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A translational story of an idea maturing to a stage III clinical trial

Since 2003, Pharmaseed team members help and advise Biotech and Pharmaceutical companies to  test new technologies in the field of CNS, Vascular, Infectious, Metabolic or Inflammation. Focusing on translational work and new capabilities, Pharmaseed was responsible for the maturation of an innovative idea from the early discovery stage to a Phase III clinical trial tested technology.

 In 2009, Dr. Itschak Lamendorf, Pharmaseed president and founder, and Dr. Yoram Sela, Pharmaseed head of pharmaceutical scientifc board, co-jointly invented and developed a suitable pharmaceutical carrier and a fixed dose combination of two active agents, a dopamine agonist pramipexole and a monoamine oxidase inhibitor rasagiline, indicated for the treatment of Parkinson’s disease.

The combination of the two agents was tested and optimized on different in vitro, as well as in vivo  Parkinson’s Disease pre-clinical model, within Pharmaseed facilities. Pharmaseed’s preclinical testing of the compound provided a solid justification and rationale for further development of a product, which adresses pharmacological as well as pharmaceutical needs.

The technology (P2B001) that was owned by the Israeli company Pharma 2B was further developed clinically reaching the advanced stage of a phase III clinical trial.. In 2015, the company announced that  “A Phase IIb, Twelve Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects with Early Parkinson’s Disease”, successfully met its endpoint and in 2017, Pharma 2B raised $30 millions to test P2B001 in a clinical phase 3.

Pharma Two B raises $30M for Parkinson’s phase 3 from Biogen-backed fund, adds ex-Pfizer CEO to board

Pharma Two B has raised $30 million (€28 million) to complete a phase 3 trial of its Parkinson’s asset P2B001. The round provides a hint of the impact of the recently founded Israel Biotech Fund, which led the investment and is adding ex-Pfizer CEO Jeff Kindler to Pharma Two B’s board.

 

 

 

 

Parkinson’s Disease_brochure#1

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Diabetes and sexual dysfunction therapy

 

 Diabetes affects 422 million people worlwide, and is the leading cause of 1.5 million deaths in 2012. For that same year, cardiovascular and other vascular diseases caused by chronic hyperglycaemia led to the death of 2.2 million people. 43% of these deaths occurred before the age of 70 (WHO, global report on diabetes, 2016).

 

Diabetes neurological and vascular diseases complications can lead to higher risks of heart attack, stroke, leg amputation, kidney failure, hearing and vision impairment, and erectile dysfunction.

 

Because of diabetes damages on peripheral nerves and small blood vessels, erectile dysfunction (ED) is a common consequence of this chronic disease. In particular, alterations of the penile endothelial tissue  are a main cause of diabetes-linked ED physiopathology. Chronic hyperglycaemia leads over time to an accumulation of oxidative stress products and AGEs, which in turn induces vascular endothelial molecular alterations (eNOS/NO impairment, protein oxidation, apoptosis) and subsequent functional dysfunctions (Castela and Costa, Nature Reviews Urology, 2016).

Men who have diabetes  are 2 to 3 times more likely to experience sexual dysfunction than healthy men (NIDDK). Drug treatments available are based on Phosphodiesterase5 inhibition. Alternative drug based on enhancing the activity of the A3 adenosine receptor is also being developed.

Can-Fite Announces New Pre-Clinical Data for CF602 Demonstrating Statistically Significant Full Recovery from Erectile Dysfunction After a Single Dose

There is a significant segment of the erectile dysfunction market that is not addressed by PDE5 inhibitors, the class of drugs that are widely used in the market today. Due to CF602’s novel mechanism of action, it may provide benefits for patients who do not respond to PDE5 inhibitors, or cannot take PDE5 inhibitors due to contraindications.

 

We have developed a comprehensive preclinical program to test  sexual dysfunction technologies from early stage R&D to first-in-man:

-In vitro screening of erectile dysfunction: determination of NO, hormones levels.
-In vivo measurements: vasoactivity level measurement
-In vivo models: induced ED in diabetic or hypertensive animals

for more details, please see below or contact us: pharmaseed@pharmaseedltd.com

 

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Cell therapy for vascular diseases

Treating chronic diseases with cells that possess stem-like properties is thoroughly investigated. PDAC® cells are Placenta-derived activated cells that have been shown to have tissue repair, anti-inflammatory and pro-angiogenic properties. These unique traits make them a pertinent source of cells as potential treatment for vascular diseases such as hindlimb ischemia.

Angiogenic properties of human placenta-derived adherent cells and efficacy in hindlimb ischemia. – PubMed – NCBI

J Vasc Surg. 2016 Sep;64(3):746-756.e1. doi: 10.1016/j.jvs.2015.04.387. Epub 2015 Jun 6.

 

These cells are also the object of an ongoing cell therapy clinical trial to evaluate their safety and effectiveness to treat patients with Peripheral Arterial Disease and Diabetic Foot Ulcer.

Study of Human Placenta-derived Cells (PDA002) to Evaluate the Safety and Effectiveness in Subjects With PAD and DFU – Full Text View – ClinicalTrials.gov

This clinical study is being conducted to assess the safety and determine the maximum tolerated dose (MTD) of PDA-002 [human placenta-derived cells] administered into the lower leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer healing.

Pharmaseed as a strong R&D experience for vascular diseases and has developed an extensive angiogenesis program. Our Hind Limb study package includes:

– Evaluation of the efficacy of a test item on angiogenesis

– Functional outcome in mice and rodents

for more details, please see below or contact us: pharmaseed@pharmaseedltd.com

Hind Limb Ischemia program

Pharmaseed has extensive vascular-related diseases know-how. We have developed a comprehensive Hind Limb Ischemia pre-clinical program: – Evaluation of the efficacy of a test item on angiogenesis – Functional outcome in mice and rodents For more information: contact us 

 

 

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