AGRONOMED BIOLOGICS AWARDED CLINICAL REGISTRANT PERMIT!!
Just recently announced; the Pennsylvania Department of Health has chosen three companies to work with medical schools to grow and research marijuana. The schools participating are: Drexel, Thomas Jefferson, and Penn State in Hershey, PA.
“This research is essential to providing physicians with more evidence-based research to make clinical decisions for their patients,” Pennsylvania Secretary of Health Rachel Levine said in a news release. "It is the cornerstone of our program and the key to our clinically-based, patient-focused program for those suffering with cancer, PTSD, and other serious medical conditions.” The research program comes nearly two years into PA’s medical-marijuana program. 1,140 of the state’s 51,000 physicians are authorized to distribute cannabis to the 106,000 residents who have signed up with the program. PA patients use cannabis in treating conditions such as ALS, autism, and cancer. These three research-partnership approvals came after unforeseen delays with the program. Endorsement by state officials made Pennsylvania’s legalization of medical cannabis unique in comparison to other states.
The state had to make minor changes to the medical-marijuana law, passed in 2016, to correct a loophole pertaining to a lawsuit that challenged the legality of the introductory version of the research program, which allows medical schools to choose their growers. Then, in December, regulators dismissed all eight applications from the primary round of applicants, stating that they were not finished and that they were filled with errors. Among those given denials Thursday were growers partnered with Temple, Philadelphia College of Osteopathic Medicine, and the University of Pennsylvania. The permits would have additionally permitted growers to set up six dispensaries. Permit rejections were also sent to growers partnered with the University of Pittsburgh and Lake Erie College of Osteopathic Medicine, in Erie. A third round of applications is expected, but does not have a timeline yet, a Health Department spokesperson stated.
The health systems will create research studies for the cannabis companies they are partnered with. The researchers will be prohibited from working with the plant or its products, because federal law does not allow marijuana in any form. If the drug were to be handled it would compromise federal grants and funds coming from Medicare and Medicaid. This means patients will be self-reporting data, which may make any research void of consideration by routine, peer-reviewed, scientific journals.
Each company will enlist subjects for study, collect patient data, and provide that information to the health system research team. The companies must pay for any, and all, research expenses. Several of Pennsylvania’s current operational commercial cannabis companies state they are already providing patients’ data with the research institutions. PA Options for Wellness Inc., affiliated with Penn State College of Medicine in Hershey; Agronomed Biologics LLC, affiliated with Drexel University College of Medicine; and MLH Explorations LLC, affiliated with Sidney Kimmel Medical College at Thomas Jefferson University are the three grower/processors approved for research. “We are delighted that the state Department of Health has awarded a clinical registrant permit to MLH Explorations LLC, with whom we have entered into a definitive services agreement and research agreement,” a spokesperson for Jefferson said.
Jefferson stated that its research will include an examination of “the impact of medical marijuana on the quality of life in patients with serious medical conditions” and the collection and cataloging of “which doses and forms of medical marijuana relieve symptoms in specific medical conditions.”
Agronomed Biologics LLC, partnering with Drexel, plans to grow cannabis in Chester, PA. Chief executive Jonathan Cohn stated that the company has six months to open the growing facility as well as a dispensary. As for Agronomed’s work with Drexel, “we’ll come together with a candidate list of research studies we want to perform, and they want to perform, prioritize those, and then kick them off,” he stated. Drexel’s clinical trials will explore the use of medical cannabis in treating conditions such as HIV, neuropathies, and PTSD, Drexel stated. Initial studies are expected to review the treatment of autism and opioid addiction using medical cannabis. Penn and PCOM expressed their disappointment about having their clinical registrant applications rejected.
The Health Department stated that it will meet in July with the medical schools and the three approved companies to discuss their research and plans for patients. Agronomed Biologics is an affiliate of Agronomed Pharmaceuticals, our companies are extremely excited and honored to be able to contribute to the medical advancement of cannabis, in Pennsylvania and the country.