CytoDyn ha pubblicato un report -
10-Q: Quarterly report pursuant to Section 13 or 15(d) - in cui parla dei brevetti e delle richieste di approvazione all'FDA per "diverse formulazioni" del PRO 140.
Per riassumere brevemente a che punto siamo:
Clinical Trials Update
Phase 2b Extension Study for HIV, as Monotherapy. As previously disclosed, there were 11 trial participants in the extension study
who successfully passed 29 weeks of therapy and were not discontinued. Currently, 10 out of those 11 trial participants are approaching two
years of suppressed viral load, with PRO 140 as a single agent therapy. This extension study remains ongoing.
Phase 3 Trial for HIV, as Combination Therapy. A pivotal 25-week trial for PRO 140 as a combination therapy to existing HAART
drug regimens originally designed for 300 patients. One patient has completed this trial and has transitioned to a compassionate use (rollover)
protocol, as requested by the treating physician to enable the patient to continue with a suppressed viral load. Previously, the FDA
agreed to reduce the number of patients in this study from 300 to 150 patients. Most recently, the FDA agreed to additional protocol
modifications, including a further reduction in patients for this trial from 150 to 30 patients and lowered the primary endpoint for viral load
reduction from a viral load of 0.7log to viral load of 0.5log. Based upon these new protocol modifications, management will revise and
update its total cost estimate of this trial, which is expected to be significantly lower than the original estimated range of $12 million to $14
million.
Investigative Trial for HIV, as Long-term Monotherapy. A strategic trial including 300 patients to assess the treatment strategy of
using PRO 140 subcutaneously as a long-acting single-agent maintenance therapy for 48 weeks in patients with suppressed viral load with
CCR5-tropic HIV-1 infection. The primary endpoint is the number of patients who can maintain suppressed viral load under a PRO 140
monotherapy replacing their HAART regimen for 48 weeks. The secondary endpoint is the number of weeks a patient is off of their ART
regimen. Enrollment of first patient is expected to occur within the fourth quarter of calendar 2016 and is expected to accelerate, as
experienced in the previous Phase 2b monotherapy trial. Management estimates the total cost of this trial to range from $15 million to $17
million.
Phase 2 Trial for Graft versus Host Disease. This Phase 2, randomized, double-blind, placebo-controlled, multi-center 100-day study
with 60 patients is designed to evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GvHD prophylaxis treatment
for prevention of acute GvHD in adult patients with acute myeloid leukemia (“AML”) or myelodysplastic syndrome (“MDS”) undergoing
allogeneic hematopoietic stem cell transplantation (“HST”). Enrollment of the first patient is expected in the fourth quarter of calendar
2016. Management estimates the cost of this trial to be approximately $3.5 million to $4 million.
For the three months ended August 31, 2016 and August 31, 2015, operating expenses totaled approximately $5.4 million and $6.7
million, respectively, consisting primarily of research and development, stock based compensation, salaries and benefits, professional fees,
legal fees, amortization and depreciation and various other operating expenses. The reduction in operating expenses of approximately $1.3
million reflected lower research and development of approximately $1.6 million, coupled with reduced legal fees of approximately $0.2
million. General and administrative expenses for the three months ended August 31, 2016 increased approximately $0.5 million over the
comparable period a year ago due to higher salaries owing, in part, to increased number of employees and increased expenses for certain
professional fees and corporate insurance coverages. We expect our research and development expenses to begin to trend higher again, as
we continue our self-sponsored and funded Phase 3 trials with our drug candidate PRO 140, and we continue with activities related to
manufacturing cGMP PRO 140 material for future use. Our ability to continue to fund our operating expenses will depend on our ability to
raise additional capital. Stock-based compensation may also increase, as we continue to compensate consultants, directors, and employees
with stock options and warrants. [...]
The future trends in all of our expenses will be driven, in part, by the future outcomes of clinical trials and the correlative effect on
research and development expenses, as well as general and administrative expenses, especially FDA regulatory requirements, in addition to
the manufacturing of new commercial grade PRO 140, along with the necessary regulatory processes to confirm its qualification for future
sale, if approved. Our ability to continue to fund operations will continue to depend on its ability to raise additional capital. See, in
particular, Item 1A Risk Factors in our Annual Report on Form 10-K for the year ended May 31, 2016. [...]
We have not generated revenue to date, and will not generate product revenue in the foreseeable future. We expect to continue to
incur operating losses as we proceed with our clinical trials with respect to PRO 140 and continue to advance it through the product
development and regulatory process. The future trends of all expenses will be driven, in part, by the future outcomes of the clinical trials
and their correlative effect on general and administrative expenses, especially FDA regulatory requirements, in addition to the
manufacturing of new commercial grade PRO 140, along with the necessary regulatory processes to confirm its qualification for future
sale, if approved. The Company will require a significant amount of additional capital in the future to fulfill BLA requirements related to
manufacturing PRO 140 for commercial use.