Promising Signals Emerge from Two Phase II Cancer Studies
Two biopharma companies developing therapeutics in the oncology space reported strong signals in Phase II.
Tetra Bio-Pharma made the cut in two ongoing clinical trials for its novel cannabinoid-derived drug aimed at alleviating the pain experienced by cancer patients.
QIXLEEF, a new botanical inhaled drug, is being developed as a possible alternative to the opioids traditionally used in cancer pain treatment. It has a fixed ratio of THC and CBD that complies with the USA cGMP regulatory requirements.
The Canadian biopharma company announced Monday that it has achieved positive initial clinical data with regards to the REBORN 1 and PLENITUDE trials
In the REBORN 1 study, QIXLEEF demonstrated favorable tolerability and a good safety profile in terms of breakthrough pain. The report added that negative reactions emerged only in mild levels and that no serious adverse events resulted from the study.
The same profile was seen in the PLENITUDE trial, which confirms the safety and tolerability of QIXLEEF in this batch of clinical participants who were treated with the drug.
"A safe and efficient therapeutic alternative that allows the reduction of opioids is critical now more than ever to support patients in their journey against pain,” said Tetra CEO and Chief Regulatory Officer Dr. Guy Chamberland, M.Sc., Ph.D. “Preliminary data from both REBORN©1 and PLENITUDE© confirm the safety and pharmacodynamic profile of QIXLEEF™ reported in the phase I trials. The pharmacokinetic profile of QIXLEEF™ is well indicated to help manage short episodes of pain such as breakthrough pain and will offer patients and physicians a viable, safer, and non-opioid option for pain management."
Preliminary data analysis showed a positive effect on pain relief, though the company is barred from disclosing further detail due to regulatory compliance.
Starpharma Scores Too
Starpharma, a biopharma company in Melbourne, announced positive interim results from its ongoing Phase II trial of drug candidate DEP cabazitaxel. The update discussed the interim results and efficacy findings in prostate cancer. The company noted that the intake of DEP cabazitaxel led to a significant decrease in severe bone marrow toxicity.
Starpharma claims that all of the patients with Stage IV metastatic prostate cancer who participated in the trial displayed favorable efficacy responses, making use of one or more standard measures of prostate cancer, which is the second-most common cancer among men globally.
The company reported that 64% of the 51 participants with assessable tumor lesions saw prolonged stable disease and significant reductions in tumor size for up to 36 weeks.
The announcement also listed that the lesions either did not progress or improved in 83% of the patients suffering from secondary bone disease.
In addition, 90% of the subjects with assessable PSA (Prostate Specific Antigen) tumor biomarker levels had a decline in PSA, whereas over half of them achieved a drop in PSA of at least 50%. In total, 56% of the participants displayed responses across all three measures.
“These positive results for DEP cabazitaxel in Stage IV prostate cancer patients are really exciting news for Starpharma and our DEP platform,” said Starpharma CEO Dr. Jackie Fairley.
DEP cabazitaxel is a nanoparticle form of the long-established cancer drug Jevtana. The new drug is being tested on 51 participants with varying types of cancer at different clinics in the U.K. and Australia.
In another note, Professor Anthony Joshua, study investigator from the Kinghorn Cancer Centre in Sydney said, “The trial results to date for DEP® cabazitaxel in heavily pre-treated prostate cancer patients are highly encouraging and indicate the potential of the product compared to standard cabazitaxel. The anti-cancer activity, together with less myelosuppression than standard cabazitaxel and a generally well-tolerated safety profile, mean this novel form of dendrimer-enhanced cabazitaxel represents a useful option for prostate cancer patients, including in older patients in whom DEP® cabazitaxel has been particularly well tolerated.”