This excerpt taken from the BCRX 8-K filed Oct 26, 2005.
During the third quarter, BioCryst continued to make significant advancements in its clinical and corporate programs, said Charles E. Bugg, Chairman and Chief Executive Officer of BioCryst. Earlier this month we filed with the FDA a Request for Special Protocol Assessment (SPA) for our pivotal Phase IIb trial of Fodosine in the treatment of T-cell leukemia. The SPA proposes that the trial will be a pivotal study using both intravenous and oral formulations of Fodosine for the treatment of relapsed and refractory T-cell leukemia patients. Assuming we are able to come to agreement with the FDA on a suitable study design, we are on track to initiate the Phase IIb pivotal trial in the first quarter of 2006.
Dr. Bugg added, We are currently finishing a multi-dose Phase Ib trial of our second-generation PNP inhibitor, BCX-4208. Data from this study will be added to that from the recently completed single escalating dose Phase I trial. This Phase I data package will be used to support future Phase II studies of BCX-4208 in multiple indications, potentially including psoriasis, rheumatoid arthritis, Crohns disease and transplant rejection. The company expects to initiate a Phase II trial of BCX-4208 in the treatment of psoriasis patients in 2006.
Additionally, we have continued to make progress in our pipeline programs including BCX-4678, our hepatitis C polymerase inhibitor and peramivir, our influenza neuraminidase inhibitor. We believe that BCX-4678 and the other compounds included under our patent applications represent a new direction for inhibiting hepatitis C, and we are now in the process of completing the preclinical package to file an Investigational New Drug (IND) application with the FDA during the first quarter of 2006.
We have long believed that injectable peramivir has considerable potential, and with the rising incidence of avian flu this spring we began bringing peramivir forward for the parenteral treatment of influenza-infected patients. We are currently on track to file an IND with the FDA this November, and if the Agency approves our plan, we will begin clinical testing early in 2006.
Alongside the clinical development of our lead product candidates, we are actively involved in partnering discussions for Fodosine and BCX-4208. Our strategy is to retain significant rights for marketing in the U.S while engaging partners who can assist with development and international commercialization. By leveraging a partners experience and infrastructure, we will look to offset clinical and marketing expenses, moving our programs forward as effectively as possible.
The next six months should be an exciting time for BioCryst and I am enthusiastic about our upcoming clinical and corporate milestones, said Dr. Bugg.
This excerpt taken from the BCRX 8-K filed Aug 3, 2005.
BioCryst continues to make significant advances in its corporate and clinical programs, and we believe we could potentially start the Phase IIb trial of our lead PNP inhibitor, Fodosine by the end of this year, said Charles E. Bugg, Chairman and Chief Executive Officer of BioCryst. We expect that trial will be a pivotal study using both intravenous and oral formulations of Fodosine for the treatment of relapsed and refractory T-cell leukemia patients. In support of the Phase IIb trial of Fodosine, we are in the process of compiling the Special Protocol Assessment we discussed with the FDA in March and expect to submit those documents to the FDA within the next two weeks.
Dr. Bugg added, Within the next few days, we plan to initiate a second Phase I trial of our second-generation PNP inhibitor, BCX-4208. That trial will be an escalating, multi-dose pharmacokinetic study of BCX-4208 in healthy volunteers. We believe the trial will provide us with the additional safety and pharmacokinetic data necessary to support Phase II studies of BCX-4208 in multiple indications, potentially including psoriasis, rheumatoid arthritis, Crohns disease, transplant rejection and graft vs. host disease. We expect the first Phase II clinical trial of BCX-4208 to be initiated in psoriasis patients toward the end of this year or early next year.
Parallel to our clinical work, we have recently initiated broad discussions with potential pharmaceutical and biotech partners to work with BioCryst in bringing our programs forward to the market. We are continuing to advance our programs steadily through clinical development while these discussions are underway, and we do not have any fixed partnering agenda. The goal is to align ourselves with partners that can help with international development of our drug candidates, offset the financing of the clinical development programs, and provide the large marketing clout necessary to maximize the value of our therapeutics while BioCryst retains co-promotion rights in the U.S.
2005 has already been an exciting year for BioCryst and I am enthusiastic about the milestones still to come, said Dr. Bugg.
This excerpt taken from the BCRX 8-K filed Apr 21, 2005.
Our two lead product candidates made good progress this quarter, and we could potentially have a pivotal phase II trial starting before year-end, said Charles E. Bugg, Chairman and Chief Executive Officer of BioCryst. We had a constructive meeting with the FDA in late March to review current results from our ongoing Phase IIa clinical trial with Fodosine in T-cell leukemia patients, and to discuss our proposed design for the Phase IIb clinical trial, which we expect to initiate later this year. Based on our meeting, we are developing the protocol for a pivotal Phase IIb trial using both intravenous and oral formulations of Fodosine for treatment of relapsed and refractory T-cell leukemia patients, and we plan to conduct the trial under a Special Protocol Assessment from the FDA.
Dr. Bugg added, During the first quarter we also completed a large Phase I trial with BCX-4208, our second-generation PNP inhibitor being developed for treatment of patients with T-cell mediated autoimmune diseases. Based on the positive results of the first trial, we next plan to complete a multi-dose Phase I trial in healthy volunteers during the second quarter. Assuming that trial is also successful, we expect to initiate a Phase II clinical trial in psoriasis patients during the second half of this year.
This excerpt taken from the BCRX 8-K filed Feb 2, 2005.
I am very enthusiastic about the progress we made during 2004, particularly during the fourth quarter with our two lead drug candidates forodesine and BCX-4208, said Charles E. Bugg, Chairman and Chief Executive Officer of BioCryst. During 2004, we initiated a Phase II trial with forodesine in advanced T-cell leukemia and one of our clinical investigators presented the data obtained to date at the American Society of Hematology in December. We are planning to meet with the FDA in early 2005 to discuss these results and prepare for the next phase of this trial.
Significantly, we initiated clinical development of oral formulations for both drug candidates. Our forodesine clinical program now includes a Phase I trial with the oral formulation in patients with cutaneous T-cell lymphoma. In addition, we entered the clinic with BCX-4208, our second generation inhibitor of the enzyme purine nucleoside phosphorylase (PNP), as an oral, once a day formulation. This initial clinical trial with BCX-4208 will enroll 84 healthy volunteers, and should be completed in the first quarter of 2005. Assuming the results are favorable, we expect to complete a small multi-dose trial with BCX-4208 in healthy volunteers during the second quarter of 2005 and move into a Phase II trial in psoriasis patients at mid-year.