ASCO15 EXCLUSIVE: Onxeo Will Run Phase III Trial For Oral Mucositis By End of 2015, CEO Tells BioSpace

ASCO EXCLUSIVE: ASCO Will Run Phase III Trial For Oral Mucositis By End of 2015, CEO Tells Onxeo
May 29, 2015
By Riley McDermid, Breaking News Staff

French biotech Onxeo saw positive enough data from its oral Mucositis drug Valdive to push the drug into Phase III trials by the end of 2015, the company’s chief executive told BioSpace Friday, as the world gears up for next week’s seminal American Society of Clinical Oncology (ASCO) in Chicago.

In an interview with BioSpace, Judith Greciet, director and chief executive officer of Onxeo, said the company remains hopeful about a therapy that treats an extremely painful condition, severe oral mucositis (SOM), which often afflicts patients with head and neck cancer receiving chemoradiation.

1. Explain why this Validive data could be important or a game changer.

Oral mucositis remains a high unmet medical need as it is one of the most frequent and debilitating complication of chemoradiotherapy in patients with head and neck cancer.

At severe stage, oral mucositis induces high level of pain and the inflammation is such that patients are unable to eat solid food, then not even liquid food, leading to enteral or parenteral nutrition and hospitalization as well as anticancer treatment stops or delays. In Head and Neck cancer, it is considered that up to 60 percent of the patients will suffer from severe oral mucositis.

Current protocols include “mouth washes” with various topical drugs such as local anesthetics or pain reliefs.

There is currently no effective treatment that proved to either cure or prevent oral mucositis in solid tumors like Head and Necks and this condition is therefore a very high medical need.

Based on this encouraging Phase II and as per the recommendation of Onxeo’s board of experts, Onxeo is planning to initiate a Phase III trial, and if outcomes are positive Validive could be the first effective drug preventing this severe condition.

2. Message on Onxeo Validive Data at ASCO?

The final data from Onxeo’s global Phase II clinical trial of Validive (clonidine Lauriad) show the therapy’s favorable safety profile and efficacy in reducing severe oral mucositis (SOM) in patients with head and neck cancer receiving chemoradiation therapy. These data establish Validive as a viable treatment candidate for head and neck cancer patients suffering from SOM.

These positive results also provide the basis for a Phase III trial to further evaluate Validive’s efficacy and we plan to initiate the study by the end of 2015.

In addition, we received fast-track designation from FDA for Validive in January 2014, which will help accelerate the pathway to potential FDA approval and allow us to optimize development and review time for Validive, with the goal of bringing this therapy to patients with SOM more quickly.

The full Validive data will be presented during the Head and Neck Cancer poster session (Poster #381, Abstract # 6058) on Saturday, May 30 from 1:15 - 4:45 p.m. CDT at the ASCO Annual Meeting.

3. What do you consider to be company milestones in 2015?

In 2015, a major company milestone relates to Validive, as we prepare to initiate the Phase III trial.

Livatag, doxorubicine nanoformulated developed in the treatment of Hepatic Cell carcinoma, is currently in phase III. In order to meet our timelines, which are to announce preliminary outcomes in early 2017, we are expanding the trial to new sites and countries and should add about 15 additional sites to the 45 actives ones by the end of the year.

For Beleodaq, HDAC inhibitor registered (approved) as 2nd line treatment of PTCL (Peripheral T-Cell Lymphoma) and promoted by our U.S. partner Spectrum Pharmaceuticals, Inc. in this territory, is planned to be evaluated in PTCL 1st line as well as in additional indications in the future.

In 2015, the phase I results of assessment of the safety of the combination Beleodaq + CHOP are expected by second half of 2015. Validation of combination tolerance is needed and will allow PTCL 1st development initiation (planned in 2016).

Other data , including ones that have been published at ASCO this year, are available on various tumor types and combination profile, bringing great value at the moment where we are finalizing the belinostat (Beleodaq) product further clinical development plan.

Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”

Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.

“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”

We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?

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