- Promising results have been recorded in the first pilot study of a Rotigotine skin patch for Parkinson’s patients
- Wholly owned subsidiary Vektor is reaching a major milestone in the development of Rotigotine with the potential for a pivotal human trial
- The company is planning the construction of a new lab and manufacturing space up to 32,000 square feet in Biberach, Germany
- Pilot project involving rapid COVID-19 PCR tests has been initiated in Germany, promising efficacy and accuracy of results in as little as 25 minutes
- XPhyto is currently in talks and negotiations with distribution and wholesale partners, with a potential sales launch in Europe during Q2 2021
XPhyto Therapeutics (CSE: XPHY) (OTCQB: XPHYF) (FSE: 4XT), a life sciences technology accelerator, recently announced its 2021 drug formulation programs are on schedule and continue to expand in scope. The company’s drug formulation and development are conducted primarily by its wholly owned German subsidiary, Vektor Pharma TF GmbH.
Vektor is focused on the development of generic and hybrid-generic drug formulations for neurological conditions, with delivery platforms that include oral dissolvable and transdermal systems. The product pipeline targets large and growing markets with a promising potential for patient outcomes.
A Q1 trial announced in January 2021 and focusing on a human bioavailability pilot study of the Rotigotine transdermal patch for Parkinson’s Disease was completed in March 2021. Due to the favorable outcome of the study, the Rotigotine development program will be advanced to include a pivotal human trial (https://ibn.fm/CFyAI).
“Vektor continues to build shareholder value by advancing its product development pipeline. Its lead program is now progressing to a pivotal human study in Europe, which is the final major milestone on the path to commercial regulatory approval,” XPhyto CEO and Director Hugh Rogers explained.
Also earlier this year, the company announced the intention to purchase a property in Biberach, Germany, where it plans to build a new commercial drug manufacturing facility. The estimated maximum capacity of the lab and manufacturing space permitted on the property is 3,000 square meters (32,000 square feet). Scalable construction options are being considered to synchronize manufacturing capacity with demand from both in-house and contractual opportunities.
According to Rogers, the addition of in-house, scalable commercial drug manufacturing capability is expected to add further value and optionality to XPhyto’s drug formulation and manufacturing businesses.
More details about the Rotigotine trial and the Biberach manufacturing facility construction will be made public in due course.
XPhyto also announced that it recently commenced another pilot project with its rapid COVID-19 PCR test in a point-of-care setting in Germany. The test was recently approved in Europe and offers PCR test accuracy in only 25 minutes. During the pilot, validated workflows for the test, including mobile collection and processing of patient samples, will be optimized (https://ibn.fm/sDLKE).
For this pilot project, XPhyto partnered with Spitzweg Apotheke, a well-known pharmacy in Langen, Germany, that is currently running a COVID-19 test center clinic and also provides specialized pharmaceutical services to cancer patients.
“With a specialized oncology pharmacy, many of our customers are in the COVID-19 high-risk group. For these patients, their families, and their close contacts, fast and reliable diagnostics are critical to ensure everyday safety,” the Head of Spitzweg pharmacy, Gabor Perl, said. “PCR tests are the diagnostic gold standard for COVID-19. They provide high sensitivity and specificity. We are pleased to take part in this pilot project and now offer our high-risk-group customers access to a rapid PCR test with immediate results. We believe this is an opportunity for best-in-class healthcare delivery.”
The pilot program’s COVID-19 rapid test, which is used for the positive detection of SARS-CoV-2 (COVID-19), is based on the reverse transcriptase-polymerase chain reaction for results. XPhyto is currently in talks and negotiations with distribution and wholesale partners, with a potential sales launch in Europe during Q2 2021. The company is not making any express or implied claims that its product can eliminate, cure or contain the COVID-19 pandemic.
For more information, visit the company’s website at www.XPhyto.com.
NOTE TO INVESTORS: The latest news and updates relating to XPHYF are available in the company’s newsroom at https://ibn.fm/XPHYF
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