CRs:
Here is the relevant transcript where the two CRs are detailed as best as I could find it (see bold part). I do intend to follow up with a question, hoping that some here can provide insight / opinion.
CORPORATE PARTICIPANTS
Donald Kiepert
Point Therapeutics, Inc - Chairman and CEO
Margaret Uprichard
Point Therapeutics, Inc - SVP, Chief Development Officer
PRESENTATION
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
Good morning my name is Don Kiepert and I am Chairman and CEO of Point Therapeutics. I would like to thank you for taking the time to join us with today's Webcast. As we begin the New Year the Point Team felt it was timely to organize a forum to welcome new shareholders and to address our long term supporters.
2005 was a pivotal year for our company. Significant progress was made in advancing talabostat through the clinic. We've been reporting individual trial results at scientific meetings throughout the year. In addition, the data from those trials has continued to mature since those meetings. I thought it was important to provide an update on all of our clinical trials with emphasis on our Phase III non-small-cell lung cancer program. Thus the purpose for today's Web cast. During and after our presentation, you will have an opportunity to email questions which will be addressed after the presentation.
Here are the normal qualifier statements into our public company. In our agenda for today, I will provide a brief corporate overview and then Dr. Maggie Uprichard who is joining me will present our oncology programs. She'll discuss our Phase III program which was initiated in November of 2005, she'll also update on all of our Phase II programs. Then there will be a wrap up discussion around our corporate strategy, business strategy, and a summary.
Point Therapeutics is developing a group of novel dipeptidyl peptidase inhibitors to treat various diseases. Our lead product candidate, talabostat, is being developed to treat cancer. It has highly desirable drug development characteristics in that it is oral and is a small molecule. In our opinion, talabostat has great versatility as an anti-tumor agent in that it can treat solid tumors and hematological malignancies. In addition, it can be combined with other anti-cancer agents such as chemotherapy and monoclonal antibodies.
We have accumulated a significant amount of proof of concept data based on data from over 450 humans. Talabostat has a novel dual mechanism of actions in that it inhibits fibroblast activation protein the tumor stroma, and through the inhibition of another dipeptidyl peptidase causes stimulation of the innateand the acquired immune system.
Point is developing dipeptidyl peptidase inhibitors to treat cancer, type 2 diabetes and as a vaccine adjuvant. Talabostat is our most advanced program and is now in two Phase III trials in non-small-cell lung cancer. We also have ongoing Phase II trials targeting other cancers. Dr. Uprichard will give you the details later in the presentation. Our type two diabetes product candidate PT-630 and the vaccine adjuvant candidate PT-510 are both pre clinical stage programs.
Now let's talk a little bit about talabostat’s novel dual mechanism of action. First it is a stromal targeted agent that inhibits fibroblast activation protein, also know as the FAP, which is found in the stroma of tumors. We know that the FAP is up regulated in the stroma of tumors and researchers from multiple academic centers have demonstrated that FAP activity can promote tumor growth. Talabostat is a potent, high affinity inhibitor of FAP. We have demonstrated pre-clinically that talabostat inhibition of FAP causes an anti-tumor effect in tumor bearing mice.
Talabostat also causes immunostimulatory activity by inhibiting another dipeptidyl peptidase found in the tumor stroma, and in the bone marrow that causes IL-1? to be produced. The upregulation of IL-1? causes a cascade of cytokines and chemokines which expand the innate immune system such as neutrophils, macrophages and NK cells and the acquired immune system such as CTLs and memory cells. The chemokines play an important role because they attract these effector cells into the tumor where they then can perform cytolytic activity.
I'm pleased to report that we have additional efficacy data that we'll discuss today as our data continues to mature. An additional responder has been identified in our Phase II, non-small-cell lung cancer study bringing the response rate to 14.3% in a very advanced patient population. Secondly, one year survival in that study is currently 48% in the Phase II non-small-cell lung cancer study. Also, we have seen an additional clinical response in Phase II metastatic melanoma combination study, which leads to an 11.9% response rate, again in an advanced population.
Before Maggie provides her update, I would like to provide an overview perspective on the results we have seen to-date in our Phase II program. When you look at this score card of result, the bottom line is that talabostat has demonstrated compelling biological activity. In all Stage two -- Phase II studies, we are treating advanced refractory patient population. As an example; 35% of our Phase II non-small-cell lung cancer study was third linedpatient.
Our single agent metastatic melanoma patient was studied at Academic Medical Centers exclusively. And patients that would be viewed as salvage CLL patients are our target in our Phase II CLL program. To see biological activity in these patients is significant. In all of our trials, talabostat has demonstrated anti-tumor activity that included targeted response rates. In addition, we have seen durable complete responders in patients where you would not expect CRs. Progressive pre-survival and positive median survival results also have been seen. The composite results point to talabostat being a promising drug candidate.
Now I would like to introduce Dr. Maggie Uprichard, Senior VP and Chief Development Officer. Maggie will provide an overview on talabostat's Clinical Development Program. Dr. Uprichard joined Point in January of 2003. Prior to joining Point, she served as head of Regulatory Clinical and Preclinical Affairs for both Curis and Paion. Most of her career was spent at Warner-Lambert and Pfizer where she held senior positions in both Clinical and Regulatory Affairs. So, Maggie?
Margaret Uprichard - Point Therapeutics, Inc - SVP, Chief Development Officer
Thank you, Don. I'd like to begin by reviewing the rationale behind the strategy for the clinical development of talabostat. In an attempt to capitalize on the dual mechanism of action of talabostat, we wanted to explore its activity in both solid tumors and hematologic malignancies. In determining the tumor types and combination agents for study in the clinic, we were guided primarily by preclinical data and on unmet therapeutic need.
Preclinical studies yielded data supporting our Phase II studies, both in terms of tumor types and combination agents. Our Phase II studies were designed using traditional broadly accepted, statistically valid study methodology. We relied heavily on the import and advice of our scientific and clinical advisory board, as well as that of our investigators. The patients in our studies all have metastatic advanced cancers for which there are no or at best limited treatment options.
Achieving efficacy in advanced patients is a high hurdle. However, we believe that if the necessary treatment effect size is demonstrated, balanced of course by an acceptable safety profile, talabostat will provide a benefit over the existing standard of care, hopefully, thus, allowing it to reach the market and the cancer patient more rapidly.
Talabostat is not a typical cytotoxic anti-cancer agent. Therefore, to best exploit its mechanism of action, talabostat is being primarily study in combination with other anti-cancer therapies in most of our trials. We have however, evaluated the single-agent activity of talabostat in Melanoma, a known immunoresponsive tumor. All of our Phase II studies are open label, multi-center, single arm trials using a two stage design. The two stage design is a commonly used approach in cancer drug development.
Under this model approximately the first half of the patients are treated and followed for a pre-specified effect such as tumor response rate or survival. If the effect is achieved in the first group of patients, then remaining patients are enrolled. In most of our Phase II trials, the primary endpoint for moving from Stage one to Stage two of enrollment was tumor shrinkage or response rate. We have targeted a response rate of 10% to 20% in these advanced patients participating in the study.
In the Phase II study in Pancreatic Cancer we are using six months survival as the primary endpoint. Secondary endpoints are those typically studied in trials of anti-cancer agents and include duration of response, complete response, progression free survival or PFS and survival. I would like to review the data from the three Phase II studies that have completed enrollment. I will begin with the Phase II study of the combination of talabostat and docetaxel in patients with Stage 3B/4, that is metastatic inoperable non-small-cell lung cancer, who'd failed a platinum base treatment regimen.
The results of this study were presented at last November's AACR-NCI-EORTC meeting in Philadelphia. Platinum, usually combined with a taxane or gemcitabine is the standard of care of front line treatment in these patients. At the time the study was started, docetaxel was the only agent approved in the US for second line treatment. Since that time pemetrexed and erlotinib have also been approved from patients who failed front line therapy. The patients in our study had received up to two prior treatments regimens; that is they were second or third line patients.
Steady medication was administered in three week cycles. Docetaxel was administered on day one of each cycle using the labeled dosing regimen for non-small-cell lung cancer and appropriate pre-medication recommendations. Talabostat was administered for the 14 days following each docetaxel administration. The initial talabostat dose was 200 micrograms twice a day, and the dose could be increased to 300 micrograms twice a day at the discretion of the investigator depending on tolerability. After six cycles of combination treatment; talabostat single agent could be continued at the discretion of the investigator. CT scans were performed every six weeks for the treatment period and then every two months thereafter and patients are being followed for one year for survival and disease progression.
This slide shows patients demographics for all 55 patients who entered this study, the ITT population. 42 patients are considered evaluable for response. To be considered evaluable, patients had to have received at least two cycles of treatment with a post base line response assessment. The distribution of age and gender in this Phase II study is consistent with most studies in advanced non-small-cell lung cancer. The majority of patients in our study were Stage four, the most advanced stage in non-small-cell lung cancer. 36% of patients were third line patients, that is they received two prior treatment regimens. 55% of patients had received prior treatment with a taxane containing regimen.
Per the statistical model, five tumor responses out of 41 evaluable patients were needed for a positive Phase II study. Six of 42 evaluable patients or 14.3% had a response to treatment; this is an updated number from what was presented at the AACR-NCI- EORTC meeting in November. This slide summarizes the responses noted for the six patients, including two patients with a complete response or CR. Complete responses are not typically observed in clinical studies in patients with advanced disease, especially those who have failed other treatments. Interestingly the responses were observed across different study centers and histological sub types.
A CR was noted in both a patient with Stage four and one with Stage 3B disease and in one patient with adenocarcinoma and one patient with squamous cell histology. One of these patients with the CR, a third line patient, had failed prior treatment with docetaxel. The complete responses have been durable; they have persisted for more than eight months and the patients have not yet been reported to have progressed. Almost all responding patients went on to receive multiple cycles of single-agent talabostat, after completing the combination study regimen.
As you may be aware regulatory authorities seem to be moving away from response rate as an approval endpoint for clinical trials in non-small-cell lung cancer and are more in favor or endpoint such as progression free survival, PFS and survival. PFS is the primary end point in our Phase III studies. This slide shows the Kaplan-Meyer estimate for PFS in all 55 patients, the ITT population in our Phase II study. The median PFS is estimated at 4.2 months. This can be loosely compared with the historically reported PFS of 2.9 months for single-agent docetaxel in its Phase three trial.
This slide shows the survival curve for all 55 patients in our Phase II trial. The median survival is estimated at 8.4 months; the median survival for docetaxel single-agent in Phase III study is approximately 7.9 months. Importantly, the one year survival for the 40 patients' on our studies for at least one year is currently 48%.
We are very excited about the results of our Phase II study in this advanced patient population with non-small-cell lung cancer. We believe that the activity seen to date for the combination of talabostat and docetaxel is promising, especially the two complete responses one in a patient who had failed prior treatment with docetaxel. The complete responses appear to be durable, the median PFS, median survival, and one year survival are greater than that reported in historical Phase III studies of docetaxel.
The most frequently reported adverse events were edema, fatigue, neutropenia, and dyspnea. The results of our Phase II study suggest that the addition of talabostat to docetaxel may provide meaningful benefit in patients with advanced non-small-cell lung cancer in the second and third line setting. Therefore, we have initiated two randomized placebo controlled Phase III studies of talabostat and chemotherapy versus chemotherapy and placebo.
This slide shows a single-agent efficacy of the currently approved agents for treating patients with late stage non-small-cell lung cancer, who have failed front line treatment. It is shown to provide you with a comparison of the data derived from Phase III studies and the treatment effects seen in our Phase II trial. You will note that in the large Phase III study for docetaxel single-agent, data were obtained mostly in patients who were earlier in treatment, that is second line patients. Only 4% of the patients in this study were reported to have received two prior treatments.
The overall response rate in our Phase II study is 14.3% in evaluable patients and almost 11% in the ITT population. This response rate compares favorably with the historical response rates reported in Phase III trials of other agents. Median PFS is the primary endpoint in our Phase III trial, and the median estimates of PFS in our Phase II study is 1.45 times that reported in the Phase III study of single-agent docetaxel.
The estimate in median survival on our Phase II study is 8.4 months, compared with 7.9 months for single-agent docetaxel on the Phase III trial shown here. One year survival in our study is 48%, compared with 30% in the Phase III study of docetaxel. Now there are always some pitfalls in comparing Phase II data with Phase III data due to the fact in general, the patient populations in Phase II trials are more highly selected in terms of more rigorous eligibility criteria.
Eligibility for Phase III study, is usually somewhat less restrictive, to allow for broader extrapolation of results from the smaller sample size of a clinical trial to the entire real world patient population. However, in the case of talabostat the Phase III eligibility criteria are identical to those used in Phase II. Importantly, we are treating patients with unresectable non-small-cell lung cancer in the second or third line setting. All patients must have failed a platinum based treatment regimens. The randomization is stratified based upon stage of disease and number of prior treatment regimens, to ensure balance between the treatment arms.
If our Phase III studies are positive our proposed indication for talabostat will be in combination with chemotherapy for metastatic non-small-cell lung cancer, after failure of at least one prior chemotherapy regimen. The primary end point in the two Phase III trials in patients with metastatic non-small-cell lung cancer PFS, is consistent with the recommendation of the Oncology Community made at the December 2003 meeting with FDA, and with the FDA guidance issued in April 2005.
PFS is considered a stronger end point in the study of randomized blinded placebo control trials, and when independent radiological confirmation of disease progression is perceptively specified. Given this clear guidance on registration endpoints in non-small-cell lung cancer, we felt it unnecessary to request a special protocol assessment which would have likely substantially delayed the initiation of our Phase III studies.
We have initiated two randomized placebo controlled drug double blind trial, both trials will enroll 400 patients each, 200 per treatment group. The first trial compares talabostat and docetaxel to placebo and docetaxel. The second trial compares to talabostat and pemetrexed to placebo and pemetrexed. An independent third party review of CT scans to evaluate disease progression will be performed to determine the effect on the primary endpoint PFS. Both studies are powered to detect a 1.4 hazard ratio for PFS between the two treatment arms. Secondary endpoints include survival, tumor response and quality of life.
Now I would like to move on to our Phase II program in metastatic or Stage IV melanoma consisting of two separate trials; a study of single-agent talabostat and a study of talabostat in combination with cisplatin. Stage IV patients have the most advanced disease and there are few treatment options. Patients in our Phase two studies were allowed to have been treated with one other therapy for their Stage IV disease.
Both studies evaluated a 14 day treatment course of talabostat followed by one week off. Talabostat was initially given as 300 micrograms twice a day and could be increased to 400 micrograms, twice daily following the first cycle, if it was considered to be well tolerated. Talabostat could be continued until disease progression or unacceptable toxicity. The outcome measures have been described earlier. The results of this study were presented last November at the annual meeting of the International Society of the Biological Therapy of Cancer in Alexandria, Virginia.
This single-agent trial was conducted primarily at academic centers across the US. 42 patients entered this trial, 31 of whom were considered evaluable for response. The median, age, race and gender are all consistent with other studies in this patient population. The vast majority of patients in that criteria for classification is M1b. In other words, these patients had metastasis for the lung. Four M1c patients had a metastasis to other internal organs. These are the most severely advanced patient group.
64% of patients have received one prior treatment regimen, and of these patients 36% have received prior treatment with a cytokine based regimen. In this trial, single-agent talabostat in very advanced patients with melanoma, two patients responded to treatment. One had a complete, and one had a partial response. Both patients have progressed following prior treatment with cytokine. The patient with the complete response has enjoyed their response for more than nine months. The most frequently reported adverse events were edema, fatigue, hypotension and nausea.
The estimates in median PFS and survival are 1.5 and 7.1 months respectively. These estimates are comparable to those reported historically for the only approved intravenously administered cytotoxic chemotherapy for melanoma. The second trial in metastatic melanoma was a combination study of talabostat and cisplatin. Cisplatin was chosen as a combination agent as a result of strong preclinical data and advice from our clinical experts.
There is also a common component of multi-drug regimens used to treat melanoma and it is these regimens that tend to be associated with a survival benefit. Again patients in this study were allowed to have been treated with another therapy for their Stage IV disease. Cisplatin was administering on day one of each three week cycle, followed by 14 days of talabostat. Talabostat was initially given as a 300 microgram twice daily and could be increased to 400 micrograms twice daily, following the first cycle, if it was considered to be well tolerated. Talabostat could be continued until disease progression or unacceptable toxicity. Again the outcome measures were described earlier.
The high initial doses of cisplatin in this study, 100 milligrams per meter squared was difficult for patients to tolerate, leading to a high incidence of nausea, vomiting and ultimately non-compliance with taking oral talabostat tablets, and thus a high rate of unevaluability. About half way through this study, the dose of cisplatin was reduced to 75 milligrams per meter squared, and the use of anti-nausea agents was increased, which enabled completion of the study.
70 patients have been treated in this study, 42 of whom are considered evaluable for response. The median, age, race and gender are all consistent with other studies in this patient population. The majority of patients, again meet criteria for classification as M1b or M1c. 70% of patients are M1c, again the most advanced patients. 64% of patients have received one prior treatment regimen, and of these patients 73% have received prior treatment with a cytokine base regimen.
In this trial of talabostat and cisplatin in very advanced patients with melanoma; five patients, approximately 12%, had a partial response to treatment. Three of these patients had metastasis to the lungs, and two had metastasis to the abdomen or liver. Two patients have progressed following prior treatment with cytokines, and three had no prior treatment for Stage IV disease. Two responses are continuing. The most frequently reported adverse events were nausea, fatigue and vomiting. The estimated median PFS is 2.8 months. This PFS compares favorably to other two drug combination studies in advanced melanoma. At this time median survival cannot be calculated, due to the high rate of unevaluability.
We are very encouraged by the results of these two initial Phase II trials in patients with advanced melanoma. The results observed in the single-agent trial of talabostat showed activity of this oral agent in patients who had progressed on cytokine treatment, including a patient with a durable complete response. The activity in combination with cisplatin in patients with wide spread metastasis is also encouraging, but the potential of talabostat in combination with chemotherapy has not really been adequately characterized due to the high unevaluability rate, as a result of cisplatin associated nausea and vomiting in our Phase II trial.
Further Phase II comparative studies of talabostat in combination with other anti-melanoma agents are warranted. However, it is necessary for us to prioritize our internal resources accordingly. Our current resources are primarily directed towards the Phase III studies in non-small-cell lung cancer and completion of our other ongoing Phase II two studies. We will continue to evaluate opportunities to conduct additional clinical studies in melanoma as the year goes on.
Now I'd like to move to our ongoing Phase II study of talabostat and Rituximab in patients with advanced chronic lymphocytic leukemia who have failed a fludarabine-based regimen. Most of the enrolled patients have also progressed following treatment with Rituximab. Fludarabine is the standard chemotherapy in patients with advanced CLL. If patients have progressive disease after fludarabine, the only approved agent in US is alemtuzumab.
This is a single arm multi-center study in patients with advanced CLL classified as Rai's Stage III or IV. Rituximab is administered in the approved dose and schedule for non-Hodgkin's lymphoma, 375 mg per meter squared weekly for four weeks. Talabostat 300 microgram is administered twice daily for the six days following each infusion of Rituximab, for a 28 day course of treatment. Courses can be continued at the discretion of the treating oncologist. Outcome measures include; response rate, PFS and survival.
Results from the first half of this study were presented in December at the annual meeting of the American Society of Hematology in Atlanta Georgia. And I should mention that this study is also funded in part by the FDA Office of Orphan Products Development. Seven of 33 evaluable patients have had a partial response to study treatment. As you can see all patients have been heavily pretreated.
Five of the seven responding patients had progressive disease following prior Rituximab treatment, and three of these had also received alemtuzumab and then progressed. Given the advanced nature of the disease in these patients, these results are very encouraging. We are continuing to enroll patients into this study and expect it will be completed by the middle of this year. In this study, by adding talabostat to Rituximab, we have been able to elicit a response in patients who have failed prior treatment with Rituximab.
Responses have also been observed in patients who failed alemtuzumab the only agent approved for fludarabine refractory patients. The most common adverse events are those usually seen with Rituximab with the exception of a higher incidence edema in our Phase II trial. We continue to enroll patients and we expect to provide an update mid year.
We are also currently conducting a Phase II study of talabostat in gemcitabine in patient with Stage IV pancreatic cancer. At the time this study was started, gemcitabine was the standard of care in these patients.Preclinical studies of talabostat and gemcitabine show a highly synergistic effect, and pancreatic cancer is know to highly express FAP, making it a good target for talabostat. This is an open label, multi center, single arm, two stage study in up to 60 patients with Stage four Pancreatic Cancer. Gemcitabine is administered for four cycles using a labeled recommendation, and talabostat is administered for six days following each infusion of gemcitabine. Single-agent talabostat may be continued beyond four cycles.
The primary endpoint in this study is six month survival. Other end points include; overall survival, PFS, quality of life and performance status. We anticipate that results of the first stage of this study will be available in late summer of this year. In order to maximize the potential of talabostat, a number of investigator sponsored trials in other tumor types are on going or are soon to be initiated. Investigator sponsored trials provided a way to get a preliminary glimpse of anti-tumor activity in a single center model.
The cancers being studied or planned for study include advanced colorectal cancer, Pediatric solid tumors, Renal Cell Carcinoma, esophageal or gastric cancer and metastatic Pancreatic cancer with chemoradiation. That concludes the overview of the status of the talabostat clinical program.
I'd like to reintroduce Don Kiepert, who will provide the corporate update.
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
Thank you, Maggie. And I appreciate the leadership you have shown in driving this program forward. I would like to now just summarize the key milestones and news flow that we'll be reporting on in 2006. First in the clinical area as Maggie pointed out, by mid year we'll have our completed CLL Phase II results. Our pancreatic cancer study, our Phase II trial, we’ll have interim results in mid year that we will report on, and then the final results end of 2006 or Q1 2007.
We will continue the strong momentum we have established with scientific presentations. We've been accepted for presentation on our PT-630 program at the Keystone Symposium, which is a symposium that covers metabolic diseases. We will be presenting at AACR some new pre clinical data that our research team has completed. We hope to have a major presence at ASCO, at the ADA and at ASH at the end of the year. In addition, we are scheduling and planning corporate presentations.
I talked a little bit earlier about our mechanism of action, and we now have further elucidated and understand the target on the dipeptidyl peptidase that is causing immunostimulation, we have some data to show the activity of FAP and our compound in inhibiting FAP, and we would like to present that to the investor community and scientific community to an analyst day that we are scheduling in New York end of March or early April.
We also have decided to initiate quarterly calls surrounding our financial reports and that will serve as an opportunity to update on progress and plans as we move forward. In an effort to determine talabostat's revenue potential, we have completed market research and revenue forecasting projects. We conducted market research with 100 US oncologists from both academic centers and community based practices.
The Oncologists felt that talabostat has broad potential across tumor types based on the profile of the drug. They suggested that there would be a rapid uptake within three years with a target market penetration of 40% to 68% across indications. In particular, in our most advanced program, they indicated they would likely use talabostat in 66% of their second and third line non-small-cell lung cancer patients.
Additionally, we proposed an approximate selling price to gain their insight. All of this data was then used to develop and establish a global revenue forecast with the help of the Mattson Jack Group. The Mattson Jack Group is a leading market analyst consulting firm, that works exclusively with the pharmaceutical and biotechnology industry. The results indicate a billion dollar plus global opportunity, based on a launch date of Q4 2008.
Securing a strategic alliance is the company's first business priority. We're dedicating substantial resources to evaluate and negotiate with prospective partners both in the US and abroad. We understand that it would be advantageous to have a partner who would commit to clinical development resources to assure talabostat's full potential is realized. Our partner should also have strong distribution capabilities, to assure optimal market penetration.
In light of talabostat's value and potential as a multi billion dollar opportunity, we're considering all alternatives. Some of the significant deal terms we're pursuing include co-development and co-promotion features. Ideally we would like a share in the profits with our partner. We are targeting a collaboration by the second half of 2006. However, we are committed to making sure that we are executing the right deal with the right partner at the right time. We are making progress in this priority.
To summarize, talabostat is a Phase III cancer product candidate, that it is the first DPP inhibitor in advanced development for the treatment of cancer. It is an oral agent that potentially offers patients and physicians convenience in dosing flexibility. The clinical data suggests that talabostat can be safely combined with multiple anti-cancer agents. Ongoing Phase II trials suggests potential utility and a broad range of tumor types with various other anti-cancer treatments. This all suggests the possibility for a billion dollar global opportunity.
I'm extremely proud of how our company has evolved through the years. From the beginning we've remained steadfast in building a clinical program and business culture that is both strategic and opportunistic. As the clinical programs evolve, we have bolstered our team with key additions both in-house and advising.
I want to thank our shareholders for staying the course, because with one Phase III program underway and multiple Phase II programs engaged, this company is truly on the cusp of realizing its potential. Being one of the first to leverage DPPs in Oncology represents an awesome opportunity to not only make a medical impact, but to serve as a catalyst for DPP inhibitor applications beyond diabetes.
So now I would like to open the Webcast up for questions that might have been sent in, and I’d be happy to answer any of those questions at this time.
QUESTION AND ANSWER
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
If you would like to send in a question there is a Q&A link right at the top of the slide that you can click on, and that would allow you then to send in the question.
Unidentified Audience Member
There is a question. How do you believe that the investigators viewthe drug?
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
So the question is, how do we believe the investigators view the drug? And I will turn to Maggie to ask her the question, to answer that question please.
Margaret Uprichard - Point Therapeutics, Inc - SVP, Chief Development Officer
Investigators are very encouraged by the clinical results that we've seen to date. If they were here they would tell you that they like the fact that talabostat is an oral drug, and it is easier for patients to take. One of our investigators has suggested that -- that the patients like oral drugs because they feel that they are more in control of their disease. So investigators are looking forward to studying talabostat in additional trials and participating in the randomized Phase III trials.
Unidentified Company Representative
We have another question.
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
Let me just read the question again for Maggie. Can you talk about how initial enrollment is progressing in the Phase III non-small-cell lung cancer trial and what is your target time for initiating the Alimta trial? There's couple of more questions to go along with this, but maybe we can target those initially.
Margaret Uprichard - Point Therapeutics, Inc - SVP, Chief Development Officer
Okay. the initial enrollment is proceeding quite well, the holidays always cause a little hiccup in enrollment, but we are at the pace that we wanted to be in the docetaxel study and we expect the first patient in the Alimta trial shortly. We have drug at the sites; we've IRB approval and the sites are actively screening patients.
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
And there is a follow-on question here Maggie. Are there any concerns about effect of blinding of the study through the edema?
Margaret Uprichard - Point Therapeutics, Inc - SVP, Chief Development Officer
Well as I'm sure you are aware edema is also the most frequent complication of docetaxel. So in that particular trial, I don't anticipate unblinding to be an issue with respect to the side effects. I actually don't expect it to be a problem in the Alimta study either. Because a lot of these patients will have other comorbidities, they will be on—anti-hypertensives, they'll be on diuretics. So they may have edema just as part of the course of whatever disease that they have. The edema thus far has been manageable mild and generally reversible. So, again it is not something that would jump out and say okay here I am I have an adverse event I'm taking talabostat.
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
And the last part of that question is, should we expect collaboration potentiallyprior to the Phase II pancreatic data? As I pointed out earlier, the Stage one pancreatic data is scheduled to be released mid year. And then, the completed Phase II data will be Q4 of Q1 of 2007. I think I also indicated that we are targeting a collaboration in the second half of this year. So it is very hard for me to predict whether or not that collaboration will happen before or after the pancreatic study.
I think if anybody who's been involved in putting collaborations together, I think everyone is aware that it is very difficult to predict an exact time when you can execute the deal. I think what's really important for us, and this has our full and undivided attention, it's not only to get a deal done, but to get a deal that is commensurate with the market opportunities for a drug like talabostat. So, I know I can't say when the deal is going to happen, but I can tell you that we are as a top priority in the company, focusing our efforts on securing the right deal with the right partner.
Unidentified Company Representative
And then there is a follow-on question. Have you considered taking talabostat to the market without a partner?
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
Question is, have we considered taking talabostat to the market without a partner? This is a drug, as we talked about the multibillion dollar potential. Any net present value calculation would say, the further you take the drug the more value you are going to create. However, this is a drug that has the potential to be in many different Phase III programs that would require a lot of capital. So I think, the more likely scenario is that we would find a collaborator, who would have the clinical resources to invest in assuring that we are leveraging the potential of this drug across all of these cancer indications.
So for us, the clear priority is finding a partner to collaborate. In addition, this is a drug that could benefit from a strong distribution channel. And a partner would, the right partner would obviously bring that to the table. So, the clear priority for us is finding a partner to help us develop the drug and help us promote the drug into the market place.
Unidentified Company Representative
Next question is. Could you please clarify what range of progression freesurvival you’ll need for a positive Stage III non-small cell lung cancer trial? Specifically, what does a 1.4 hazard ratio mean?
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
Let me just re-state the question. The question for the webcast participants, the question is can you talk about the endpoints that we will need to achieve in our progression free survival endpoint as it relates to our Phase III program? And what does a 1.4 hazard ratio mean?
Margaret Uprichard - Point Therapeutics, Inc - SVP, Chief Development Officer
Well 1.4 hazard ratio means that the talabostat treatment arm needs to be 1.4 times better, than the chemotherapy treatment arm in order to have a positive study. There is no range that I can state right now, because there really isn't a range - it's really more of a discrete time point.
However, we powered this study and determined the PFS improvement needed based upon the data I showed you earlier, comparing what we are seeing in Phase II versus what has really been consistently reported for docetaxel in the Phase III setting. So our PFS is currently estimated at 4.2 months. And if you compare that to the 2.9 months for docetaxel, and do the calculation if you get to 1.4 hazard ratio, it's about 4.1 months that we'll need to achieve in terms of PFS, if the docetaxel arm lives up to what it's done historically in the 2.9 mark.
Now I think I should point out that, in the docetaxel studies that PFS was observed under unblinded conditions, and we are using an independent third party radiology group to look at the PFS. So, it will be interesting actually to see under blinded conditions, what the true PFS is for docetaxel.
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
And one point to reemphasize the 2.9 months in the largest docetaxel study was in 96% second line patients and 4% third line. Our 4.2 months, was in approximately 65% second line and 35% third line, which is a much more difficult population to obtain results in.
Unidentified Company Representative
Next question has to do with [inaudible] do you know of any other companies that are working [inaudible]?
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
Well I think it's positive -- I will restate the question. Recently Genentech published an article on FAP being a target for developing anti tumor drugs, anti cancer drugs. Are we aware of any other companies that are working on FAP inhibitors?
Well first I think it's a very good validation that a company of the stature of Genentech and quality of Genentech has identified FAP as a target that should be pursued. We clearly have a drug that's the furthest in development down the pathway, and when you look at our drug’s ability to inhibit FAP it has very high potency and very high affinity. So we think that the fact that FAP is now becoming a well established target is a positive validation for our company. We are unaware of any other company that's working on FAP inhibitors at this time, and we are not aware of any that are in clinical development.
Unidentified Company Representative
Next question is [inaudible].
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
–I’d be happy to clarify; the study that we did was based on input from 100 oncologists, and we basically laid out for them the profile of the drug and then asked them a series of questions. And we are encouraged by the results that we saw; within three years market penetration of 40% to 68% across the different indications. And basically, when you take that input plus a preliminary pricing model which we validated with the doctors, a conservative pricing model, we were able to see that this drug post launch, within two to three years would be a billion dollar drug, and past that, four to five years world wide has the potential to be a billion plus dollar agent.
Unidentified Audience Member
Next question is that, is there any way to -- in your Phase III study given the clinical nature of the Phase II and [inaudible].
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
Because -- the question here is because we have similar eligibility Phase II versus Phase III, is there any likelihood that the Phase III group might be able to respond better, than the Phase II?
Margaret Uprichard - Point Therapeutics, Inc - SVP, Chief Development Officer
I don't anticipate them responding any worse than the Phase II study, but until we do the study we really won't know what the true magnitude of the response is.
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO
Are there any other questions?
Unidentified Company Representative
None.
Donald Kiepert - Point Therapeutics, Inc - Chairman and CEO |
