Promising Findings on Pedmark: Enhancing Treatment for Cancer
Promising Results from the Pedmark Study
Fennec Pharmaceuticals Inc. (NASDAQ: FENC) has shared exciting topline results from a crucial study on Pedmark, a sodium thiosulfate injection. This trial focused on reducing cisplatin-induced ototoxicity in pediatric and young adult patients with non-metastatic solid tumors. The study was conducted in Japan and has shown significant positive outcomes.
Pedmark's Unique Position in Cancer Treatment
Pedmark stands out as the only FDA-approved therapy designed to lower the risk of hearing loss associated with cisplatin treatment in children aged one month and older with localized tumors. Cisplatin and similar chemotherapy drugs are integral in treating a variety of solid tumors, making the quest for effective supportive therapies essential.
Study Details and Performance
The study involved 27 patients aged between 3 and 18 years in the main cohort, alongside six patients in exploratory cohorts. The administration of Pedmark occurred six hours post-cisplatin treatment, aiming to mitigate potential hearing loss.
Key Findings: Reduced Hearing Loss Rates
Encouragingly, the primary endpoint of the study was achieved. The results revealed that 24% of evaluable patients treated with Pedmark experienced hearing loss, as measured by American Speech-Language-Hearing Association criteria, and 16% based on Brock grading. These figures are notably lower than the historical averages seen in previous pivotal trials of Pedmark, where 56% of children faced clinically significant hearing loss.
Subgroup Analysis
Diving deeper, the analysis of the largest subgroup comprising patients aged 7-18 years showed even better outcomes, with only 19% experiencing hearing loss under ASHA criteria, and just 14.3% under the Brock grading system. These outcomes underscore the potential of Pedmark in minimizing the risks commonly associated with cisplatin treatment.
Safety and Efficacy of Pedmark
Pharmacokinetic evaluations indicated that pedmark did not diminish the effectiveness of cisplatin nor was there any adverse interaction noted. In fact, the overall tumor response rate remained impressively high at around 95%, confirming that Pedmark maintains its antitumor activity without compromising patient safety.
Importantly, Pedmark was well-tolerated throughout the trial, with over 200 reported adverse events where none were linked to the therapy itself. This safety profile bolsters confidence in Pedmark as a supportive treatment during chemotherapy.
Future Plans for Pedmark
Fennec Pharmaceuticals is keen on continuing its positive trajectory with Pedmark. The company plans to pursue regulatory registration in Japan and explore potential partnerships or licensing arrangements to broaden the accessibility of this innovative therapy. Full details of the study will be unveiled in upcoming scientific presentations and submitted for publication in peer-reviewed journals.
FENC Stock Performance
In market activity, shares of Fennec Pharmaceuticals saw a slight decline of 0.78%, settling at $7.85 on the publication date. Investors remain hopeful as the results from this study have the potential to enhance the value of the company's offering in the oncology market.
Frequently Asked Questions
What does Pedmark do?
Pedmark is a sodium thiosulfate injection approved by the FDA to reduce the risk of hearing loss caused by cisplatin chemotherapy in pediatric patients.
What were the findings of the recent study on Pedmark?
The study demonstrated that only 24% of participants treated with Pedmark experienced hearing loss, which is significantly lower than historical rates.
Is Pedmark safe for children?
Yes, the study found that Pedmark was well-tolerated, with no adverse effects linked to the drug during the trial.
What are Fennec Pharmaceuticals' future plans for Pedmark?
Fennec plans to pursue regulatory registration in Japan and seek partnership opportunities to expand the availability of Pedmark.
How did Fennec Pharmaceuticals' stock perform following the study announcement?
Fennec Pharmaceuticals' shares declined by 0.78%, trading at $7.85 at the time of the announcement, reflecting investors' cautious optimism in response to the study results.
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