program were accused by the Department of Health of prescribing drugs without doing proper checks.
Dr. Richard Daniel Potts of Ormond Beach was fined $2,500 in 2015 after the department said that he admitted to leaving six presigned blank prescriptions with a secretary. “I was going out of town, and I thought it was commonplace, but I’ve come to find out it was a really bad idea,” he told the Times.
In 2007, New York prosecutors charged Dr. Robert Gregory Carlson of Land O’Lakes with writing thousands of prescriptions for human growth hormone and other drugs for patients he never saw. They said he was part of an interstate steroids ring funneling prescriptions to professional baseball players, football players, pro wrestlers and other celebrities. He ultimately pleaded guilty to insurance fraud, and Florida allowed him to keep his license. Carlson did not respond to requests for comment.
Dr. Jay D. Ellenby, a plastic surgeon, began a seven-year affair with a patient and prescribed her a mix of powerful antidepressants and anxiety medication without proper documentation, according to a health department administrative complaint. Florida’s medical board fined Ellenby $5,000 in 2005 and ordered extra training and 50 hours of community service. Two years ago, he retired from plastic surgery. Last year the 82-year-old became chairman of MediCannaVision Inc., a St. Petersburg subsidiary of a Nevada-based entertainment company aiming to establish medical marijuana healthcare centers throughout Florida, state corporate records show. In an interview, Ellenby denied the allegations. He said he has stepped down from MediCannaVision’s board.
Some doctors in the program have struggled with drug and alcohol problems.
Dr. Victor Maquera of Clay County agreed to a $2,000 fine after a health department complaint said he improperly prescribed himself phentermine and testosterone from November 2011 to May 2013. Maquera could not be reached for comment.
Dr. Naglaa Abdel-Al of Orlando was an Arizona anesthesiologist when she decided to walk away during a 2010 surgery. She was later found in a daze in a nearby bathroom, high on the sedative Diprivan, according to an Arizona Medical Board order. Abdel-Al lost her ability to practice in eight states. But after finishing a year-long treatment program, she was returned to full privileges in Florida.
Abdel-Al said she’s no longer seeing marijuana patients because she didn’t have a large enough client base.
Other doctors were accused of acting inappropriately toward female patients.
When Dr. Robert Fietsam of Wesley Chapel worked at the Manatee County jail in 2014, he told an inmate he “loved” her and asked her to invent a medical problem so he could see her, according to a health department complaint. Fietsam told the Times he had phone conversations with a female inmate but said he was giving her religious counseling and the conversations were not romantic.
In an extreme case, psychiatrists described Dr. Stanley Dratler in 1985 as a sadist and sex addict after complaints that he fondled six patients, including two teenage girls aged 14 and 16. After a three-year suspension, Dratler took a medical job with the Florida Department of Corrections.
Dratler told the Times he’s been sober for 32 years and now only does house calls for elderly clients. “I obtained my marijuana certification only so that I could offer it to my patients,” he said. “Currently, I have no patients that I have prescribed any marijuana products for.”
Allegations have already surfaced of patients being hampered by some doctors’ profiteering.
Some physicians are traveling up and down the state, showing up at makeshift clinics that open suddenly and close unexpectedly, said Pat Deluca, a medical marijuana advocate who is executive director of Compassionate Cannabis Clinic in Venice. He says these traveling doctors often disappear after collecting the cash, and can’t be reached for weeks.
He says his clinic takes in 10 to 15 new people monthly who say their initial marijuana physician disappeared.
“It’s like the Wild Wild West,” Deluca said. “With everyone doing his own thing.”
In Colorado, patients of Chisty — the physician at Fort Lauderdale 420 Marijuana Doctors — flooded online sites with allegations of absenteeism, poor customer service and unethical price manipulations. There he owned Happy Minds, a psychiatric practice in Thornton, 10 miles northeast of Denver.
The Colorado Medical Board subsequently accused Chisty of presigning and postdating prescriptions and then leaving the country for weeks, according to an order written by the board.
Last month, he admitted to writing prescriptions to patients without giving them full examinations and other “unprofessional conduct,” according to another board order in Colorado. His license is currently inactive.
Florida officials filed a disciplinary action against him last September, citing his case in Colorado. The Florida case is still ongoing.
Knight believes she was scammed and that the same may happen to others.
“Half the people are going to pay the $200. If they want the (card) they’re just going to pay it,” she said. “But they are not going to get anything.”
Chisty told the Times he didn’t remember Knight’s case but that he would not dispute her description of Fort Lauderdale 420’s offices. He said that sometimes patients didn’t get entered into the state registry because they never turned over their medical records. He said he would have to review Knight’s file in order to know what happened in her case.
Chisty insisted the prices and office upkeep were handled solely by the clinic’s owner, a California-based company called the Supreme Medical Group. He said he is just a contractor at the company’s Miami, Plantation, Orlando and Jacksonville locations. He also sees patients in Sunnyvale, CA.
Chisty said some complaints had been filed about him with the Department of Health, but added, “I think it’s a bit unfair to target me.”
He said rampant abuses are occurring. One Florida clinic where he previously worked regularly took patients’ money without entering their names into the registry, he said. At another clinic, the owners ordered the physicians to approve all patients for medical marijuana, regardless of whether their medical conditions qualified, Chisty said. He quit after one week.
“Everybody wants to blame the doctors because there’s no one else to blame here. But the bigger problem is those owners who are motivated by profits and nothing else,” he said.
Fort Lauderdale 420’s management did not respond to a request for comment. A man who answered the company’s phone Thursday denied the clinic was dirty, but would not give his full name.
Galetta, the health department spokesman, said Chisty asked for a formal hearing to contest the state’s effort to discipline him. A date for that hearing has not been set. “During this time, the department continues to engage in negotiations of settlement to determine whether we can reach a reasonable resolution,” Galetta said.
After the recent complaints, Chisty said he has stopped seeing all marijuana clients. He is planning to quit Florida’s program and reapply for his medical license in Colorado.
“I’m sick and tired of this,” he said “After seeing these complaints, I’m like, ‘Oh my God.’ It just doesn’t make any sense here.”
Bioverativ, Sangamo: FDA Accepts Plan for Gene-Edited Sickle Cell Therapy
Bioverativ Inc., a Sanofi company dedicated to transforming the lives of people with rare blood disorders, and Sangamo Therapeutics, Inc. (NASDAQ:SGMO) announced today that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for BIVV003, a gene-edited cell therapy candidate for the treatment of people with sickle cell disease. Bioverativ and Sangamo are developing BIVV003 as part of an exclusive worldwide collaboration to develop and commercialize gene-edited cell therapies for sickle cell disease and beta thalassemia.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180516005404/en/
“This acceptance marks the second IND for this gene-editing approach in less than a year, and the first for a gene-edited therapy in sickle cell disease,” said Ken Huttner, M.D. Ph.D., Vice President, Clinical Development at Bioverativ. “It represents our commitment to advancing cutting-edge science and offers hope to the many people who have been waiting generations for an effective way to treat sickle cell disease. We look forward to advancing the program into clinical trials.”
“Sickle cell disease is a lifelong blood disorder with serious, painful and debilitating complications, and patients deserve new, more effective treatment options,” said Ed Conner, M.D., Chief Medical Officer at Sangamo. “Gene-edited cell therapy has the potential to provide patients living with sickle cell disease a lifelong treatment with a single administration. We believe the precision, efficiency and specificity of zinc finger nuclease technology differentiate BIVV003 from other genomic therapies in development.”
BIVV003 is a non-viral approach utilizing zinc finger nuclease (ZFN) gene-editing technology. By modifying a short sequence of the BCL11A gene in a patient’s red blood cell precursors, sickle hemoglobin production is suppressed, and the production of fetal hemoglobin is reactivated to levels that may protect patients against the progression of their sickle cell disease.
This IND enables Bioverativ to initiate a Phase 1/2 clinical trial to assess the safety, tolerability, and efficacy of BIVV003 in adults with sickle cell disease, and Bioverativ expects to open several clinical sites across the United States this year. Currently, Sangamo is enrolling patients with transfusion-dependent beta thalassemia in a Phase 1/2 trial evaluating the safety, tolerability, and efficacy of ST-400, which uses the same gene-editing approach as BIVV003.
LifePlus Has 1st Non-Invasive Continous Blood Glucose Monitoring Wearable
LifePlus Inc. today announced that it has entered the multi-billion-dollar smart medical wearables category with the introduction of Lifeleaf – the world’s first non-invasive continuous blood glucose monitoring multi-sensor wearable device. In addition to blood glucose monitoring, the patent-pending multi-sensor device non-invasively monitors heart rate, blood pressure, respiration rate and oxygen saturation. LifeLeaf by LifePlus is the first of its kind to non-invasively monitor the top five physiological health indicators and is based on an open standards based-software stack that is also available to license. The company also announced that LifeLeaf is currently active in five trials around the world.
LifePlus is backed by Silicon Valley-based JLA Advisors with industry visionary, serial tech-entrepreneur and White House Innovation Fellow John Trobough serving as the Executive Chairman of the Board. The announcement was made today at the Medical Wearables Conference in Santa Clara, Calif., where Trobough will also be presenting more LifePlus details to conference attendees tomorrow, May 17 at 2:15 p.m. at the Biltmore Hotel.
“We have been in stealth mode and today we are thrilled to announce the introduction of LifeLeaf as part of the burgeoning medical wearables category,” said Trobough. “Managing diabetes and other chronic diseases requires early and timely detection, rapid intervention and high compliance. LifeLeaf exceeds those requirements with its patent-pending open standards-based software stack and cloud-based analytics. LifeLeaf is different from any other product and software technology available – it is truly unique and we are excited to make this multi-sensor capability available to companies and developers globally.”
LifeLeaf by LifePlus is a multi-sensor wearable smartwatch that continuously and non-invasively monitors and tracks major chronic health risks such as diabetes, cardiac arrhythmia, congestive heart failure, COPD, sleep apnea and hypertension. It is a cloud-based AI solution with a user-interface that is simple and easy to use, as well as a connected mobile app that provides cloud-based analytics with real-time notifications. The product is targeted at the multi-billion-dollar medical wearables market, with an emphasis on the self-monitoring blood glucose market. The LifeLeaf wearable will be available later this year.
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