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Nirvana Life Sciences Inc (NIRV) RSS Feed

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https://nirvanalifescience.com/
 

Welcome to Nirvana Life Sciences

We are focused on developing medical products and regimens that address addiction.

Click to learn more
 
 

Our Mission

Nirvana was founded with the intent to develop novel therapeutic products derived from psychedelics.

There is a body of research that leads to the conclusion that psychedelic based medicines can offer new approaches to pain management as well as treatment for ailments such addiction, anxiety and depression.

We believe that using naturally sourced psychedelics in novel  formulations holds the promise of delivering non-addictive solutions that are effective in managing pain and addiction.

Opioid Addiction

Opioid addiction has become a major health crisis that has a massive cost to our society. Existing approaches to breaking addiction have not been successful.

A Successful Approach

A successful approach to break addiction and offering non-addictive pain management products will offer great benefit to society and a successful drug development project for the Company.

The Company’s Goal

The Company’s goal is twofold; to develop psilocybin derived medicines that can break human addictions to Opioids, and non-addictive pain relief that can replace the need for Opioid medicines.

Our team, consisting of leading researchers from around the globe, aim to develop therapies that have the potential of freeing millions from addiction and saving society billions of dollars annually.

 

Situation

Addiction to Opioids has become a global crisis.

For many years, the pharmaceutical Industry has promoted the use of highly addictive pain medications to millions of patients. While these medications have been effective for pain relief, the highly addictive nature of the medications has created a problem with no practical  solution. The result has been millions of people becoming addicted to opioid medications, some who have turned to street versions of these drugs to manage their pain.

The actions of these pharmaceutical companies have a devastating impact on families and communities. Current solutions proposing free or lower cost opioids is not a solution, society needs practical methods to break addiction, prevent relapse and replace addictive pain management therapies with non-addictive therapies.

Cost of Opioid Crisis in America

The US Council of Economic Advisors estimate the cost to the US  economy at more than $500 billion annually, this equates to -almost 4% of GDP. In 2017, more that 70,000 Americans died of drug overdose, with around two-thirds of those deaths linked to opioids. The impact can be measured financially, with massive  health care and insurance costs as well as the significant costs of law enforcement. It has been estimated that it will require a large investment, as much as $100 billion, to fully address the crisis.

 

Four Pillars of Success

Research & Development of IP
  • Acquired the IP behind these novel formulations
    Commencing de novo research on a number of additional formulations
Development of Processes to support production
  • Acquired a license for the extraction technology
    Developing a proprietary process for purification of the materials
    Developing a scalable process for producing inputs
Clinical Trials
  • Each of these formulations will be put through pre-clinical trials
Product Development
  • Developing therapeutic products using novel psychedelic compounds
    Targeting a soft-gel format for the addiction focus product
 

Breakthrough Research

The Company’s Scientific team is taking theories developed by researchers in the 60’s and 70’s and applying modern approaches to developing novel psychedelics-based formulations. Company researchers believe that its Psilocibyn formulation may also be effective at preventing relapse. Nirvana has begun pre-clinical trials into the efficacy of Psilocybin based formulations as a therapeutic tool to break addiction to opioids.

Clinical Studies are led by Dr. Massimo Nabissi, of the University of Camerino (Italy), with the support of Dr. Sazzad Hossain. Ongoing pre-clinical trials to validate that the Psilocybin based formulation is effective at breaking addiction is the first step. This will be followed with further development of psychedelics-based formulations that may eventually create a range of potential products based on results of these trials.

UniCam has proposed additional studies for use of the formulations for Anxiety and Depression which can be undertaken in further phases of the project. Further trials have been planned for a range of formulations under development.

Initial Products

The Company has selected two products for its first phase of development.

Click to learn more
 
 

Two Products

A one-per-day slow release gel cap that assists transition from opioids to non-addictive pain relief therapies.

A one-per-day slow release gel cap that delivers non-addictive pain relief.

 

Development of similar products in a transdermal patch format will also be pursued. These prototype products will enter the next phase of development in the third quarter of 2022.

 

Therapeutic Products

Any number of therapeutic medicines and products can be created from our formulations. As many of our formulations will be dealing with the treatment or management of opioid addiction or dependency, we have prioritized the development of non-abusive delivery systems. This will be an advance over conventional delivery systems such as tablets or inhalants that can be abused by over consumption and overdosing.

Our scientific team has been successful at developing various formulations to deter the possibility of abuse by developing and using various methods of ‘compound coupling’.

What this entails is attaching a natural backbone to the active compounds chemical structure to form a ‘complex’. This can be done using safely approved amino acids and metals salts. The medicines produced via this method would be rendered inactive if consumed in any manner other than orally because the formulation must first pass through the gut in order to break the active compound free from its coupled backbone. IV use or insufflation would not be effective at releasing the active thus rendering it safe.

Novel Formulations

The company has purchased a portfolio of Intellectual Property from researchers with vast experience in the psychedelics space.

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Nirvana’s researchers have developed formulations based on  psychedelics for aiding patients who are addicted to opioids to transition off these substances
  • The “Relapse” formulation is the focus of much of the teams attention.
    The Company will take the formulations and enter a standard drug development process.
    Formulating the active ingredient for safe and standardized use as an oral medication is the key to establishing an overall quality FDA approved medication.
Since Psilocin begins to degrade almost immediately when exposed to oxygen, we have developed a delivery media that protects the active from coming into contact with air.

Also, since psilocybin potency diminishes upon exposure to water and UV light, our novel carriers and encapsulation process utilize both anhydrous carrier liquids and UVA&B resistant gelatins for our precisely dosed Soft gel capsules.

As legalized medicinal use of psilocin, psilocybin and other naturally derived tryptamines is a new frontier, this leaves open a great deal of opportunity to seize the market on new FDA approved formulations.

In addition to novel formulation development, there is also the opportunity for IP development for the mechanized manufacturing of these new medicines that incorporate our Licensed delivery systems and mechanisms.

 

Extraction of Natural materials

Nirvana is focused on extraction of natural materials to create therapeutic compounds while others have focused on synthetic materials.

The Company’s extraction process development includes large scale extraction, isolation and purification of psilocybin and other active tryptamines from various sources of refined biomass material consisting of both grown fungi and enzymatic de novo crude. Since psilocybin and psilocin are susceptible to rapid degradation when exposed to heat, water and oxygen, we had to develop a viable and cost-effective method of extraction in anaerobic and anhydrous conditions.

The process for synthesizing materials such as psilocybin has been around for many years. In fact, our team members were involved with developing many of the routes steps and the streamlining of the synthesis process.

Producing tryptamines synthetically it is not a cost-effective means of production and will quickly become obsolete once we have perfected our more effective and sustainable routes of tryptamine production.

The reason that no one has come forward with a viable method of extracting active tryptamines from biomass material like mushrooms or mycelium is because it is not an easy process to streamline and the yields have been poor.

PureAI Distillation System

Nirvana has acquired an exclusive license to the extraction and distillation technology for the Psychedelics market. The Company has purchased its first PureAI machine that will be in the Vancouver Lab facility. The Pure AI is a high vacuum fractional distillation system that should allow us to achieve separations of non-tryptamine compounds at a lower temperature than conventional fractional distillation systems.

The pure AI system will be used exclusively to isolate secondary and tertiary compounds that will be used for further research and study and to formulate new medicines. It is this level of research that will separate our work from companies that are simply trying to reach the finish line of API grade extraction of biomass and biomaterial. These isolated compounds will be studied in formulations clinically and our products formulated with these compounds will set us apart in the market.

The Pure AI produces compounds that are pure in nature since the technology has the ability of separating pristine compounds from complex mixtures due to incorporating the use of vapor temperature within a static multiple theoretical plate system.

As only a single compound or component boils at a specific temperature under a high vacuum system, the machine uses this law of physics to separate out pure compounds by both molecular weight and the law of entropy and thermodynamics.

 

Extraction- Synthetic

Dr. Gaur and Dr. Barse of the International Centre for Genetic Engineering and Biotechnology of New Delhi, India has been contracted will undertake a research project on a novel process developed by the Company’s CSO to assess the ability to produce psilocybin materials at scale.

The project is focussing on strain engineering to achieve a cost- competitive large-scale fermentative production of psilocybin with a purity of >98% in kilogram batch quantities for use as an API”

For the next stage we are developing a means of adapting this extraction method for large scale pharmaceutical GMP production of clinical grade psilocybin.

The Company has acquired an exclusive license to a proprietary extraction  technology that will support these developments.

 

Research Facility

The company has secured a location in Vancouver to conduct research that is suitable for this development. The company has received a Section 56 Exemption (research license) from Health Canada. The team has extensive experience planning and building similar facilities.

The facility will be built out to a level 9 Security standard, the 2,500 square foot lab space will facilitate all foreseeable activities as well allowing for scaling and expansion. These activities will include research of novel compounds, extraction and purification methods. The Company has applied to Health Canada for Dealer’s License that will allow for movement of materials between licensees.

Pre-Clinical Research

Nirvana is planning on growing several genera and species of fungi (including rare and hybrid varieties) with a high standard of quality and batch consistency.

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Latest Update

  • Integrated Therapy Discovery Labs, based in Camerino Italy, has been contracted to conduct a series of pre-clinical research projects
    ITD is led by Dr. Massimo Nabissi, Dr Nabissi is leading this research with the support of Dr Sazzad Hossain.
    The ITD Lab was granted special permission from the Italian government to work with these Psilocybin based compounds.
    The Company began a series of pre-clinical trials in the spring of 2021
    This research is considering the efficacy of Psilocybin based formulations as a therapeutic tool to break addiction to opioids.
    The relapse project is based around this research

Psilocybin and Psilocin

Using fungi to extract the active tryptamines from the biomass to yield psilocybin and psilocin in the form of pure crystalline isolate, salts, tinctures and high bioavailable water-soluble liquids and dry powders. Nirvana plans to sell these products to other researchers under a Dealer’s License from Health Canada.

The extraction of psilocybin and other structurally similar substituted tryptamines from fungi followed by their conversion to the metabolic prodrug 4-POpsilocin. This process is a novel method to yield a new  psychoactive substituted tryptamine that has a highly desirable effect.  The onset is fairly rapid and the duration is roughly 4 hours.

This novel compound will be ideal for use in a clinical setting due to its short duration and the lack of any apparent body load that’s often associated with psilocybin. We are currently in the finalization phase of the patent process and acquiring this compound for exclusive use in the clinical pharmaceutical market.

Nirvana is also in the process of creating a fully synthetic route to yield psilocybin and psilocin from 4-hydroxytryptophan in large batch quantities. This synthetic psilocybin will be a standardized USP grade  pharmaceutical.

 

Iboga and Ibogaine (Tabernanthe Iboga)

Ibogaine is a naturally occurring alkaloid that has been reported to decrease various adverse phenotypes associated with exposure to drugs of abuse and alcohol in human and rodent models. We believe that this compound could be valuable as a clinical  medication when used cautiously. We have developed an exclusive multi-phase process to extract  ibogaine alkaloids from the root bark of the tabernanthe iboga shrub. This extraction process yields both a broad spectrum total alkaloid  freebase powder and a pure hydrochloride salt. We are currently in the process of developing a cost effective batch  scale synthesis of noribogaine and its 13-hydroxy variant. Noribogaine (12-hydroxyibogamine) is a metabolite of ibogaine.

In addition to novel formulation development, there is also the opportunity for IP development for the mechanized manufacturing of these new medicines that incorporate our Licensed delivery systems and mechanisms.

About Us

We are focused on developing medical products and regimens that address addiction.

Learn More
 
 
Board of Directors

Annie Storey

Edward Lupton

Chris Hoffmeister

Mark Marissen

Bruce Clark

Bruce Clark

Chief Executive Officer

Mr. Clark leads the Nirvana team, seeking new solutions to one of our society’s most confounding issues. He sees great potential in the opportunity to development of new approaches to a complex problem which is both a public health and economic issue for our communities. Mr. Clark is a proven innovator who brings 30 years management experience across a variety of industries, including energy, food and beverage manufacturing and life science. He possesses broad experience in product development, manufacturing and product distribution and a clear understanding of the regulatory process. He has a deep understanding of the public policy issues at play and the importance of collaboration with all levels of government and health professionals through the development process.

Connie Hang, CPA

Chief Financial Officer

Ms. Hang has over 20 years of finance, accounting, and management experience in a variety of industries, including energy, mining, and health science.

In the past 12 years Ms. Hang has acted as an advisor, officer and/or director for various  public and private companies, which span across Canadian based companies to  foreign controlled entities.

From 1999 to 2009, Ms. Hang worked in professional  accounting firms and held senior positions in tax and audit practices.

Having served over 40 public and private companies, which span across Canadian based companies to foreign controlled entities, she has gained in- depth knowledge of financial and regulatory affairs.

Her experience in dealing  with people from different cultures and disciplines has solidified her ability to  understand the needs of stakeholders and communicate complex ideas.

Ms. Hang is a Member of the Chartered Professional Accountants of Canada and  British Columbia and holds a Bachelor of Accounting Science from University of  Calgary.

Dr. Sazzad Hossain PhD

Chief Scientific Officer

Dr. Hossain is the former Chief Scientific Officer of InMed Pharmaceuticals Inc., a leading public Canadian bio-pharmaceutical company.

Previously he worked as Senior Scientist at Biotechnology Research Institute of National Research Council Canada.

Dr Hossain is a drug discovery leader over 15 years of biotech/pharmaceutical experience with small molecule & biologics in multiple disease indications.

He has experience in accelerated drug discovery and commercialization process with combined experience in preclinical in vivo pharmacology, DMPK, safety & toxicology.

He has led teams in the strategic design of new natural health products and generated hundreds of millions of dollars in revenue by leading development of multiple successful compounds.

Dr Hossain holds a PhD in Biology and was  a post doctoral Fellow at the Centre for Molecular Medicines and Therapeutics at the University of BC

Robert August IV, MSc

Head of Innovation

Robert August is an academically trained medicinal chemist  with a focus on ergolines, phenethylamines and tryptamines.

Robert began his academic career at Loyola University in  Baltimore, Maryland. During his undergraduate years, Robert  worked as an analytical chemist for Martel Laboratories where  he received his state analytical certifications for ICP, GC/MS  and LC/MS operations. While pursuing a post graduate degree  in medicinal chemistry at Johns Hopkins University, Robert  turned his focus toward the synthesis of psychoactive and  psychedelic compounds, namely ergolines such as LSD and  phenethylamines like MDMA and 2CB.

It is during this time that  Robert began to work as a research chemist and, eventually,  began to actively pursue working partnerships with other  chemists who were researching psychedelic compounds like  Dr. David E. Nichols and Nick Sand with whom Robert worked  with briefly in Vancouver, B.C.

After earning a reputation as a skilled chemist, Robert was invited  to work alongside Ben Alkire (Purdue University) in Lafayette,  Indiana where he went on to cofound Berkeley-Clearlight Research  Group.

While forming BCRG, Robert was given unlimited access to the D.E. Nichols Archive at Purdue University and the vast array of  synthesis notes created by Dr. Oberlender during his time as a  chemist for the Nichols team.

In the years that followed, Robert  synthesized numerous novel compounds and research chemicals  and became the first person to synthesize 3,4-MDMA Monohydrate  HCl as a crystalline solid and as a beta ketone. Robert is a highly  respected member of the psychedelic community and an advocate  for ending prohibition.

Michael McCune

Vice President Operations

Mr. McCune is a seasoned entrepreneur and innovator in the extraction space.

Since 2013, he has applied his passion for science to developing novel processes for producing API’s for Cannabis industry. He has built a specialty for at-scale extraction of a wide variety of materials.
He led the development of a leading-edge distillation system that offers significant operational advantages and automation. He has overseen the development, trials and contract manufacture of this system.

Michael is recognized as a lead leader in these technologies and has co-authored several Patents. He maintains a global network and has presented at numerous conferences on the topics of Extraction and Cannabis Technologies.

 

Contact Info


Email us:
investor@nirvanalifescience.com

Nirvana Life Sciences
6th Floor. 905 West Pender St.
Vancouver BC
V6C1L6

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