Clinical trials are a critical phase of development in the field of biotechnology. It can be extremely challenging, but also highly rewarding as a product progresses from smaller, safety trials, to later stage trials involving much larger patient numbers. However, if successful at each stage, companies can find themselves increasing many multiples in value and often find themselves the target of an acquisition, or their product licensed to Big Pharma who have the marketing and sales force capabilities to distribute a potential new blockbuster product.
Understanding more about the different phases of clinical trials:
- Phase I is the first trial involving humans where researchers study how the drug interacts with a healthy human subject..
- Phase II is when the company attempts to prove the drug is effective against a disease target by administering the drug to patients who have the condition..
Be on the lookout for biotech companies with up and running clinical trials. Companies in Phase I or II clinical trials are a strong indication of potential future success.
UPDATES ON PROPANC HEALTH GROUP CORP CLINICAL TRIALS (PPCH)
Insiders and outsiders of the biotech world are hearing more and more about PPCH, the Australian-based biotechnology company seeking to develop new long term treatments for cancer. Propanc has made significant progress advancing towards its first human trials for their lead product, PRP.
PRP targets malignant cancer cells through multiple pathways. As a result, the company believes the product may create a lasting clinical benefit for the patient. Propanc is in the final stages of completing non-clinical studies and intends to file a clinical trial application in the UK later this year. The clinical trials will assess the safety and efficacy of their product against solid tumors. Propanc CEO, James Nathanielsz outlined its development plans for PRP, as the company intends to begin a Phase 1 human study by the end of 2017.
PPCH just announced the successful completion of the low dose group for its GLP-compliant 28-day repeat dose toxicity study. With no safety concerns in the low dose group, Propanc received approval to proceed with the middle and high dose groups from the International Animal Care & Use Committee (IACUC) in Melbourne, Australia.
The company submitted four new patents in the US, Australia, and Spain last year on the dosage and mechanism of action for its two proenzymes used in PRP, two proenzymes, trypsinogen and chymotrypsinogen. With recent approvals of intellectual property rights and patents in various regions around the world, their patents are reaching significant milestones and increasing in value.
IN OTHER BIOTECH NEWS…
According to data from S&P Global Market Intelligence, MannKind Corp. (MNKD), lost 56% of its value over the course of 2016. This drugmaker’s huge downfall was caused by the termination of its license and collaboration agreement with Sanofi for inhaled insulin product last Spring. However, the company has been working to regain some of these losses recently.
If you are attending the American Association for Cancer Research (AACR) 2017 Annual Meeting held April 1-5 in Washington D.C., look out for Affimed N.V. (AFMD). They’re a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. They announced they’ll be presenting preclinical data for their lead candidate AFM13, the Company’s preclinical programs AFM24 and AFM26, as well as data on its MHC-peptide-targeting discovery program.
Eyegate Pharmaceuticals Inc. (EYEG) recently struck a deal with biotech giant Valeant Pharmaceuticals. The deal totals $103 million for the tiny ocular focus biotech, will see Valeant pick up the rights to Eyegate’s lead development asset in a postoperative inflammation indication, and involves both an upfront payment and a raft of milestone rooted cash injections.
The Durham, NC-based company, Novan (NOVN), is pushing on with programs in five dermatological conditions, with its lead candidate, SB204, a topical gel that targets multiple mechanisms of action for the treatment of acne vulgaris–the most common skin disease in the U.S.
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